Joe Manchin

Mr. MANCHIN

Mr. MANCHIN. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. MANCHIN. Mr. President, I rise today to discuss Presidential nominations. I think most people in this body know I am probably one of the least partisan people--looking at the issues, working across the aisle, always reaching out to my friends and colleagues on the other side of the aisle. I don't look at the barrier a lot of people look at here. I know we are able to debate and we are able to advise and consent on nominations because we just did it. I have a tremendous problem in my State, and I think in all of our States--Colorado and all across the country--with opioid addiction and drug abuse. With that being said, I truly believe that for us to fight this war, we have to have a cultural change within the FDA. The President of the United States nominated Dr. Robert Califf, a very good man, but a person who came from within the industry and who I did not think would bring a cultural change. Still, he was the recommendation of the President. The majority leader from Kentucky basically brought that to the floor for a vote. I thought it was the wrong person, even though this was a nomination from a President of my party, and me being a Democrat. So I think it is a misnomer for us to believe we are going to hold hard to party lines. I have said that I didn't think Dr. Califf would bring the cultural change. I hope he proves me wrong. I am willing to work with him on that, and I will fight to make sure we rid this country of the scourge of legal prescription drug abuse that is ruining families and destroying lives. I think we have proved the President can bring people up, which is his responsibility, and we can look at that person and agree. In this case, I had only four votes on my side. The majority of all the Republicans but one--yes, all the Republicans but one--voted for him. I still think it was wrong, but we are going to make the best of it that we can. The bottom line is we did our job. We truly did our job, and I can live with that decision. I look at the Constitution, and it is very clear. It says the President ``shall.'' It doesn't say ``may.'' Being in the legislature--and the Presiding Officer has been in the legislature as well--the words ``shall'' and ``may'' are worlds apart. It says ``shall,'' and we know he will nominate. Why are we not willing to go through this process? I am as likely to find someone he might recommend who I will not vote for as maybe the Chair and maybe our other colleagues. I saw what happened when I first got here. We got condemned for not voting at all. We weren't getting any votes because there was protection going on. Basically, for whoever is up in the cycle, tough votes make it very difficult for people to get reelected. We proved that to be wrong because basically we saw a big switch in the Senate from the majority to the minority and the minority to the majority. I have said very strongly that no vote is worse than a tough vote. A no vote in this body is worse than a tough vote. If you are saying that you would rather not vote at all because it might cause a problem back home, I think we have more problems if we don't do our job. That is why I can't figure this out. If the President brings a person up, there is going to be 2 or 3 months, and if we can't find someone we can agree on--60 of us--that means it will take at least 14 Republicans to find someone they can agree on and they think is good for the country and move forward. If not, then it will run right into the next administration, whoever that may be. But basically we would be doing our job. I just have a hard time on this one. I am going to evaluate that nominee based on their legal qualifications and judicial philosophy. I am going to look and basically see what type of jurist they have been, what types of decisions they have made, what types of social media they have been on, and what they have talked about. I will look at all of that, which is what we should be doing, to find out as much about that person as I can and to see how they will govern and rule in the future. Hopefully we will find someone who will look at the issues, look at the rule of law, and look at who we are as a country. I think we all can do that. I know very well the Chair can. I know very well every one of our colleagues on both sides of the aisle is able to do that. I don't believe the President can count on all Democrats, just because he is a Democrat, falling in line. If that were the case, we wouldn't have had Senator Markey of Massachusetts, Dick Blumenthal, and I voting against Robert Califf, who was the President's nominee. So we are going to have to find that right person. But if we never get the chance to evaluate the person, I don't know how we can do that. Again, it truly gets down to the fact that this is the job we are supposed to do. We talk about orderly business. We are getting things done. I have heard people say: Oh, yes, we are getting things done now that the Republicans are in the majority. The Chair has been here long enough to understand that the majority might set the agenda, but it is the minority that drives the train as to whether we get on something or not. So we have to work together. We have proved the old game plan didn't work. The new game plan is fine. Let's have an open amendment process, let's go through it and debate it, and then let it go up or down on its merits. That is what we are asking for on this. Let it go to committee. When the nomination comes, let it go to the committee and look at the nomination. I mean dissect it in every way, shape, or form, whoever that person may be--he or she. I am willing to live with whatever the committee comes out with, and I am going to do my own research. When it comes to the floor, there is no guarantee that I am going to vote for that person-- absolutely not. And I have already proved that. All of us have proved that we haven't just blindly followed party lines, nor should we. We aren't expected to. Our constituents don't expect us to do that. They do not want us to do it, that is for sure. Again, the Constitution states that the President ``shall nominate, and by and with the Advice and Consent of the Senate, shall appoint. . . . '' He can appoint only if we have the advice and consent of the Senate. There is no other way this President or any other President can make that decision. We make the final decision. Again, we are to the point now where the rhetoric is back and forth and it gets a little harsher and everybody gets ingrained, entrenched: By golly, we are not going to take anybody up; we don't care who that person will be. And I just hate to see that. We are all friends. We all know each other, and we all truly, I believe, are here for the right reasons and want to do the best job we can. But we are still expected to do our job. At the end of the day, did you do your job? Yes, we looked; the President gave us somebody; we didn't think that person was qualified; we didn't think they were centrist enough; they didn't have the background or a record that we could extract what we felt their performance would be in the future; and for those reasons, we voted against that person. Or the President gave us somebody who basically we found did not have political ties to either side, who basically ruled on the law--the best interpretation of the law--and with the Constitution always at the forefront. That is the person he gave us, and that is the person we would support. But if we never get a chance to look at whoever is given to us, there is no way we can move forward. When I was Governor of my great State of West Virginia, I had to do the job 24 hours a day, 7 days a week, every minute of every day, every day of every week, every week of every month, every month of every year. It was expected. That was my job, and I tried to do the best I could. There were some times when I had to make some tough decisions. There were times I drew people together and times when there was so much division that we had to basically let it cool off and then move forward. But we always kept trying to do a better job for the people of West Virginia. I think the American people expect us to do a better job. I really do. I don't care who gets credit for it--Republicans, Democrats. Basically, it should be all of us because the way this body works, it takes 60 votes to get on something, if we want to make that the criteria. With that being said, I can assure you there will not be a person the President of the United States gives us--whether it is this President or the next administration and the next President--who will be the perfect jurist. We are not going to find that perfect jurist. We are not going to find someone slanted too far to the left or too far to the right so that we can't get 60 votes. We are going to have to find somebody who has shown some common sense and has some civility about them, basically using the Constitution as the basis and framework for the decisions they made as a jurist, and show that is how they are going to govern in the highest Court in the land and be a model for the rest of the world, reflecting that we are still a government of rules. We are a body where the rule of law means everything. It is hard for us to do that if we can't find someone who we feel is qualified to do the job. So, Mr. President, I urge all my colleagues--all of my colleagues in this great body and all of my dear Republican friends--to look and think about this. If the right person is not there, don't vote for them. As a matter of fact, I would probably vote against them too. I have before. I think I am the most centrist Member of this body, and I am going to vote for what I think is good for my country and for the State of West Virginia. I think the people of West Virginia expect me to do that, and they expect me to do my job too. With that, I hope we have another opportunity to think this over. The President probably will be giving us somebody in very short order. I would hope we are able to move to where the Judiciary Committee is able to look at that person, give us their findings on that person, and either tell us why we should not advise the President we are going to consent or find a person we can all agree upon and move forward. With that, Mr. President, I yield the floor. Mr. President, I suggest the absence of a quorum.

Mr. MANCHIN

Mr. MANCHIN. Mr. President, I ask unanimous consent to speak for up to 10 minutes.

Mr. MANCHIN. Thank you, Mr. President. Very few people know what is actually happening in your life. In order to get help, you have to be willing to openly talk about your issues, and most of us fear being harshly judged--and rightfully so. Trying to treat a person with addiction issues by using medication only or therapy only is like trying to extinguish a raging house fire with a garden hose. She said: I was fortunate enough to have found a medication-based treatment program in my area, which is paid for by my insurance. She is going to move forward, and she wanted this story to be told. She said she wanted people to know how difficult it is. What we need to know as policymakers is how hard it is for people in our States who realize they need help and can't find it. So what I ask all of us to do--this CARA bill is a step in the right direction. It is a piece of legislation that is much needed. As we move forward today on this piece of legislation, I hope we will find basically the support that people are needing to fight this opiate addiction. Thank you, Mr. President. I yield the floor. Cloture Motion

Mr. MANCHIN. Mr. President, I wish to thank the senior Senator from Vermont, who is a dear friend of mine. As he knows, this is a problem. It is an epidemic all over this country. No State is immune from it. It doesn't matter whether you are a Democrat or Republican. It has no home. It attacks and literally eradicates all of us, and it causes extreme hardships for all the families. I know the Presiding Officer, who is from Indiana, is aware of this problem. Every week I have come to the floor to read letters from people who have been affected by addiction in West Virginia and other States. I have a letter from the Presiding Officer's home State of Indiana, and I have a letter from my State too. This is something we have been fighting. The CARA Act is a bipartisan piece of legislation. It is not going to be a cure-all, but it starts in the right direction for us to start looking at opioid addiction and prescription drug abuse, not as much as we have in the past as a crime but as an illness, and an illness needs to have treatment. I think we are moving in that direction. Politically we are accepting this, and we are going to basically meet that need of treatment which is so few and far between. We have 51 people dying every day. In my little, beautiful State of West Virginia, just last year we lost over 600 lives to prescription drug abuse, and I have a State with less than 2 million people. From 1999 to 2013 there has been an increase of over 700 percent. This is a product which has come on the market that is greater than anything we have ever seen. We hope the FDA gets serious about this. They are hearing us loud and clear. Dr. Califf was not someone whom I supported. I am very hopeful he will do a great job, and I will support him. He needs to step up to the plate and change the culture of the FDA. The reason I say that is because the FDA has to take their role seriously and not just approve drugs because it meets a certain criteria but also needs to realize the impact it has on the well-being of the families who have been addicted and affected. They need to consider the devastating public health impacts of its repeated decisions to approve all of these drugs that don't need to be on the market. We are very hopeful for that. The thing that brings that to mind is that it took us forever to get Vicodin and Lortab from a schedule III to a schedule II. It took us over 3 years. Once we did, it took about 1 billion pills off the market, which resulted in a 22-percent decrease in Vicodin and Lortab, which were being passed out like M&Ms. We know it can save lives. Yet they came right back with Zohydro, which was against the wishes of their advisory committee. We believe it is imperative that they have an advisory committee for every opioid they want to bring to the market. They must listen to the advisory committee. If the FDA--the Commissioner and his staff--wishes to go ahead and put a product on the market that is recommended not to be on the market from their advisory committee, they should come before us in Congress and tell us why they believe this potent drug such as Zohydro is needed when it is against the recommendations of these experts and specialists. We have been flooded with these stories. I will read a story from the Presiding Officer's State of Indiana first. The girl's name is Danielle. She says: I live in Southern Indiana and work as a server. About 2\1/2\ years ago a customer by the name of Josh Harvey left me his number. At the time, he told me he was living in Chicago for school. Little did I know he was in rehab there. Granted, I didn't know about his addiction for over a year because we hadn't stayed in constant contact. About a year or so ago I found out about his heroin addiction. He still told me little about it. I do know it started out with prescription pills and later went into heroin when the pills became harder to get. He served a month in jail in Michigan, for the entire month of this past July, over a heroin-related charge. He came home immediately after and overdosed that same weekend. Luckily, his dad saved him that time. Now he got enrolled in college and was going to an outpatient program doing better--or so we all thought. School let out for break and I guess it all went downhill. He came to me on November 4 telling me he had used a couple of times and wanted my advice. I suggested an inpatient program. He went to Wellstone after he left my house, sat for several hours and finally was given a room. I went and checked on him two different times while he waited to make sure he was there. Thursday I didn't receive any calls. Friday nothing either. Then, Saturday morning, the 7th of November, his mother called me to break my heart. He had passed away that Friday the 6th over in Louisville and they didn't know who to contact until that Saturday morning, I guess. He had checked himself out of Wellstone, broke into his house, and took his Xbox, which he later either pawned or traded for heroin. Never in a million years did I think I would become close to anybody addicted to heroin. It doesn't discriminate. It can get a hold of anyone and everybody. Never in my life have I been so depressed or heartbroken. All I want is his story shared. He was my happy ending gone way too soon. That was from our friend in Indiana who wanted to share her story with us. Let me tell you about Amanda, who lives in West Virginia. Amanda said: I walked into our new apartment. Although we had only spent 2 nights there, it already felt like home. I was so excited to move in with Nate. We had been on the fence between being best friends and a couple, and making the decision to move in together had finally settled years of uncertainty. As I turned the corner, I was surprised to see that he was in the exact same position as when I had left for my morning classes. I knew it had been a rough night of ``partying,'' but I thought he would be up to start our busy day of painting and moving. I touched his chest to feel the rise and fall, something that, as a mother, I had been doing to sleeping children for years. There was movement. He was breathing. I breathed a quick sigh of relief. I walked to the back of the apartment to set down my things, and that is when I realized I needed to go and get some things from my old apartment, and I started to leave. My hand was on the doorknob, but something stopped me in my tracks. To this day, I don't know why I turned around. I laid down beside Nate, and I put my arm on his chest. He was not breathing, and when I looked up at his face, his eyes were wide open, but it was obvious that he was not there. The paramedics revived him to the point that he survived in a coma for 1 week. At one point while in the hospital, his eyes opened, and I thought that our nightmare was over, but it was just a muscle reflex and false hope. On January 30, 2007, prescription drugs took the life of Nathan Keith Dunn, age 24. Tall, dark, and handsome is what the world saw. Intelligent, funny, witty, loving, and kind were the qualities seen by those who knew Nate best. He was my best friend, my musical soulmate, and my sounding board. We were inseparable, and I began to experience an ache in my heart that, 9 years later, still occasionally brings me to my knees. But that is just who Nate was to me. He was also the older son of a mother who had left years of abuse at the hands of her husband in order to find a better life for her sons. He was the brother to--and the only soft spot of--a boy who had been hardened growing up on the streets of a town outside of Houston, TX. It seemed as if the only thing that ever kept him grounded was Nate's love. They had one another's back in the best and worst of times. Nate was also the instant crush of any girl who ever laid her eyes upon him. He was the best friend of anyone who knew him. I often wonder who and where he would be today. But I guess I will just have to wonder forever. I wish this was the end of my story about how prescription drugs have affected my life, but it is not even close to the end. For longer than I care to admit, drugs have been part of my everyday life. Shortly after Nate's death, I became addicted to prescription opiates. At first, they were prescribed by my doctor. Eventually, I couldn't get through a day without them. I was what is sometimes referred to as a ``functioning addict,'' although it is fair to say that such a thing does not exist. To the outside world, I appeared to be fine, normal even. I held a job. I cared for my young sons. I kept a tidy home. Meanwhile, my tolerance was building, and I began to require more and more of the drugs just to feel normal, just to get through each day. Can you imagine living this life in which you wake up each day wondering if you have enough of the drug you need just to be OK for that day? So many people are facing this every single day. It could be the person sitting next to you. It could be your child's teacher. Even worse, it could be your own child. The first thing to suffer was my financial situation. Every dime I had was spent on the drugs that would allow me to function today, tomorrow, and if I am lucky, the next. Then, my relationships with friends and family began to fail. It was painfully obvious that I was stealing from them. Next, I couldn't keep a job--a record that will haunt me for the rest of my life. How could I go to work? How could I continue on? Then, a catalyst walked into my life. I met a very good man. As we became closer, I realized that I couldn't bring myself to tell him that I was a drug addict. This is a silent killer. Nobody speaks; they all keep it very quiet. Mr. President, if I may have about 1 minute to finish up, I would appreciate it.

