Tom Harkin

Mr. HARKIN

Mr. HARKIN. Mr. President, as Senator Alexander has indicated, we have been working together for a long time to develop legislation that will ensure that patients have access to the compounded drug products they need and that they can have greater confidence that their compounded drugs are safe. We ultimately landed on a package that preserves current law for traditional compounders but creates a new option for entities that choose to operate outside the bounds of traditional pharmacy practice to allow them to serve as safe sources of the compounded drugs that providers and their patients need. We have worked very hard to craft a proposal that preserves patient access to clinically necessary medications while helping to ensure that providers have access to safe sources of compounded drugs. As Senator Alexander noted, section 503A of the current Federal Food, Drug, and Cosmetic Act governs traditional compounding. This bill preserves current 503A but removes the unconstitutional advertising provisions so 503A is the uniform policy nationwide. Similarly, we do not change current law regarding repackaging or biologics. The Senate bill established a new regulatory regime for repackaging and biologics, but ultimately, after our bipartisan, bicameral discussions, we made no changes to current law on those subjects nor do we change current law on the compounding of animal drugs. The existing restrictions on animal drug compounding have not been rigorously enforced. We will be asking GAO to take a closer look at the laws regulating animal compounding because we weren't able to address it in this package. This bill also creates an entirely new source of quality compounded drugs. It permits entities that want to serve as outsourcers for entities that need large volumes of clinically necessary compounded drugs to provide those drugs, as long as they register with FDA and pay a registration fee, adhere to high quality standards, submit to FDA inspection, and tell the agency if adverse events occur. I recognize that many patients need drugs that are not available from pharmaceutical manufacturers, and I have no interest in cutting off patients' access to those drugs. But I do want to ensure that when patients do need a compounded drug, it is safe. By ensuring that current law--FDCA section 503A--applies nationwide and creating a new safe source of outsourced drugs, this bill should enhance patients' ability to get the drugs they need without having to worry about their safety. Practice of Medicine

Mr. HARKIN. Mr. President, today, with final passage of the Drug Quality and Security Act, we have helped to ensure the safety of compounded drug products and secure the pharmaceutical supply chain. We have clarified the law governing traditional compounding and created a new source of high-quality compounded products for hospitals and other providers who need large volumes of compounded drugs. We have also set in motion a revolution in the distribution of pharmaceuticals--within a decade we will know exactly how our drug products travel through the often-complicated distribution system so that we can identify counterfeit and adulterated drugs before they get into American medicine cabinets. By passing the Drug Quality and Security Act, we have taken an important step to improve American families' access to lifesaving drugs and medical devices. The bipartisan process that produced this bill has been quite remarkable. I have worked closely with my colleagues on both sides of the aisle and both sides of the Capitol, as well as industry stakeholders, patient groups, and consumer groups, to solicit ideas and improvements on the critical provisions in this bill. We have a better product thanks to everyone's input. I would like to extend a special thank you to my colleague, Ranking Member Alexander. I have been working with Senator Alexander on this since he became ranking member, and it has been a wonderful and cooperative partnership. I can honestly say that we would not have gotten this done without his excellent leadership and wise council. I thank the Senator. I also thank all of the HELP Committee members, as well as members off the committee and their staff, who were thoroughly engaged with this process from the beginning as part of the bipartisan working groups. Each of you has contributed significantly to this legislation, and I am sincerely grateful for your contributions. On that note, I specifically thank the staff of Ranking Member Alexander's office. I thank David Cleary, Mary-Sumpter Lapinski, and Grace Stuntz. I also thank Hannah Katch from Senator Franken's staff, Rohini Kosoglu from Senator Bennet's staff, Jennifer Boyer from Senator Roberts staff, and Anna Abram and Margaret Coulter from Senator Burr's staff. I know that they have developed close working relationships with my staff throughout this process, and I am sincerely grateful for your dedicated efforts. I also thank my own staff on the HELP Committee, who have spent many a night and weekend with Senator Alexander's staff, other member offices, and our colleagues in the House working to come to consensus on the critical policy issues in this legislation. I thank Pam Smith, Jenelle Krishnamoorthy, Elizabeth Jungman, Nathan Brown, Emily Schlichting, Allison Preiss, Kate Frischmann, Abraham White, Jim Whitmire, Chung Shek, Frank Zhang and Evan Griffis. We would be remiss if we did not also thank the Congressional Budget Office for their knowledgeable and capable team that dedicated many hours to estimating the budgetary effects of this legislation. Finally, we owe an enormous debt of gratitude to the staff members in the Legislative Counsel's Office--specifically Kim Tamber, Stacy