Mr. MANCHIN

Mr. MANCHIN. I thank Senator Murray, Senator Alexander, Senator Grassley, and all the people who have helped me in considering this bipartisan amendment with a bipartisan piece of legislation. If we want to stop opioid addiction, we ought to start by preventing it. Preventing it starts with information and education that people do not have today. This helps every one of us in all parts of this great country. I yield the floor.

Mr. MANCHIN. Mr. President, I ask unanimous consent for 30 additional seconds.

Mr. MANCHIN. Mr. President, I rise today to urge my colleagues to vote in favor of my amendment No. 3420 to the Comprehensive Addiction and Recovery Act of 2015. As my colleagues know, our country is facing a prescription drug epidemic. Every one of our States--all 50--is having a horrific problem. The CARA Act that we are working on and are about to pass is a good start to addressing this crisis, which is why I am a proud cosponsor. My amendment simply does what you would think common sense would already entail. My amendment improves the bill by helping those on the frontlines of this terrible epidemic provide their communities with the information they need to help stop the spread of opioid addiction and help seek treatment. It will better enable us to educate individuals about the dangers of opioid abuse, practices to help prevent opioid abuse, including the safe disposal of unused medication, and how to detect the early warning signs of addiction. This amendment will help to save lives by raising awareness about the dangers of prescription opioid medications to prevent opiate addiction in the first place and ensuring that loved ones will know how to help when a friend or family member becomes addicted. We have over 2 million Americans who are addicted to opioids. Many of these individuals began the road to addiction with a seemingly innocent prescription and little or no warning about the dangers from their physicians. Or it began when a friend offered a pill that they thought couldn't be that dangerous because it was prescribed by their doctor. There is simply too little understanding about the dangers of these drugs. Too many people get sucked into opioid addiction because they don't understand the risks. Likewise, the people close to them don't recognize the signs of addiction or know how to access the resources to help their loved ones.

Mr. MANCHIN. Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.

Mr. MANCHIN. Mr. President, I call up my amendment No. 3420.

Mr. MANCHIN. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. MANCHIN

Mr. MANCHIN. Mr. President, I ask unanimous consent that the order for the quorum call be dispensed with.

Mr. MANCHIN. Mr. President, I rise today to speak in support of the Comprehensive Addiction and Recovery Act of 2015, which is bipartisan, I might add, and to discuss several amendments that I have submitted. Mr. President, our country is facing a prescription drug epidemic, and today is a good step toward addressing this crisis. This is a crisis I have been dealing with since my days as Governor of the great State of West Virginia. Opioid abuse is ravaging my State of West Virginia and many other States. I know the Presiding Officer has the same problem in Utah. Our State has been hit harder than any other State in the country. Drug overdose deaths have soared more than 700 percent since 1999. We lost 627 West Virginians to opioids last year alone. Mr. President, 61,000 West Virginians used prescription pain medication for nonmedical purposes in 2014. This includes 6,000 teenagers. Our State is not unique. Every day in our country, 51 Americans die from opioid abuse. Since 1999 we have lost almost 200,000 Americans to prescription opioid abuse. The fact that we have with the bill in front of us is simply this: It is an important first step. It will authorize $77.9 million in grant funding for prevention and recovery efforts, which we need, and expand prevention and education efforts particularly aimed at teens, parents and other caretakers, and aging populations. It will also prevent the abuse of opioids and heroin and promote treatment and recovery. It will expand the availability of naloxone to law enforcement agencies and other first responders to help in the reversal of overdoses to save lives. It will expand disposal sites for unwanted medication to keep them out of the hands of our children and adolescents. It will also launch an evidence-based opioid and heroin treatment and intervention program to expand best practices throughout the country. It will strengthen prescription drug monitoring programs to help States monitor and track prescription drug diversion. While the bill is a good start and addresses critical problems, there is more that needs to be done. I have a few amendments I want to speak about and explain that I think will improve the bill by changing the FDA mission statement, providing grants for consumer education, and requiring prescription prescriber training. First of all, I firmly believe we need cultural change at the FDA. That is why I submitted the Changing the Culture of the FDA Act as an amendment to this bill. This amendment would strengthen the actions that the FDA recently announced that they were committed to taking into consideration the public health impact of approving opioid medications. Mind you, what they said is that they were committed to taking it into consideration. I don't think that is much of a change, and it is definitely not a cultural change. It is a movement in the right direction, which I acknowledge. By solidifying this commitment in the agency's mission statement, we ensure that the agency oversees the approval of these dangerous drugs and cannot waiver from their stated goals. The language in my amendment is similar to the language in the FDA's current mission statement regarding tobacco, and we all know the devastating effects of tobacco. The mission statement says simply this: ``FDA also has the responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.'' If we think it is that serious that we put this in the mission statement for tobacco, why can't we do it for opiates? Tobacco kills hundreds of thousands of Americans every year, and we have rightly recognized this as a public health crisis. However, opiates killed more than 18,000 people just by the end of 2014. That is 51 people every day. This, too, is a public health crisis. It is absolutely ridiculous that the FDA has treated opiates like any other drug up for approval. To date, the agency has failed to consider the devastating public health impact of their repeated decisions to approve dangerously addictive opiates. We have seen that in their resistance to rescheduling hydrocodone, their approval of Zohydro against the advice of their own advisory committee, and their refusal to consult an advisory committee on other dangerous opioid approvals, including their decision to allow the use of OxyContin in children as young as 11 years old. Opioids are simply different from many types of drugs the FDA oversees. As I noted before, they have killed almost 200,000 people since 1999 and have ruined the lives of countless others. The FDA must be held accountable for their actions. Like our efforts to protect the public--particularly children--from the dangers of tobacco, the U.S. Congress must take action to ensure that the FDA does, in fact, do what it has promised to do and take the devastating public health impact of opiate addiction into account when approving new drugs. It is putting it on par with tobacco, that is all. In a mission statement, one has more responsibility than just passing it through as a business plan. My second amendment also relates to the critical role the FDA plays in addressing the opiate epidemic. It would require the FDA to seek the advice of its advisory committee before approving any new opiate medication. These are experts, scientists, people who know the makeup and composites of these chemicals and what they do to human beings. If the FDA approves a drug against the advice of the advisory committee-- that means if they do not take the recommendation by their own experts and they wish to put this drug on the market--the agency would be required to submit a report to us, the people's representatives, the Congress, justifying that decision. The approval will be delayed until the report is submitted. Tell us why you won't take the advice of your experts and why you even subvert and basically pay no attention. The FDA plays a critical role in addressing the opiate epidemic as the agency overseeing the approval of these drugs. Under the FDA's own rules, they are supposed to convene a committee of scientific experts when a matter is of significant public interest, highly controversial, or in need of a specific type of expertise. With 51 people dying every day in the country from an overdose of prescription opiates, it is clear that the approval of opiates meets every one of these standards and that the FDA should seek the counsel of its expert panel and adhere to its recommendations with regard to approving dangerously addictive opioids. Unfortunately, this hasn't happened. It truly hasn't happened. Let me give an example. It took us 3 years just to get rescheduled from a schedule III to a Schedule II all opiates--Zohydro, Vicodin. These are the most widely prescribed opiates. It took us 3 years, which what should have been a 3-week turnaround. The week after they even approved the taking down of these drugs from a schedule III to a schedule II, which took over 1 billion pills off the market, they came right back and they recommended a drug called Zohydro. This is a drug that their expert panel had basically advised 11 to 2 not to put on the market. They failed to seek their council's advice on the concerns with the safety of this drug. Since that time, three new extended-release opioid medications-- Targiniq, Hysingla, and Morphabond--have been approved without any advisory committee meeting at all. Let me give my reasoning on why I think this happened. There was so much pushback on Zohydro from the Governors, Senators, and Congress people for putting this high-powered drug on the market against the advice of their own council that they didn't want to go through that again, so basically they just skipped it altogether and brought these drugs right to market. They also approved OxyContin for use in children as young as 11, again without seeking the advice of a pediatric advisory committee. This is a dangerous precedent and must stop. I am encouraged that in the FDA's recent announcement on opioid approvals, the FDA has finally agreed that the approval of these powerful drugs must be subject to an advisory committee. I am very concerned, however, that the FDA will continue to exempt abuse- deterrent opioids from this process and has not promised to abide by the advice. They said they will take it under consideration. They are not bound to take the advice of the advisory committee. While abuse-deterrent formulations, which are harder to crush or liquify, have a role to play in reducing the impact of this epidemic, these drugs are no less addictive than traditional opiates. In addition, in the real world, we have seen these so-called abuse-deterrent properties easily overcome. The tragic HIV outbreak we saw in Scott County, IN, last year occurred after hundreds of people in that community shared needles to shoot up Opana. They used the same needle to shoot up Opana--something that should have not been possible if it were truly abuse-deterrent. This amendment would solidify the FDA's commitment to seek the advice of an advisory committee when approving opioid medications and would strengthen it by extending that commitment to all opioids and by holding the FDA accountable. The FDA does not listen to its own experts. This is such a reasonable request and such a reasonable amendment to protect all the people in all of our States. It is a commonsense measure that would ensure that the FDA is fully considering the public health impact and the many lives lost as a result of these dangerous opioid medications. Another amendment I have is on mandatory prescriber education. This epidemic is one that needs to be fought on all fronts, but most importantly, we need to fight it on the frontlines with prescribers, which is precisely what my third amendment seeks to do. It requires medical practitioners, our doctors--the people we trust--it basically requires them to receive training. You would think they are getting training on this now, but they are not. There is no specific training, going through school or at any other time, on the safe prescribing of opiates prior to receiving and renewing their DEA license to prescribe a controlled substance. That is all we are saying. This training must include information on safe opioid prescribing guidelines, the risks of overprescribing opioid medication, pain management, early detection of opiate addiction, and the treatment of opiate-dependent patients. This is something only the doctors can do. These are the people writing on their prescription pads, sending them to the pharmacists, and fulfilling all of our prescriptions. We are asking for them to have that type of required training when they get their DEA license and renew their DEA license. This must be fought on all fronts, but most importantly we need to fight it on the frontlines with the prescribers. According to the National Institutes of Health, more than 259 million prescriptions were written in 2012. Think about that--259 million prescriptions were written in 2012 just in the United States for opiate painkillers. That equals one bottle of pain pills for every adult in the United States of America. We are the most addicted country on planet Earth. With a population of less than 5 percent of us living in this great country of ours, we consume 80 percent of the opiates produced in the world. The other 6.7 billion people don't use what we use. Why? That is a 400- percent increase in the number of prescriptions since 1999. In a little over a decade, there has been a 400-percent increase, and we are pumping out more pills, thinking this is going to cure America. This is without a corresponding increase in reported pain. They are not complaining any more about pain; they are just getting more pills. But it has come with a corresponding 400-percent increase in overdose deaths. So if overdose deaths are related to the increase of pills on the market, don't you think we ought to do something about it? It is pretty simple. I have too many stories from my constituents that they receive significantly more pain medication than they need to treat their pain, and those extra pills increase the risk of addiction for individuals and are dangerous for society if diverted. Someone can get their teeth worked on, get their teeth extracted, and they will get 30 days of pain pills when they may only need them for 1 or 2 days. It is ridiculous. I hear from physicians themselves that they do not receive enough training. These are doctors telling us it is not in their basic education as they go through medical school--prescribing these drugs-- or even after they leave medical school. There is no continuing education demanded about this. Until we ensure that every prescriber has a strong understanding of the state of opiate prescribing practices and the very great risk of opiate addiction, abuse, and overdose deaths, we will continue to see too many people prescribed these dangerous drugs which can lead them down the tragic path of addiction. Finally, we must improve our consumer education efforts. My fourth amendment would establish consumer education grants through SAMHSA to raise awareness about the risks of opiate addiction and overdose. There are 2.1 million Americans addicted to opiates. Many of these individuals began the road to addiction with a seemingly innocent prescription and little or no warning about the danger from a physician. They weren't told they could be addicted. They weren't told they would be hooked and it would change their life forever. Or it began when a friend offered a pill that they thought couldn't be that dangerous because a doctor had given it to them: Here, I have got something that will help you. Try this. And they get started. There is simply too little understanding about the dangers of these drugs, and too many get sucked into opioid addiction because they don't understand the risk and because the people close to them don't know how to recognize the signs of addiction or know how to access the resources to help their loved ones. It is the silent killer. It is the one we all keep quiet--every one of us. Every one of us in America knows somebody--either in our immediate family, extended family or a close friend--who has been affected, but we say nothing. Use and abuse of prescription drugs cost the country an estimated $53.4 billion a year in lost productivity. These are people who can't function, who can't work, and are basically drawing off of their unemployment or off of their insurance. Medical costs and criminal justice costs--you name it. You talk to any law enforcement anywhere in the United States of America and they will all tell you a minimum of 80 percent of the crimes that are reported that they have to go and serve are drug related--80 percent. So the cost is probably even higher than that. This amendment provides $15 million a year to help prevent these costs in the first place. It makes sense. That is $15 million. OK, you are going to say: Oh, that is a lot of money. Let me just tell say that as a society we regularly invest in efforts to prevent unnecessary deaths. We already have done that, and we continue to do that. Thirty thousand people died in car accidents in 2013, and we invested $668 million in motor vehicle safety and accident prevention. That is more than $22,000 per death that we have invested trying to prevent people from getting killed in automobile accidents, driving safely, DUI, everything. With 28,000 people dying of prescription opioid or heroin overdose in 2014, this $15 million funding represents an investment of $500 per person for a life that we could save. We spend $22,000 trying to prevent accidents in automobiles. As to opiates, all we are asking for is a $500 investment to save their lives. We have to put our priorities where our values are, and we can do that. The grants that would be authorized under this amendment would help those on the frontlines of this terrible epidemic to provide their communities with the information they need to help stop the spread of opioid addiction and to help people seek treatment. This funding will better enable us to educate individuals about the dangers of opioid abuse. There are practices to prevent opioid abuse, including the safe disposal of unused medication and how to detect the warnings of early addiction. I would venture to say that most people do not know how to look at their children and know that there is a chance that they may get addicted or are getting addicted. It is sometimes too late. It will help us save lives by raising awareness about the dangers of prescription opioid medications to prevent opioid addiction in the first place and ensuring that loved ones know how to help when a friend or family member becomes addicted. This amendment that we are asking for, this amendment that I am asking for is one that really makes sense. If we can't educate the public, then we have little chance of ever curing this epidemic. We have had a lot of talk about the funds and how much money we are spending. We just had a final amendment that I would like to address, as there is a great need for funding to pay for substance abuse treatment. Well, I strongly agree with my colleagues who supported Senator Shaheen's amendment to provide $600 million in funding, which we desperately need to support Federal programs that work to prevent opioid abuse and provide much needed treatment. If you look at the amount of money it is costing now for incarceration, all the lost time, all of the drug-related crimes that have been committed, it would have been an investment well made, but I know there are people who believe differently. In 2014, 42,000 West Virginians, including 4,000 youths, sought treatment for illegal drug use but failed to receive it. There was no place to get it. In your State and my State people are looking. Sometimes they are looking for this, and there is no place to put them. If you have day courts or drug courts in your State, they will tell you: We have no place to put them. There is no place to get the treatment to cure a person who truly is looking for a cure. This is just unacceptable. There are people who recognize that they need it, and they beg for it. They have been turned away because there simply weren't enough facilities, beds or health care providers in their community. But we spend money every year building new prisons all over the country. We have a backlog, and we have an overcrowding prison population. We know from long experience that when a person asks for help, that is our opportunity. If we turn them away, they will never come back. They just don't when they are turned away. That is why I wish to introduce this amendment, and I would like a very vigorous discussion on it. We have tobacco, which we know is very dangerous and kills people. It is harmful, and we spend a lot of money trying to prevent people from using it and young people from starting to use it. We even tax it. We tax it so that basically we can deter the use of it. We have alcohol. We know alcohol can be very addictive and, basically, it ruins people's lives. We know that and we tax that. We have nothing on opioids--nothing. What we are asking for is consideration of a 1-cent fee on every milligram of opiates that are produced--one penny per milligram. This fee would be levied on the pharmaceutical company, and the money raised will be used to create a permanent funding stream to strengthen the substance abuse prevention and treatment block grant. I know so many people have taken a pledge: We are not going to pass any new taxes. I understand that. We are really at a crunch. We basically have cut back, and our military is struggling. Every part of a program that we think is near and dear to our States and to the people in our States is having trouble. I am not asking to take away from another one. I am asking that this one penny per milligram of opioids that are produced in this country would give us permanent funding to start having the treatment centers that we so desperately need. I don't know of any other way to do it in a more compassionate way. We do it for cigarettes; we do it for alcohol. We have opiates killing more than all of that. I am just asking for that dialog, that consideration. It could be something of a bipartisan movement, because this silent killer-- opiates--doesn't have a partisan home. It is not Democratic. It is not Republican. It is not Independent. It is killing Americans--all of us. The substance abuse prevention and treatment block grant goes to the States to pay for critical substance abuse treatment programs. The new funding raised, which is based on past opiate sales--I am basing it on past opiate sales--could be anywhere between $1.5 billion to $2 billion a year, and all the States will be able to participate. Every State would participate in these moneys that would be available. They could be used by States to establish new addiction treatment facilities, to improve access to drug courts, to operate support programs for recovering addicts, to care for babies born with neonatal abstinence syndrome or to meet any other treatment need that your State or my State might face. These treatments save lives and strengthened communities. We are losing a generation, a whole generation. Opioid producers have made billions of dollars selling their drugs over the past several decades. I am not here railing against the pharmaceuticals. They do a lot of good for our country and save a lot of lives too. This is one that doesn't, and this one has been proven that it is a killer. This amendment asks them to contribute a small portion of their profits to help pay for this treatment. Everyone says: They are going to pass it on. Don't worry; you will be paying more. This is one time, one penny--one penny a milligram. That is all we are asking. For the 2.1 million Americans who are addicted to their products, my amendment also provides exemptions. I am talking about the exemptions now because I know people are going to say: What about our veterans? What about those in severe chronic pain? What about those who are terminally ill? We have, basically, exemptions built into this amendment for those people, so they are not put into hardship, and for the neediest in our country. They are not going to be put in a hardship. This is a cost that if we look at it, I don't know of any other way to fix it. I really don't. I know people have taken pledges: We are not going to do this, not going to do that, not going to consider it. Well, you ought to consider the damage that is doing to America. I am not asking for any other program to be sacrificed at all. So I think this is responsible. This one penny. That is all I am asking for--one penny. I am pleased the Senate is addressing this epidemic. It is in a bipartisan way. We have the CARA package in front of us. I appreciate that, and I know we all have a great passion for trying to cure this. This is how we need to work to solve the major challenges in our country that face us. I am pleased to see we are going through regular order. We have amendments that we are able to put on and talk about. I think it is worthy to have these discussions. We must provide the critical resources needed, and I think we have a solution to that. I hope we can have that discussion. I hope all of us can have an adult discussion about how we save Americans, how we save our families, our children, and the next generations to come. I look forward to working with all of my colleagues and with you to see if there is a better way we can strengthen and make a piece of legislation better than what it is. I yield the floor.

Mr. MANCHIN

Mr. MANCHIN. Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. MANCHIN. Madam President, I rise today to speak in support of the Comprehensive Addiction and Recovery Act of 2015, also known as the CARA Act. Our country is facing a prescription drug epidemic, and today is a good step toward addressing this crisis. This is a crisis I have been dealing with since my days as Governor of the great State of West Virginia. Opioid abuse is not only ravaging my State, it is ravaging the country. Drug overdose deaths have soared by more than 700 percent since 1999. We lost 600 West Virginians to opioids last year alone. But our State is not unique; every day in our country, 51 Americans die from opioid abuse, and since 1999 we have lost almost 200,000 Americans to prescription opioid abuse. Think about that. That is more people than we have in any city in the State of West Virginia. This bill is an important first step. First of all, it will authorize $77.9 million in grant funding for prevention and recovery efforts. It will expand prevention and educational efforts--particularly aimed at teens, parents and other caretakers, and aging populations--to prevent the abuse of opioids and heroin and to promote treatment and recovery. It will expand the availability of naloxone to law enforcement agencies and other first responders to help in the reversal of overdoses to save lives. It will expand disposable sites for unwanted prescription medications to keep them out of the hands of our children and adolescents. It will launch an evidence-based opioid and heroin treatment and intervention program to expand best practices throughout the country. It will also strengthen prescription drug monitoring programs to help States monitor and track prescription drug diversion. While this bill is a good start and addresses critical problems, there is more that needs to be done. I will be offering several amendments to improve the bill by changing the FDA's mission, providing grants for consumer education, and requiring prescriber training. I firmly believe we need cultural change at the FDA, and that is why I introduced Changing the Culture of the FDA Act. It simply does exactly what it says--it changes that culture. My amendment to CARA, based on the Changing the Culture of the FDA Act, would amend the FDA's mission statement to include language that will require the agency to take into account the public health impact of the Nation's opioid epidemic when approving and regulating opioid medications and will hold the agency responsible for addressing the opioid epidemic. It is hard to believe that right now as all of these new drugs are coming to the market and all of these pharmaceutical manufacturers are producing this new product, basically the mission statement has never taken into account the impact of the opioid epidemic on the public's health in this Nation. Now that we see it is truly an epidemic, we think this is a much needed change, and hopefully it will be approved. This builds on and solidifies the FDA's recently stated goal to fundamentally reexamine the risk-benefit calculations for opioids and ensures that the agency considers the wider public health effects. We need a change in the culture of the FDA, but we also need to make sure the advocacy groups that fight this battle every day are armed with the resources they need to stem this tide. I am also submitting an amendment that will establish consumer education grants through the Substance Abuse and Mental Health Services Administration to raise awareness about the risk of opioid addiction and overdose. This epidemic is one that needs to be fought on all fronts, but most importantly, we need to fight it on the frontlines with the prescribers, those people whom we trust to get the training they need. That is why I will also submit an amendment that will require that medical practitioners receive the needed training on the safe prescribing of opioids prior to renewing their DEA registration to prescribe controlled substances. If you talk to any of our medical physicians throughout the country, they get very little training as far as the effects of these drugs, and we think it is well past time that they get the needed education, as well as continuing education, so that we can keep ahead of the prescriptions they are putting on the markets and basically keep them from harming people every day. According to the National Institutes of Health, in 2012, more than 250 million prescriptions were written in the United States for opioid painkillers. That equals one bottle of pain pills for every U.S. adult. Can you imagine one bottle of pain pills for every U.S. adult in this country? It is unbelievable. We are the most addictive Nation on Earth. Five percent of the population in the United States of America--there are 330 million of us and 700 billion humans on the planet Earth-- consumes 80 percent of the opioids in the world. It is just unheard of. Until we ensure that every prescriber has a strong understanding of safe opioid prescribing practices and the very great risk of opioid addiction, abuse, and overdose deaths, we will continue to see too many people prescribed too many of these dangerous drugs which can lead them down a tragic path, and that is why we need to educate people. There is one other subject I wanted to address, and I hope the FDA and this administration will look at it very seriously, and that is the professionals on advisory committees. When an opioid is coming to market, I believe and I believe a lot of Americans believe that this goes through a review process. These professionals basically are looking at this, and they make a recommendation as to whether this drug should be on the market, the need for this drug, and the effect this drug will have on people's lives. If they rule against this drug--and let's say they have an 11-to-2 ruling, such as Zohydro did--then the request for that drug to come to market should have to come before Congress. The FDA--the director and the staff--needs to basically come and explain to Congress why this potent drug needs to come on the market when basically their advisory committee and those people who are the professionals basically agree not to let it come to market. This is a conversation that has to be had. We have to make sure we understand why we are putting all of these products on the market and the effect they are going to have on the public. That is another topic we hope to address also as this bill comes to the floor. The bottom line is that I am pleased the Senate is working in a bipartisan manner. This is how we need to work to solve the major challenges our country faces. By working in a bipartisan way, we will have, as I understand, an open amendment process which is so needed and critical to move this legislation through. I appreciate that. I believe my amendments will strengthen this bill, but I also believe more needs to be done. We must provide the critical resources needed to stem this tide. I look forward to working with my colleagues to strengthen this bill and to begin to address this crisis head-on. This country has faced every crisis we have ever had, and we have overcome it. This is one we haven't attempted. For some reason, it is a silent killer--out of sight, out of mind. It will take all of us being Americans and basically using our faith that we have that we can fix these problems, to save Democrats, save Republicans, save Independents, and save everybody. This cannot be a partisan issue because I can tell my colleagues that opiates and the addiction of opiates have no partisan home. It is truly bipartisan. It attacks us all. I appreciate my colleagues, and I look forward to working with them to work through this important piece of legislation. I yield the floor. I suggest the absence of a quorum.

Mr. MANCHIN

Mr. MANCHIN. I ask unanimous consent to continue.

Mr. MANCHIN. I wish to speak on the nomination of the Food and Drug Administration, Dr. Robert Califf.

Mr. MANCHIN. Mr. President, are we in morning business?

Mr. MANCHIN. Thank you, Madam President. The FDA is supposed to be protecting public health and yet over 200,000 people have died and they have failed to put appropriate restrictions on these dangerous drugs to prevent overdose deaths. I want to know why there is one death from something such as ecoli and every head of lettuce is pulled from the shelves in ten different states but opioids have killed thousands of people and they are considered safe and effective? How can that be? When is the FDA going to put human life before the paychecks of Big Pharma? What will it take? A million deaths? We need an FDA commissioner that will protect the citizens of this country that is willing to take the overall best interest of public safety into consideration and not allow the pharmaceutical companies to have him in their back pockets. My son TJ had a lifelong dream of joining the military and fighting for his country. He would have given his life to protect and serve. He was one of the most patriotic young men and his country failed him. Please do the right thing. Please do not let one more mother get a knock on her door saying their child is gone and that they will never [ever] come home [again]. There is no greater pain than burying your child! My son, my precious child with the most beautiful blue eyes, caring and loving heart, died in part by the greed of big Pharma and-- Most importantly-- the carelessness of the FDA. It is time for change! Another story from Kentucky. This is in Northern Kentucky and this is Kimberly's story. My name is Kimberly Wright. I am a [mother from Northern Kentucky] who works in the trenches to save the lives of people in my Community. NKY was hit by a pill epidemic around 2000. That pill Epidemic has now turned into a Heroin Epidemic. Since 2013 the death toll continues to climb. In 2015 we have had 1,168 overdose reverses. We still await the number of deaths. Our entire system is on the verge of collapse--our Courts, Police, Children's Services, Jails. Our jails currently have 99% Heroin and Pill cases housed in the jails. Our Treatment system is seriously strained with not 1 new bed added in the last 10 years since this epidemic started. We are in a War in [Northern Kentucky]. Every day we wait to see how many died that day. We have people getting in their cars driving high on pills and Heroin wrecking into innocent people and killing them. This is the United States of America and this is a shame. We allow the FDA and Big Pharma to profit off the deaths of an entire generation of young people. We are in effect losing 2 jumbo jets full of kids every day in America due to Pills and Heroin. We need help. We are begging for help to stop this madness. Our American families are losing our children at an alarming rate to overprescribing Drs and Big Pharma. We beg you, please help us stop this. I lost my sister Alicia Cook on October 26, 2010, to an overdose. Alicia was a nurse with 2 young daughters. This Epidemic has no boundaries and it's in every community in the Country. Northern Kentucky has the highest rates of HEPC, surpassing the National Level, due to heroin and pills being injected. We have a high rate of homeless children due to their parents being dead or drug addicted with no end in sight. We have 52% of grandparents raising their grandchildren due to death and addiction. This is a nightmare for parents. When our children were born we could have never imagined this would be our life. You don't sleep at night from the anxiety of wondering if you are the next parent to get that call that your child has overdosed. It's like being in a constant panic attack. It's not normal to grieve the loss of a child who is alive, for they are truly lost. I [know lots of] parents who have lost their child and I can't imagine their pain and grief. I grieve for my addicted 26- year-old daughter who is in the fight of her life [because of] her Addiction. I watch her destroying herself every day. I don't want to join the mothers who have lost their child to this Epidemic. I know how I suffer now and I just can't go there. I will continue to fight for my community. Will you [please] join me? That is Arlene's story. Indiana is one of the States that has been hit so hard also. This is Danielle's story from Southern Indiana. My name is Danielle McCowan. I live in southern Indiana and work as a server. About 2 and a half years ago a customer by the name of Josh Harvey left me his number. At the time he told me he was living in Chicago for school. Little did I know he was in rehab there. Granted, I didn't know about his addiction for over a year because we hadn't stayed in constant contact. Over a year or so ago I found out about his heroin addiction. He still told me little about it. I do know it started out with prescription pills and later went to heroin when the pills became harder to get. He served a month in jail in Michigan for the entire month of this past July over a heroin related charge. He came home immediately after and overdosed that same weekend. Luckily, his dad saved him that time. Now he got enrolled in college and was going to an outpatient program doing better. Or so we all thought. School let out for break and I guess it all went downhill. He came to me on November the 4th telling me he had used a couple of times and wanted my advice. I suggested an in-patient program. He went to Wellstone after he left my house. He sat for several hours and finally was given a room. I went and checked on him 2 different times while he waited to make sure he was there. Thursday I didn't receive any calls. Friday nothing either. Then Saturday morning, the 7th of November, his mother called me to break my heart. He had passed away that Friday, the 6th, over in Louisville and didn't know who to contact until that Saturday morning, I guess. He had checked himself out of Wellstone, broke into his house, took his Xbox which he later either pawned or traded for heroin. Never in a million years did I think I'd become close to anybody addicted to heroin. It doesn't discriminate. It can get ahold of any and everybody. Never in my life have I been so depressed or heartbroken. All I want is his story shared. He was my happy ending gone away too soon. They continue. They continue on, these stories, the heartaches and the lives destroyed, lives changed. Few too many lives are saved. Massachusetts. As the Presiding Officer knows, Senator Markey has been working with me very closely and all of us on this horrible epidemic that we have. This is Sara's story. She is from Amherst, MA. My nuclear family is middle class or the working poor, but it is blended in that I was raised by my mother and step-dad, but my bio father's side of the family would be considered well-off. Heroin first came to my radar after my brother Donny became addicted to pain pills after surgery, and heroin followed suit after RX's stopped. Then it seemed like it was everywhere around me: my nephew, my niece. Then we lost my cousin Cory, who passed in a sober house for his addiction to alcohol, along with a needle and an empty bag next to him. Cory is an example of a young man institutionalized by multiple incarcerations and just when he would try to lift himself up, in he would go again. He was trying to get clean for his girlfriend and unborn child when he passed away, and he was happy, thinking he was getting better. Living with someone close who struggles and then multiply that by two, and adolescence, young adulthood mixed in, and you have my descent as an empathetic aunt who felt powerless to change anything. Then the bottom dropped out. My cousin, John Ahern, passed at the end of August after a long period of recovery alone in the woods. It didn't matter he came from privilege or was the nicest person I had every known in my life for so long. He leaves behind three loving sons. They both couldn't access the help they needed at various stages, including recovery, and died alone. It is my mission to stand up for them and the young people like my niece who began her struggle at 14, and now approaching 18 has some clean time. There are no support programs in my community for this age group, and especially for non-White young people like my niece and nephew. They are both of Latino descent. Please do something. People are begging us everywhere in this country to help them, and basically it starts with treating this as an illness and not as a crime. It starts also with having clinics, having basic places where we can serve them and help them get clean. They cannot do it by themselves, and they are the first to tell you. The stories I am reading here exemplify that so well. I have a Florida story here, and Florida has also been ravaged. Florida was a problem that we had in West Virginia because of the pill mills there. People would take the bus down or they could take a cheap flight down to Florida, buy all the pills they could and come back. Florida has been very helpful in the last years trying to stop the pill epidemic. This is Janet from Fort Lauderdale. Dear Senator Manchin. I appreciate you taking the time to stop the appointment of Dr. Califf from becoming the FDA commissioner. I founded STOPPnow--Stop the Organized Pill Pushers now--due to all the drug-addicted babies I was caring for as a neonatal intensive care nurse at a children's hospital in Broward County, FL. We started holding protests in front of the 150 pill mills that were in Broward County alone. Many parents came out to protest with us. Parents from all over the country contacted us as well. Too many parents are crying themselves to sleep over the loss of their child. At first, there were no consequences for either the clinic owner or the doctor. Then they started arresting the doctors for money laundering. Our State's attorney has called the doctors drug dealers in white coats. The Board of Medicine is not protecting the public by allowing high-prescribing doctors to keep their license. Therefore, the plight of the drug-addicted babies and the devastation to the families continues to rise. When one clinic owner was arrested, he was earning $150,000 a day. I repeat, $150,000 a day. Not one doctor in that clinic to date has lost his license or his practice. We only have the judicial system helping to alleviate this in Florida. Doctors are now being charged with first-degree murder. It would be kinder for a doctor to lose his license than to sit in a courtroom at their own murder trial. We have been unsuccessful in our efforts for lawmakers to mandate that prescribers use the prescription drug monitoring program in Florida. Yet in this environment, there is a bill passing through the committees allowing nurse practitioners and physician assistants to prescribe narcotics without a doctor signing off on the order. I would support this bill if they included the mandate. And, of course, the FDA approved that children as young as 11 years old can be prescribed OxyContin. We definitely need an investigation. Madam President, as you can see, these are problems that we have all over the country. This is not just your State and not just my State. I know it is hard. They say we need someone in there, so let's just go ahead and confirm Dr. Califf. Dr. Califf is an honorable man. He is still there. He is going to be there. He has been there for 1 year. In the 1 year that he has been there, we have basically put more opiate drugs on the market without even going through a clinical overview. If that change were going to come, it would have come by now. I am sure he could have had input, and I would hope that he would. Dr. Califf has called a lot of our colleagues and said that these changes will be coming. This Senator will tell you the changes they recommended when they said they were going to make changes. They said: We are going to make sure that we are going to start listening to our staff and people who are reviewing these drugs. They are going to listen to them, but there is no mandate that they will have to follow. This Senator has a piece of legislation that the Presiding Officer coauthored, and I appreciate that very much. Basically what we are saying is this: When you have your advisory committee--and every drug must go through an advisory committee's opinion, and if they recommend as they did with Zohydro to not let it go on the market, that cannot be bypassed, neglected, or pushed aside. Our bill would basically state that they must bring it to the people's representatives in Congress and state why it is so very important for them to bring this new high- powered drug to the market--as if we don't have enough. The United States has 5 percent of the world's population but consumes 80 percent of these addictive opiate drugs. Something is wrong. Something must change. I thank the Presiding Officer for allowing me to be able to read the letters of people who have been affected by this all over this great country in all of our States. I know we feel the pain, and we are going to try to make these changes and make sure this agency will do what it is supposed to do. I yield the floor.

Mr. MANCHIN. Mr. President, I believe the FDA needs new leadership, a new focus and a new culture, and Dr. Robert Califf's past involvement with the pharmaceutical industry reflects that he will not be this person. He will not have the impact or leadership capabilities the Nation needs to stem the tide of the opioid crisis we have all over this country, even in your great State of Oklahoma and my State of West Virginia, which has been ravaged by this. I would like to put this in context for a little bit. He has been there over a year--a good man. I am not speaking about his ability, his honesty, his integrity, his education, his background, and all the good work he has done. But he has been there for a year, and for the past 20 years Dr. Califf basically has come from the institutional research side, from education, and with that, his support has come from the pharmaceutical industries, those that are putting opioids on the market. I just feel it would be hard, human naturewise, for him to change and rule to keep these products from coming onto the market. So to put this in context, this is not personally about Dr. Califf. This is about the culture he comes from and the year he has been there as the No. 2 man and what has happened during that period of time. Let me go over some things. Over the last decade, the FDA has approved new drugs at historically high rates. In 2008, companies filing applications to sell never-before-marketed drugs were denied 66 percent of the time. They were denied 66 percent of the time. Yet between the beginning of 2015 and August of 2015, the FDA rejected only 3 uses for new chemical entities and approved 25. That is an approval rate of 89 percent. Now, tell me how in 7 short years that culture changed to where anything and everything coming at us was passed through, when we have already become the most addicted country on Earth. If one looks at new drugs and not the use of drugs, they have rejected only 1 and approved 23. That is a 96-percent approval rate in 2015. So of the new drugs that came to the market, only 1 was rejected--a 96-percent approval rate. In 2008, the FDA's approval of new marketing claims for existing drugs was 56 percent. In the first 8 months of 2015, it was 88 percent. This includes approving OxyContin for children as young as 11. The FDA's 2013 approval of Zohydro drew widespread concern. All of us were outraged when we heard this new drug came on the market. To put another time period in context, I had worked for 3 years to try to get all opioids from a schedule III to a schedule II so doctors could prescribe only for 30 days. You had to go back and see your doctor. Up until that time, Vicodin and Lortab--the two most widely prescribed opioids--were schedule III. That means you could get a 90- day prescription and then call in to get it refilled. They were going out like M&Ms. We were able to do that, and no sooner did we get that done--and it took 3 years, when it should have been 3 weeks. Within the same week that all opioids got to us from a schedule III to a schedule II, they approved a new drug called Zohydro, which was 10 times more powerful than Vicodin or Lortab--much more powerful. That approval was done against their advisory committee 11 to 2. That means 13 experts evaluated this drug and said: It is not needed, too powerful, don't do it. Guess what, they did it anyway. Now they are saying that they are not going to pay attention to the advisory committee. Not only did they say they are not going to pay attention to the advisory committee, but we have had the decision on OxyContin being given to 11-year-old children; we have had the two new drugs that came out in 2014 after Zohydro and the pushback from Senators representing our respective States; they had a new drug called Targiniq, which is an extended-release OxyContin product, and Hysingla, which is an extended-release hydrocodone product. So there were three new decisions made, with two new powerful opioids coming to the market and the decision that OxyContin would be given to 11-year-olds. That was done without any review from the advisory committee. They got so much pushback from Zohydro, they said: We are not going down this path again. We will just not have anybody review it. We will just go ahead and do it. If you believe that is a culture that will protect the welfare and well-being of our citizens in our States all through this great country of ours, then I am sorry because I don't. I am sorry, but that is why I have been so passionate. I have more people dying of legal prescription drug abuse than anything else in the State of West Virginia. More people die. It is ravaging families. I have personal letters I will read, and they will tear your heart out with what is happening and how this grips and tears people apart. It tears communities apart. Every law enforcement agency in America will tell you--no matter what town they are in, what county they are in, or what State they are in--that over 80 percent and upward of 95 percent of all crimes committed are drug related, are some sort of drug related. There is not one of us right now in this beautiful Senate Chamber that doesn't know somebody in our immediate family or Senate family that hasn't been affected by drugs, either prescription legal drugs or illegal drugs. It is awful. It is an epidemic. I believe the FDA must break its cozy relationship with the pharmaceutical industry and instead start a relationship with the millions of Americans. I have said that I am going to fight against the FDA protecting a business plan and hopefully the culture will change, and they will start protecting America and the plan of families and citizens of this great country to have a healthy lifestyle. It is because of this belief that I am urging my colleagues to vote against the confirmation of Dr. Robert Califf as the director of the Food and Drug Administration. He will still be there and still be a valuable person. He is just not that person with the passion to change the culture in this important agency. We have let this sleeping giant go for far too long. My office has been absolutely flooded, Mr. President, with stories from West Virginians--but I have received them from all over the country--who want their voices to be heard. They say: Please use my name. I am not ashamed. We have been hiding too long. I have watched too many people's lives be destroyed. So today I will read letters not only from West Virginians but also people across this great country of ours that have been impacted by the opioid abuse epidemic. I urge my colleagues to listen to these letters from their States and stories from my State about these drugs before confirming Dr. Califf, and in all good conscience make that decision tomorrow when we vote. Do you really believe he can bring the changes needed and not just say: Well, we have to have somebody there. He is already there. He will do a good job where he is; he is just not going to be able to kick them and shake them up and say we are not going down this path any more. There are some good people. We have made some recommendations of some good people who would bring the cultural changes that need to be brought. I am going to read first about a young lady from Southern West Virginia. Her name is Chelsea. This is her story. As a recovering addict, I have watched myself, my friends, and loved ones suffer from this horrible thing we call addiction. As I watch all these people now suffering, I know they had no idea what they were getting themselves into, and neither did I. Whether it be for pain or just simply hanging with the wrong people like I did, we all have one thing in common, we chose to do drugs for the first time. Someone made a decision to do drugs for the first time. Growing up, I can honestly say I had what most people would call a normal childhood. Chelsea comes from an upper socioeconomic family in Southern West Virginia. She continues: I was raised by two hardworking parents who would and will still do anything for me. I was a gymnast and a cheerleader for most of my life and went to church every Wednesday and Sunday. My dad was even the Mayor of Madison at one point. But even being raised up in a good home did not stop me from doing drugs. So this has no socioeconomic bearing. It does not. It is not a partisan issue. Whether you are a Democrat or Republican, it makes no difference. Rich or poor makes no difference. Chelsea continues: I can still remember the first time I heard about someone getting high. I was in the 6th grade and became friends with a girl whose parents got high themselves. We would walk about the playground and she would talk of these things called ``drugs.'' As she talked day in and day out about how getting high made her feel, it made me start to wonder what this thing called ``getting high'' was really about. Now, mind you, I am talking about a 12-year-old girl. She was just 12 years old. I can remember thinking how cool I thought it was that her parents had done drugs with her and would party with her. So another friend of hers, also 12 years old, had parents who were doing drugs with her and would party with her. Chelsea continues: One weekend I went to her house to stay the night and this was the first time I had gotten high. We smoked some pot, drank some alcohol, and I was turned on to my first pill around the age of 12. From this day forward, my life would forever be changed. From the ages twelve to fifteen I partied some on the weekends and sometimes during the week, but as time went on my addiction and tolerance grew more and more. By this time, I was doing more pills because I had access to them. Between stealing Lortabs off my dad, to hanging with that girl so we could get high with her dad, to buying pills off the local drug dealer on the street, I had moved from doing them every now and then to every day. I would stay a lot of weekends at this girl's house just to get high because my parents would never have done that nor did they know I was doing it. By sixteen my life took another turn. My grandmother, who I called Nana, had taken care of me most of my life while my mother worked. She was diagnosed with lung cancer two years prior. In the last days of her life, I would visit her in the hospital and she would tell me how proud she was of me and how I was her little model. I had also met a very special guy by the name of J.R. a few months before this who I spent a lot of time with. On July 18, 2003, my Nana passed away. On the day of her wake, J.R. took me out to dinner, and on the way home he asked me to go meet his dad. I explained to him I could not and that my grandma's funeral was the next day. He dropped me off that night, kissed me good-bye, and that was the last time I ever heard from J.R. Twenty minutes after he left me, he wrecked and died. I felt like my heart had been ripped out of my chest. The day of his funeral is the next time I met the love of my life that would soon try to destroy my life. It was called OxyContin. I fell in love immediately with OxyContin. It took all of my cares and worries away, and from that moment on all I wanted to do was be numb. As the years passed, my drug addiction grew worse. I was not only doing pain pills, I was now experimenting with all kinds of other things. I can still remember my senior week in high school. While everyone was excited about going to the beach, I had to make sure I had enough drugs to go and not be sick. I took Roxy's and Oxy's, pretty much anything I could get my hands on, and eight balls of cocaine. By this time in my life I didn't care about anything. It never once had crossed my mind that if I got caught with all of that I could go to jail. I was just worried about my next high. The following months were the same. I was doing anything I could to get my hands on drugs, from pain pills to cocaine to meth. I did not care as long as I was high. I was hanging around with people who were as sick as I was and places that I look back now that I would not even take my dog. At 19 I met a guy who would fuel my drug addiction even more. He was 40 years old and dealt OxyContin. At this point I could not afford my habit, so I did what I had to do. I started seeing my drug dealer. My life soon went from bad to worse. I had OxyContin 80s any time I wanted them, and at the time I thought life can't get any better than this. When you are doing eight to ten OxyContin 80s a day, you will do whatever it takes to get them. At this point I was turned on to heroin. Heroin would have taken my life if it hadn't scared me so much. The high from heroin is so intense that anyone who had done it would have fallen in love. But, actually, it scared the life out of me. As time passed and I wasn't getting high like I wanted to anymore from snorting OxyContin, I decided to start shooting up. That is one thing I never thought I would do is shoot up. I always told myself that people who shot up were the homeless people on the streets, complete and utter trash. Now here I was sticking a needle in my arm to get what I wanted. And to be honest, I thought life was bad before. It just got a whole lot worse. The life I was and the life that I knew was gone, and OxyContin was completely ruling my life now. OxyContin is a legal drug made by a legal pharmaceutical that knew exactly the effects this would have when they put this on the market over 20 years ago. She said: What stood before everyone was pure addiction. I had started stealing off of everyone by now and didn't care who I hurt. People's priceless possessions that meant so much to them meant nothing to me. All I'd seen was my next fix. That's all I could see. People were bringing me stolen stuff and I was taking it to the nearest pawn shop or my drug dealer. I had no shame. I had needle marks all up and down my arms, and I would lie to my family about how they got there. It was like I had no conscience, or, better yet, my addiction was my conscience. Eventually I got caught stealing and was charged with 17 different felonies and one misdemeanor. This still did not slow me down even though I was looking at two to 20 years in prison. Nothing scared me more than being sick from the drugs. On September 29, 2008, I was called in for a random drug test and failed because I had shot up OxyContin the day before. At the courthouse they handcuffed me and shackled me and sent me to Southwestern Regional Jail where I did a total of 10 days. As I sat there in that jail cell and cried, I thought a pill could not be worth two to 20 years of my life, and I hit my knees and prayed to God that if He brought me out of that jail cell, that I would never, ever, ever touch drugs again. The Lord answered my prayer and the judge gave me the choice to stay in jail or go to the Life Center of Galax, in Galax, Virginia. I chose to go to rehab. I completed the 30-day program and came back and did Thomas Memorial's intense outpatient program for 6 more weeks. Once I got home I was sentenced to two to 20 years, but they suspended my sentence. I went through drug court and completed it. I was the third person to ever graduate from the Lincoln County Drug Court. I also had to do 14 more days in jail, 6 months of home confinement, and 4 years' probation. I can honestly say that going to jail and rehab saved my life. If I hadn't have been put in jail, I would probably be 6 feet in the ground just like a lot of my friends that I had to bury. All of these things combined gave me something I hold very dear to my heart. My recovery. Recovery has not only given my life back. It has given me a chance to be a daughter, a sister, a wife, and hopefully a mother someday, a productive member of society, a good friend, but most of all, my recovery has given me a chance to be the voice of the sick and suffering addicts who lay in bed at night wondering if there is a way out. I enjoy giving people hope and showing them that treatment does work. I am living proof that if you work the program of recovery, it will work for you. Since that day I had found myself sitting in that jail cell with no hope and my life completely consumed by my addiction, my life has changed for the better. I have graduated with an Associate's Degree in applied science from Southern West Virginia Community Technical College. I went on to get my Bachelor's degree in the arts of psychology from West Virginia State University, and now I am currently working on my Masters of Social Work degree at Concord University, and I will graduate with that degree in May. I have also been able to go to various schools, drug courts, and different places around the state to tell my story of addiction from where I was then to where I am now. I have also had the pleasure of working with a great group of people who are trying to get a sober living home open in Danville, West Virginia called the Hero House. I can tell you, she is so passionate about getting this Hero House so she can help other people. Anybody listening who wants to help Chelsea in Danville, WV, with the Hero House, please do so or contact my office. Now, with all this being said, I don't tell my story to get praise. I tell my story because there is a son, a daughter, a husband, a father, a wife, and many, many other people out there addicted to drugs and they do not see a light at the end of the tunnel. When you are in active addiction, that light is so dim and a lot of times people think they are going to die from this horrible disease. But I am here to show people that you don't have to die. You don't have to let that horrible addiction win. You can step out and take your life back, because I am here to tell you that if you don't, if you don't, your addiction is going to take you to your grave. Drugs do not discriminate. They know no good, no bad, no rich, no poor. There are so many people out there who suffer from this because there is little to no treatment. By the grace of God I was sent to rehab and given a second chance. I still have the horrible reminders every day of the things I did to my family, to my body, and, most of all, to my self-esteem. I have the track marks after being 7 years sober that constantly remind me of the life I once lived. I have a poor self-image because of the men I chose to give myself to just to get a pill, and the damage I did to my family because I had no cares in the world. One day I hope there is enough treatment to help the addicts who want help. People need to be given a second chance and shown there is a better way of life than to do drugs. I have another story called Tami's story, but I know Chelsea. I know this girl. She is impressive. She said: Please tell my story, I want people to know. No one could come from a finer family than I came from. No one can go lower than I have gone, and no one but by the grace of God could be saved like I was. When we hear these stories--and all she is saying is there is no treatment. She was lucky. She found a treatment center. Somehow we have to come to grips with this. We have a tax on tobacco because we know it is harmful and we have to cure people of the disease. We have a tax on alcohol. We have no fee whatsoever on opiates--none--and it is destroying lives like nothing else that has ever happened in this country. We need to make people conscious of this, and we need to have an FDA that is compassionate, but not only that, is committed to the change that needs to be made in our culture. I want to read Tami's story, from West Virginia. That is in the northern panhandle. Chelsea was way down in the southern part of our State of West Virginia. We have 2 adult children suffering from substance use disorder. Our son entered the military while in college. He was sent to Iraq right after 9/11, December 27, 2001. He experienced things that he never talked about, celebrated his 21st birthday there, and returned home. He was not a saint when he went to war. He had a juvenile past of drinking. Back then we thought he was a typical teenager acting out. When he returned, he suffered PTSD, as many do, and went to the VA hospital for treatment. He was put on cocktail after cocktail of medications. We all know this. We all know that basically these brave men and women who are willing to risk their lives and sacrifice their lives for us--in order to treat their pain, we think, just give them a prescription, and they are able to get anything and everything. That is what they are talking about when he was put on cocktail after cocktail of medications--was this his starting point of the spiral into addiction? I believe his addiction to opioids, benzoids, and amphetamines started then. I know that he spiraled from that point on. He lost his marriage, he didn't see his son, he bounced from drugs to drugs to drugs. He obtained several DUIs, and time after time he walked away, no offer of help, no sentencing. He bounced, married again. She was addicted to heroin. He bounced again, was in and out of our house. Unfortunately, we always gave him a safe place to land. She said: ``Unfortunately,''--not fortunately but unfortunately--``we always gave him a safe place to land.'' The last time I saw him is when I called the police on him. I discovered that him and his girlfriend, with two small children, who had been living in our house for four months were using and selling drugs. I found out he was recently incarcerated for drug traffic and sent to a correctional rehabilitation facility. Our daughter was an athlete all through school. She received injury after injury, and at 18 started seeing specialists for back pain. That was in 2004. They prescribed opiates. I never saw the addiction coming. She lost her best friend since first grade that year to a drunk driving accident. She went to counseling. More prescriptions. She appeared fine, gave birth to a beautiful baby boy, and then because of back pain more pain prescriptions were given. I realized she had a problem when she was pregnant with her second child and was stepped down to Vicodin while pregnant. Vicodin while pregnant. After his birth, we started her first rehab experience. She returned to the father of her children sober. She relapsed and began snorting heroin. At this time she was living in Ohio and we were unaware of her relapse. We found out when her mother-in-law went to court and took her children. That was one of the worst days of all of our lives. We immediately picked her up, brought her back to West Virginia, and into treatment. Fast forward. Thousands of dollars later on attorneys, doctors, rehab, she returns to Ohio to try to obtain her children. Relapsed. She began shooting heroin and then arrested. We let her sit in jail and picked her up on her release. Charges were dismissed. Back to West Virginia she comes, hospitalized for a week and rehab again. She has now been in recovery for 13 months. She fell in love with a nice, drug-free man, moved to Ohio to try to obtain custody of her children back, and is six months pregnant. One thing I can say is my daughter was always a good mother. Even while on active addiction, she worked and took care of them. As you can tell, both of our children became addicted to prescription drugs first. . . And they tell me this is exactly how it starts. It starts at a very young age. Recreational marijuana, prescription drugs out of your parents' medicine cabinet, taking it to school, being the cool kid in school, sharing those drugs, then you begin using them, then you sell them. This is how it starts, and it leads to obtaining street drugs to feed their addiction. So it goes from occasional to recreational to addiction to feeding that addiction. This is a condensed version of course. As with any family dealing with addiction, it does not show the tears, the hurt, the financial breakdown put on the family; (we are broke). Literally and figuratively. She says: I want to thank you for listening. Doctors keep prescribing pills, and they will tell you that they have had very little training in this area. As they go through all of their medical schools and advanced training, they get very little training on the effects these drugs have on human beings and the addiction. We took 1 billion pills off the market when we went from 90 days to 30 days of Vicodin and Lortab. We took that many pills off the market. That means 30 days. I have people in my office or in their families--and I know the Presiding Officer does as well--who will go to the doctor for something where they may need pain relief for 1 or 2 days. Do you know what they get? They automatically get enough pills for 30 days. That is the path of least resistance. It is legal, they can do it, and the doctor will write a 30-day prescription. We are working on a bill that will be coming to the floor. We need to make a lot of changes to that bill, but most importantly, we need to make sure we have an agency in the Federal Government of the United States of America that is fighting to protect every American. And it is not a business plan that we have to adhere to, not at all. These are good companies. They are legal pharmaceutical companies. They do an awful lot of good. I challenge every one of them that is listening to what we are talking about right now to give us pain relief without addiction to opioids. Do something. Break through the chemistry or something. It has to be there. We have been able to solve every other epidemic. We have been able to cure epidemics and pandemics, and now we have one that has been ravaging our country for almost 30 years. I have Samantha's story. She says: Hello. My name is Samantha Holbrooke. She wants you to know her name. I am from Fayette County, WV. I am a 28-year-old female. I have been an addict for the past 6 years. This letter is to explain to you how addiction has affected my life. It is also to express my view on drugs and what it is doing to our society. I first started drugs when I was 13 years old. I was a recreational marijuana user. My mother was an alcoholic and a drug addict. My father was not in the home or involved in my life. Unfortunately, that is true for many people around this country. My mother would allow me to drink with her and go to bars. I was often her designated driver, but I was only 13 years old. I got in my first and only bar fight at 13. It was with a 24-year-old woman. She thought I was coming on to her boyfriend. In reality, we were smoking weed, not trying to hook up. When I was 19, my oldest sister and mother introduced me to hydrocodone, Ritalin, Xanax, and Percocet. My sister and mother had no income; I did. By getting me on pills, they were able to get free pills by charging me to get them for them. By the time I was 22, I think I was snorting Oxycodone. Oxycodone is made in a single source, which is a powder form that is compressed. They would break it down, crush it, and snort it to get the quicker high. That became my drug of choice. I eventually got in with a doctor who was pretty much a pill mill. We know we have them all over this country. He wrote me a prescription for Xanax and Oxycodone. I got even more strung out on those two. As a result of using drugs, I now have memory problems, concentration problems, and the list goes on and on. I lost about 30 pounds. I lost my job. I lost my home. I lost my child. I lost my fiance to suicide. He was drunk when he shot himself in the head. I believe that had he not been drinking, he wouldn't have taken his own life. As a result of these life-changing events, I became severely depressed. I then took the wrong road and began to use drugs intravenously. I started lying and stealing. This led me to gain two felony charges and several other misdemeanors. I went to jail and prison and spent 2\1/2\ years locked up. I am now on DRC because I am on parole and had a relapse, which led to several bad decisions, and now I am paying the consequences. I am now in recovery. I am a recovering addict. I joined Narcotics Anonymous and Alcoholics Anonymous. The classes and programming in prison helped me to think better. I now analyze a situation before making a decision. This is my story. Prescription drugs and all drugs have ruined a large percentage of the citizens of West Virginia's lives. I am now in full control of my life again, thank the Lord. This story is anonymous, but they wanted to share it with us. I grew up in a nice home. My grandfather was a pastor. My dad grew up in church. My family went to church every Sunday. We had a nice house. We had nice cars. My mom didn't have to work, and my dad took very good care of us. My dad had surgery, a common surgery to remove several large veins in his legs. This is where his addiction began. This is where he found his unlimited supply of numbness. I was in middle school, and this is when I remember things being different. Things were changing. My dad stayed out with his friends a lot. He wasn't home for dinner anymore. When he was home, he was lying down sleepy and always said silly things. I would stay up late at night until he would get home, only to hear my mom and dad fighting, screaming, and my mom crying. Eventually I hated to hear the garage door open because I didn't want him to come home. Before my dad would take me to school, standing in his business suit with his briefcase, he would scarf down pills out of a little orange bottle. He would tip it back like he was eating a box of Nerds. I didn't know any better. My naive, my innocent mind didn't know what was happening. I couldn't comprehend that a doctor could be his drug dealer! They couldn't comprehend that because we have been taught to trust doctors. Things got worse. I started finding bottles of liquor and cans of beer hidden, and I passed it off. The 3 empty beers in the back of his company car: Oh, they must be his ``friends''. No one in our family drinks, definitely not my dad. I remember whole vacations, weekend trips, and afternoons ruined by his addiction. Mad fits of rage until one day my mom stood up and couldn't take it anymore. My dad got the help he needed, but how did he get the help? In hiding, in private--a local rehab facility. He was on a business trip. Our culture has stigmatized a group of people--a group of people who transcend race, status, gender--at the expense of their lives. This is a hidden killer. Drug abuse and drug addiction are hidden killers. So many of us have people in our families or close friends who don't want to talk about it. They are ashamed, and so it gets covered up and hidden away. As a result, we don't bring people out, let them know the effects, and cure them. She says: My dad was hurting. No, not from the wounds on his legs when he had his surgery but from depression and bipolar disorder. These are the roots of his addiction. They go hand in hand. When will we see this? When will we stop seeing addicts as a problem and see them as human beings and hurting? For the last 20 to 30 years, I have been in public life, and the Presiding Officer has been in public life a good bit. I always thought that anybody who fools with drugs is a criminal and should be put in jail. We have done that, and it hasn't solved a thing. It has gotten a lot worse. We have to rethink this issue. This is not a crime. Addiction is basically an illness. It needs to have a cure, and treatment is that cure. We have to face that. Senate Republicans and Democrats are looking at how to fix the sentencing guidelines, and I think it is encouraging and healthy for us to have these discussions. She says: Is it a selfish sickness? Of course it is. But how can we help them see the light when we push them aside? Because ``they asked for it?'' Just like a lady with skin cancer ``asked for it'' because she laid in a tanning bed? What if we treated addicts with the same compassion that we treat cancer patients? My father has been clean for almost a decade, and the demons of his addiction still haunt us all. No, we weren't homeless, nor did we have to face a death to be completely broken by this horrible epidemic, but I had a zombie for a father for my adolescence. I missed my childhood, years that we can never get back, memories that will never be erased, all because of a little orange pill bottle chased and hidden with a brown paper bag. Luckily, my story ends with a happy ending. I still have my dad. My story hasn't ended up the way so many do every day, like my two friends who didn't get help in time and passed away. I have stories from all over the country, and they are pathetic. I have a couple more I can read from West Virginia. I will go to different States. This is Erica's story. She says: Hello, My name is Erica and I am an addict. And I say that with great pride as I celebrated 10 years of recovery in November of 2015. I began using drugs here in West Virginia at the ripe age of 13. Thirteen seems to be that magic--adolescence. We are coming into adolescence. We are willing to experiment. We think we are invincible. We think nothing can harm us. Prescription drugs were easily accessible at that age and opened the door to 11 years of anguish, desperation, jails, and dirty needles. I came from a stable, drug- and alcohol- free home, but I was able to gain access to prescription drugs from my peers and my local middle school and high school on a daily basis. As my disease progressed, I dropped out of high school my freshman year and continued to put myself and family through years of pain and suffering. I attempted drug replacement therapy to control my opioid addiction, but that was only a temporary solution, and I eventually returned to drugs. Finally, I found myself in the court system and facing felony drug charges. It was then that I was able to find freedom through a 12-step fellowship. Today I can say I am a cum laude graduate of Marshall University, fully employed, homeowner, wife, and the mother of two wonderful West Virginia boys. I pray my children don't follow the path that, not only myself, but many of my West Virginians fall into. The disease of addiction is progressive and fatal if not treated or prevented. Here in West Virginia, we are leading the Nation in drug overdoses. And where I live in Cabell County, we have had over 900 overdoses in just the year of 2015. As a mother, I must trust our leaders to make responsible choices to help us seek solutions, gain back our communities, and save our children from following the same deadly path. I know the FDA was so proud that they came out with some new guidelines, and they said now they are going to start paying attention to the advisory committees. They didn't say they would adhere to their recommendations; they would just start paying attention to them. Also, the CDC--the Centers for Disease Control--put out some guidelines of how we should be prescribing, the knowledge we should have, how we should be administering, and what we should be doing to curb this drug abuse. And guess which agency fought against that and put it on delay? The FDA. The only thing I ask all of my colleagues to do is to please consider--just send a message with the vote you make tomorrow. It is not about the doctor at all. It is not about the person before us. It is about getting an advocate who will make a real change and make sure we fight this war. This story is another anonymous story: My brother is in his early 20s and was hired at the local plant that employs the majority of the county. He was injured on the job, saw his doctor, and was prescribed Lortab long term. Lortab, as I said before, is a schedule III, 90 days. You can keep calling it in, calling it in, and calling it in. As the effects from this started to wane, he was prescribed Xanax, Klonopin, and a variety of other prescription medicines. He then lost his good-paying job but found other work at a lower pay after almost a year of unemployment. This prescription med addiction continued for years, and once laws finally cracked down on prescribing narcotics, it left him unable to get all the medicines he had previously been prescribed. Once it became too expensive to buy them on the street, he turned to heroin. My fun-loving brother who was always at family functions, loved to be around his nieces and nephews, totally disappeared. I suspected that something more serious was going on, but he wouldn't answer calls or texts. In August, I hadn't seen him in several months. We have always been close. This was very unusual. I sent him a novel of a text since he wouldn't take my phone calls confronting him over the rumors that I had heard of his heroin use. He denied it. A few short weeks later, I got a call from my mother that he was transported to the hospital by ambulance but discharged a few hours later for chest pain. He later told us he had gotten a bad batch of heroin and was certain he was dying. He told the EMS he had used that morning, as well as hospital staff. I still to this day don't understand how someone can come in suffering from an overdose and be discharged a few hours later. People don't have knowledge. They are not being trained in this horrible epidemic that we have in this country. NOTHING was mentioned to him about treatment or rehab and he was treated as a lesser person. I was worried before, but after this was in a constant state of fear that I would get a call that my 31- year-old brother was dead. In October, he called me to tell me yes he was a heroin addict, but a new treatment center had opened near his home and he wanted to get clean. He asked if I would go with him, and I said of course yes. His insurance wouldn't cover a dime of this treatment. It would be all out of his pocket at $100 a day plus the cost of meds. For someone working at a $30,000 or less a year job, paying for housing, utilities, food, (he never did receive public assistance)-- He was too proud for that-- this cost was more than he could do. Again I told him I would be there and pay for whatever he couldn't. I convinced him he needed more of a support system than just me and he finally told our parents. We were we were raised in church and came from a large religious family. He was so ashamed of what he had become he didn't want the family to know and the majority of them still don't know to this day. I am hoping, as this letter was written anonymously, eventually he will share this with the family, maybe preventing other members from going down this road. He will tell them when he is ready. My mom and I went with him to his first appointment at the suboxyne clinic, and one of us has been at every appointment since. It is wonderful-- he has a session with a psychiatrist at every visit. It's more than prescribing meds. They are doing the counseling to make sure their patients get clean. I am proud to say that after only four months, not only is he clean but he has weaned off the suboxyne. He still goes for counseling and has the nurse's cell that he can call 24 hours a day if he's having a hard day. In the future he wants to tell his story and help others facing the same crisis. Madam President, I have been reading stories of people addicted all over the State of West Virginia. I have stories from your State also, Madam President. I would like to read that for you. This is in New Hampshire--Sandown, NH. This is Kathleen's story. I am sure she has sent you the same copy she sent me. She wants her name to be known. My name is Kathleen Stephens. I am a 56 year old RN, BSN, from Sandown, NH. I am currently the Director of Clinical Service at a nationwide hospice company. My story is much like thousands of others out there, pretty average, fairly normal. I have two children; a 33-year-old son who graduated with a degree in Mathematics from Boston University and a 31- year-old daughter who graduated with a psychology degree from Assumption College. I myself have a Bachelor of Science and Nursing degree and my children's father a Bachelor's degree in business from Wharton School of Business in PA. I give you this detailed background for to you see that we are a well educated and successful family. We are a white, mid to upper middle class who have always lived in a beautiful neighborhood surrounded by loving families whose children played outside, joined peewee soccer, little league, softball, basketball and girl scouts to name but a few. We were the home in the neighborhood where all the children loved to play. We took our children to drive in movies, camping, the beach, museums and always visited their grandparents. We were normal, that's all, or what we perceived was normal. When speaking with our children now, they both recount wonderful childhoods and deem themselves ``lucky.'' Our house was filled with love. I hugged my kids all the time, never hesitated to demonstrate to or tell them how much I loved them. They had grandparents who were always around, who also demonstrated love for them. About 5 years ago, my daughter, and her boyfriend, an Intern at Tufts Medical School decided, after being together for 2 years that they would move to Sacramento. I was devastated inside but encouraged my daughter to follow her heart. Over the subsequent years, our communications went from daily to weekly to scattered. Each conversation seemed more distant than the last. We saw her an average of twice a year; most significantly, when we paid her expenses to come home for Christmas. Her boyfriend never came; he distanced himself from us almost immediately. I'm sure at this point you know the story. About 18 months ago I finally confronted my daughter asking what was wrong, seeing her go from a loving daughter to a distant person I no longer knew. Over the previous few years, she turned into a virtual stranger. I told her I loved her no matter what and that I would be there for her. At that time she denied any issue. A few weeks later she was in the hospital and called me. Apparently, she had hit bottom. She confided that she was a heroin addict. I was more than shocked. She had been in a substance free dorm in college, hated drinking, drugs and was pretty straight laced overall. I kept myself in check saying that no matter what I would support her, asked her to come home so we could help her. She confided that it started with a prescription for opioids that her boyfriend had shared with her. He was given one for back pain years before, got hooked and decided she might just like it. So, amazingly she did come home, but she went back a few months later. She then returned to get clean again and went back a few months later. She overdosed multiple times, of which I knew nothing until recently. Her boyfriend gave her IV heroin while she was in the hospital being treated for pneumonia to keep her habit going. He was the one, I found out later, that he shot her up because she hated doing it. He had developed a hold on her that was a bond of heroin high. I knew the drug had gotten her when, due to the stress of everything happening, I ended up in the hospital ruling out a heart attack. She drove me there, dropped me off and went to get high (I found out later). I ended up being fine, stress of course, and she ended up going back home yet again. She stayed clean after going into a rehab, which kicked her out after 8 days because her insurance was declined. She then attended NA-- Narcotics Anonymous-- meetings almost daily and got a job that she loved. In the meantime, her boyfriend was found out through a ``random'' drug test and suspended. She was clean for 4 months, the happiest four months of my life. We spoke every few days, or texted. Her voice was truly hers again . . . her laughter, her expressions, her humor. I felt she was finally back with us. She had left her boyfriend and went into a sober living home. Life was good and I was so grateful to have my daughter, my best friend, back. About 3 months into her sobriety she decided to reach out and try to get her boyfriend sober as well, the beginning of the end. At exactly month 4 she went to his house and he had a ``surprise'' for her. She was new in her sobriety, just once she said, and she fell back down the rabbit hole. I knew when she didn't return my calls or texts that it was bad. But finally she responded; she was back into it again, but she'd get out she promised. The next 8 months were a few weeks clean then back into drugs again. I did not send her money. Honestly, she never asked. She knew I'd never support her habit. Around Thanksgiving 2015 she had had it. She called me and said she wanted to get back into rehab and leave her boyfriend permanently. Her life was no longer worth living. Weeks of trying to get her into rehab went unsuccessfully when we finally found Clean and Sober in Sacramento. At that point she was clean two weeks, had slowly packed up or sold her belongings and was ready for the break. But she had to sneak out to get away from her very controlling, manipulative partner; and she did. The happy part: She is today 60 days sober. She has a new job (She had been fired from the other one), which she loves. She blocked her boyfriend from her phone, her email and her facebook. She is the daughter, once again, that I know and love, but I love her regardless of the disease of addiction. Love the addict, hate the disease. And for right now I thank God, pray alot, and take it one day at a time. I have another one here I want to share with you. The thing I wanted to share, Madam President, is this: My State and your State have probably been hit as hard as any two States in the country. We have people coming to us all the time. We are fighting every way we can. We are introducing pieces of legislation. We are not worrying about who is Republican or Democrat. How can we help Americans--the beautiful people in New Hampshire, the wonderful people in West Virginia, who are facing more deaths, more disease, more destruction to the family? I want to share with you that when I first got elected--Senator Byrd had died in 2010. I was Governor of the State of West Virginia. I had to make a decision. I thought maybe I could come to Washington and help with the experiences I had and what I had seen in my State and times. We had challenges. After I was elected to the Senate, I had gone back to Oceana, WV. At that time it had been called ``Oxyana'' because drug use was so rampant in this beautiful town. I remembered this town because when I was a freshman in college, my roommate was from this town. It was the most beautiful town I had been in. They had everything. What a privilege it would have been to grow up in this beautiful town, but I could see many years later it was not the town I knew or remembered in my mind. I went to the middle school. These were all children in fifth to eighth grade. I tried to give pep talks. I wanted to get them involved and tell them how good they could be, how much we are counting on them, what they need to get a good education and contribute something back to society, and how fortunate and lucky they are to be in this little town. After I finished speaking--they were attentive and cooperative--there was a group of them. They asked: Can we talk to you privately? I will never forget this. These were 12- and 13-year-old boys and girls. There had to be six or seven of them. I went in the back room and sat at a table. They started talking and telling me their stories. These were stories they had watched and were telling me. This was the first time I had ever heard from a child up close and personal who said: My dad worked at the mines. He had a back problem. He got hurt. They kept giving him pills. We lost our house. Mom and dad were fighting. They got divorced. We lost everything. I've got nothing now. My grandparents were watching me while I was trying to take care of us. My dad is an addict. I heard these stories from these five kids. They were all pleading. Now fast forward to the year 2015. I go back to the same school. These kids that were 12 years old are now seniors in high school. The same group wants to talk to me. They had lived a clean life, but I think about what they have gone through and what they have seen. Then I sit down with another group of 12- and 13-year-olds from the same area. They are telling me stories about how they are watching their lives before them when they watch a boyfriend or a stepfather because the family had broken apart, the mother remarried or whatever, and the person that she is with is a drug addict. This little child watches her mother get shot up and killed because of the drugs the boyfriend shoots into the mother. Can you imagine a 12- or 13-year-old having to live with this and see this happen in their home? What we are asking is simply for the Food and Drug Administration to change, to be the watchdog to help us. They are supposed to protect us. They don't say: I did my job. The pharmaceutical company told me they made this drug, and this is the way it was made. This is what it was supposed to do. We checked it out. Everything is fine; leave it on the market. You are not looking at the welfare of the people. You know what it does. You know it is addictive. We have no treatment centers. We are doing nothing to treat this. We are not challenging these pharmaceutical companies who are good companies. They do a lot of good and put a lot of products out there that are very good, but they are bringing these opiates on the market quicker than ever before, more powerful than ever before, and they know what is going to happen. I am challenging all of them. I think the FDA should challenge them. We are not going to approve more opiates. We are not going to let you bring on the market stronger opiates that we know are addictive and will ruin people's lives. If they will do that and challenge these companies to come out with new research and development that can scientifically give us relief needed for people who have chronic pain without making them addicts who lose their lives--we should be able to do that in this great country. I am going to read you a story from Kentucky, my next door neighbor, the majority leader's home--Kentucky and West Virginia. This is Emily from Louisville, KY. My name is Emily Walden. I am a mother who lost my 21-year- old son to a drug overdose in 2012. My son TJ came from a good family, was a member of the Kentucky National Guard and the most respectful young man you could have ever met. TJ made an initial poor decision that led to an addiction to the drug Opana; he had unlimited access to this drug during that time. TJ did not want to die from this. He tried very hard to overcome his addiction and I tried very hard to save his life. I started researching the drug Opana about five years ago and would like to share with you what I have learned that illustrates the need for changes to our FDA policies and approval processes for all opioid drugs. The drug Opana contains the opioid Oxymorphone which was removed from the market in 1979 due to the overdose deaths and addiction this drug was causing across our country. In 2002, the FDA started holding IMMPACT meetings every year allowing pharmaceutical companies to pay money to be included in discussions and changes to clinical trials, design. We call that pay to play--the impact it has because they are able to go to these types of settings and get absolute front row seats with the people they are trying to persuade to take another look at these drugs that might have been taken off the market because they were deemed too dangerous. This is allowed to go on. It has been going on for far too long, and the FDA is part of it. This is part of the change that needs to be made and made immediately. Endo Pharmaceuticals, the manufacturer of Opana, attended each one of these ``pay-to-play'' meetings. In 2003, Endo Pharmaceuticals brought the drug Opana to the FDA for approval and was denied due to the overdoses that occurred during the clinical trials. In 2006, Endo Pharmaceuticals again brought the drug Opana to the FDA for approval but this time using new clinical trial that applied a modified process, called ``Enriched Enrollment,'' which removed patients with preexisting opiate sensitivities from the trial. The Enriched Enrollment process skews results and seriously underestimates risks associated with the proposed drug involved in the clinical trial. In addition, the FDA ignored their own review guidance by bypassing their advisory committee and approved Opana for moderate to severe pain. At the time Opana was approved, our country was already experiencing an explosion of overdose deaths and addiction from the overprescribing and misrepresentation of the safety of opiates. In addition to causing thousands of deaths and addiction, the approved use of Opana has now been directly implicated in an outbreak of Hepatitis C and HIV cases in the State of Indiana. The FDA has continued to use Enriched Enrollment-- Or pay to play-- to approve new opiates and override or bypass altogether their advisory committee for new opiate approvals and for new uses of opiates further contributing to the overdose deaths and addiction. These process changes must stop. The year after my son died I traveled to Washington DC for the first time in my life and was very fortunate to be able to meet with the then Senate Minority Leader-- Now Senate majority leader-- Senator McConnell, the next year I had nine meetings which included a meeting with then acting Director Botticelli of ONDCP, DEA Administrator Michelle Leonhart and seven meetings with Senator's staff. In 2015 I had thirteen meetings scheduled. I am not going away! We need change to curb this horrible epidemic that started with prescribed opiates and the mistakes that were made need to be corrected. How many people have to die? How many more people have to become addicted? The FDA is sending the wrong message to physicians by continuing to approve opioids during the worst drug epidemic our country has ever faced.

Mr. MANCHIN

Mr. MANCHIN. Continuing: Around the age of 15-16 Zack started self-medicating with nerve pills, smoking pot, and drinking. Zack did his first stint in rehab at the age of 16. He went to Florida to a rehab facility because they were able to arrange everything including his flight before we even got a call back from any facility in our state. Zack was in treatment 60 days and returned home. He was clean for several months and then started using again. Zack graduated to using pain pills. From there he started shooting up pain pills. A child who had a horrific fear of needles was now injecting opiates to escape his painful reality. Zack was robbing people and living house to house and on the streets. Then when he figured out heroin was a cheaper fix and more accessible, this became his new drug of choice. Zack was arrested and given the chance to go to rehab again. He completed another 2 trips to rehab, one being 60-90 days and another being around 30. He came home, relapsed and went to jail for 4 months due to failed drug tests. He spent 4 months in regional jail without receiving one counseling session or any help with substance abuse. When he was released from jail he was very lost and didn't know what to do with his life. He was clean several months before relapsing again. Zack is now in a peer recovery program in West Virginia. He is 20 years old and on his 4[th] stint in rehab. He is fighting for his life in this program along with about 120 other men. He has been to jail, and has lost close to 20 people in his life due to overdoses. Being a mother of an addict is a nightmare. From learning your child has this disease to fighting with insurance companies and doctors to get your child treatment. When Zack was a juvenile, I was told by treatment providers that insurance companies did not consider substance abuse in children a life threatening disorder. I had to run up in a house when he ran away and handcuff him and take him to a hospital high as a kite. I had CPS called on me for having my intoxicated son handcuffed because I wasn't a police officer. I had mental hygiene warrants lost. My son was released by a hospital at a moderate risk to suicide and because of that treatment centers wouldn't even consider admitting him into their program. I was told by hospital staff that if I had a medical card instead of private insurance or if my child was a ward of the state, they could get him more help. I contemplated quitting my job in order to get a medical card for my son. I have been asked by rehab to take out loans in order to get my son help. I have had to borrow thousands of dollars from my family in order to get my son into treatment. I have driven my child to hospitals while he is nodding in and out and I was crying so hard I couldn't see. I have stayed up for 24 hours in a row watching my son detox in hospitals. I have followed ambulances for miles transferring him [to] facilities. I have missed Christmases, Thanksgivings, and birthdays with my son. I have gone months and months without a good night's sleep. I would cringe every time the phone rang or there was a knock on the door. No mother should ever have to just wait on that phone call or for that [knock] on the door. I have also had to sit my other 2 children down and explain to them that I don't love them any less than I do their brother. I have had to tell them I have to dedicate more time to Zack because I know the 2 of them will be okay but I have to try and keep their brother alive. You see this epidemic is not only affecting the person who is the addict. It is destroying families and communities. Siblings are forgotten. Marriages and relationships are being destroyed. Entire families are getting PTSD. Crime is at an all-time high. The list goes on and on. The whole system is broken when it comes to treating mental illness and addiction. Until we get the money to fund treatment and more treatment centers, this epidemic will continue to get worse. If my child had cancer, or any other chronic disease, he would be able to get immediate treatment. He would be able to get good treatment. Addiction is a disease that may start with a poor choice, but is ultimately a disease. Until we are able to provide adequate treatment immediately to those suffering we will continue to lose a generation of people. I pray that no one else has to experience the pain my family and my son has experienced, but unfortunately, this disease has entered into every community, every neighborhood, and into most families. It's just a shame that we live in the greatest nation in the world and this is our reality. Mr. President, I thank my colleagues for allowing me that. I am very concerned about where our country is going and the role the FDA plays. We need a cultural change. I thank my colleagues.

Mr. MANCHIN. I should be done here in about 2 or 3 minutes. If I can just finish this letter--I have many more, but I will come back later.

Mr. MANCHIN. I didn't think there was a time barrier on this. I am so sorry. I ask unanimous consent to continue at least this letter.

Mr. MANCHIN. First of all, Mr. President, I want to say to my colleagues, Senator Markey of Massachusetts and Senator Blumenthal of Connecticut, this doesn't have a partisan home. This is not a Democratic or Republican issue. This is an epidemic that is devastating our entire country. It doesn't matter whether someone comes from affluence or is socioeconomically challenged. Rich or poor, it makes no difference. What side of the track you live on makes no difference. This is an epidemic that hits us all in its devastation. If Senators will just talk to their communities, their law enforcement officials, they will tell you that over 80 percent of all crimes are drug-related. Look at the cost, look at the economy, and look at the devasation in the cost of lives it is taking. Something has to be done. We are expected to vote to confirm the President's nominee for Commissioner of the FDA, Dr. Robert Califf. Let me say this about our President, President Barack Obama: I think he is taking this seriously. He has come to the State of West Virginia, and I am very appreciative of that. He has seen firsthand the devastation it has taken in all aspects of life in West Virginia. We are a State that is hit as hard as if not harder than other States. It is the No. 1 killer in my State. There are more people dying by legal prescription drug abuse than any other cause. So the President came there and he saw that. I am just asking the President to make that major commitment to our having a cultural change by giving us someone who will shake it up from the top. I believe Dr. Califf is a good man. I really do. I believe he is a qualified man. I met with him and spoke with him, and I directly asked him--I said: Dr. Califf, you come from a culture where basically the large pharmaceutical industry that supplies these types of products to the market and expects the FDA to approve them are the people who have supported you for the last 20 years. It is just human nature that that is hard to change and hard to say no to. So with that being said, I said that I think we need a cultural change. I think he understands that and respects my position. I respect his. I just think he is the wrong person at this time of need for the position. We need to shake it up. He is going to continue to serve as Deputy Commissioner of the FDA's Office of Medical Products and Tobacco, but the Commissioner of the agency must be someone willing to lead in a different direction. With 51 Americans dying every day due to an opioid overdose, the FDA now more than ever needs a Commissioner who is a champion committed to changing the way this agency handles opioids. As I have said many times before, my State of West Virginia has been hit hardest. Drug overdose deaths have soared by more than 700 percent since 1999. We lost 600 West Virginians to opioids last year alone. But that is not the only problem in West Virginia. Since 1999 we have lost almost 200,000 Americans to prescription opioid abuse. I am here today to urge all my colleagues, before they take their vote today, to think about the citizens of their States who are suffering from prescription drug abuse. Think about all those you know who have lost a loved one due to this epidemic. Each and every one of us here knows someone whose life has been wrecked by legal prescription drug addiction. This is a silent killer. There is not a person whom I know in any community or any group in any setting whom I can't look at and say: There is not one of you in this room who doesn't know someone in your immediate family or among your extended family or friends who hasn't been affected. That is how rampant this is, but it is something we don't speak about much. We are concerned. It could be our son, could be a brother or a sister, could be a mother, father, aunt, or uncle, but we don't want to talk about it. We are afraid it has been stereotyped. We need a culture change. As the agency overseeing the approval of these addictive drugs, the FDA plays a critical role in this epidemic, and as my dear friend from Massachusetts, Senator Markey, said, the FDA might have to change what it stands for. It really has fostered this drug addiction more than any other agency. Think about the fact that it is being produced legally, approved by the Federal Government in a legal way, and it is being prescribed in legal ways. We are the most addicted Nation on Earth. Over 80 percent of the opioids consumed in the world are consumed by 5 percent of the world's population, that 5 percent all living in this great country of ours. Something is wrong. Something is wrong, and everyone should be concerned about this. I tell our children and grandchildren, Mr. President, when I speak in schools--I say: You don't have to worry about another country ever taking us over militarily. We have the greatest military the world has ever known. We have the strongest economy, and we are the only ones who can correct the mistakes we have made in our economy because it is so strong. They do not think they have to take us on militarily or be worried about overtaking our economy; they are going to sit back and wait until we become so addicted we can't function. This is what we are dealing with, and this is why it is of such importance. The agency has been so callous about their approach to this epidemic. As a matter of fact, time and time again they have failed to consider the public's health. One would assume that if the Food and Drug Administration makes a decision that something is good and consumable, they would have looked at the effect it has on the public, the health and well-being of the citizens of this great Nation. Yet it has actively stood in the way of addressing this opioid abuse epidemic--and not only not considering it but prohibiting others from doing it. For years, the FDA delayed before finally agreeing to reschedule hydrocodone--to reschedule. Let me explain where I am coming from. When I first came to the Senate in late 2010, early 2011, I said: My goodness, we have Vicodin and Lortab, the most prescribed opioids on the market--more than any others. OxyContin had already been moved to a schedule II, and Vicodin and Lortab were schedule III. It took us 3 years to get the FDA to reschedule Vicodin and Lortab and all opioids to a schedule II. It took 3 years--and after their own advisory committee overwhelmingly recommended that it be rescheduled. That means a doctor can only give out a 30-day supply at one time without a doctor visit. Under a schedule III, they can give out 90 days and continue to just call it in without seeing a doctor. They were putting this stuff out like they were M&Ms. So that changed and we finally got that done, but it took forever to get it done and we never could understand why. Since that change went into effect, we have seen the number of prescriptions for hydrocodone products, such as Vicodin and Lortab, fall by 22 percent. We know it worked because they were overprescribing. So 22 percent--that is 26 million fewer prescriptions and 1.1 billion fewer pills on the market. That is how much just that one change--it took 3 years but should have been done in 3 weeks. It took 3 years because the FDA stalled their decisionmaking. Then, after finally making the important step after 3 years, the next day--the next day that that was done--the FDA approved the dangerous drug called Zohydro. The next day, after 3 years of waiting to get all opiates to a schedule II, they came out and recommended Zohydro and approved it, even when their own experts--their own advisory committee made up of experts--recommended 11 to 2 against bringing this most powerful, lethal drug on the market. This drug has ten times the hydrocodone of Vicodin and Lortab, with the capability of killing an individual with just two pills, and just recently the FDA approved OxyContin for use for children 11 years of age. Can you believe that? They did that without having any experts or any advisory committee's consent or recommendations. This decision means that Pharma is now legally allowed to advertise OxyContin to pediatricians under certain circumstances. We have seen the devastating impacts of this type of advertising, and we have years of evidence that shows that drug use at an early age makes a child more likely to abuse drugs later in life. These decisions illustrate the FDA's inability to consider public health and assess the realities of this deadly epidemic. While I recently accepted the agency's decision to finally start listening to the advice of its expert advisory committee--they have just decided now they are going to start listening to their advisory committees. No way have they decided to take their recommendations. They are just going to listen. While this might be a step in the right direction, finally, of their listening and basically taking the advice of experts but not acting on it, I think is absolutely meaningless. The change at the FDA needs to be fundamental, and it needs to come from the top. We need a leader who changes the current way of thinking. Unless a major cultural change is implemented at the FDA, similar instances will continue to occur into the future. Meanwhile, our Nation's opiate epidemic continues only to worsen, and our friends and families are further torn apart by the impact of addiction. If Dr. Califf is confirmed today, I do not feel confident that this culture change is going to take place. Dr. Califf has close financial ties with the pharmaceutical industry. Between 2010 and 2014, Dr. Califf received money through his university salary and consulting fees from 26 Pharma companies, including opiate manufacturers. In the past, Dr. Califf has actually described the FDA regulation as a barrier--not a safeguard for public health, but a barrier. I believe the FDA needs new leadership, new focus, and a new culture. Dr. Califf's past involvement with the pharmaceutical industry shows that he would not be the person to do that. He would not have the impact or leadership capabilities the Nation needs to stem the tide of the opioid crisis. I believe the FDA must break its cozy relationship with the pharmaceutical industry and, instead, start a relationship with the millions of Americans impacted by prescription drug abuse. It is because of this belief that I am urging my colleagues to vote against the confirmation of Dr. Califf. My office has been absolutely flooded with stories from West Virginians and Americans who want their voices heard. I am going to read just a couple of letters because I think it is important to know the impact of these letters. I absolutely want you to hear it. And I know every State has been impacted the way my State has. This is Susan's story: My name is Susan. I am from West Virginia and I am the mother of three children, ages 20, 16, and 14. My oldest son's name is Zack. Zack is an addict. Zack grew up in a small town with his mother, father, brother, and sister. He played sports throughout his childhood including football, baseball, wrestling, and basketball. He got good grades in school. He went to church with his grandparents and wanted to be a preacher until the age of 11 or 12. My husband and I divorced when Zack was 13, and it deeply affected Zack. We moved to a new town where Zack and his brother and sister started into a new school system. Around the age of 15-16 Zack started self-medicating with nerve pills----

Mr. MANCHIN. Mr. President, I thank my colleagues.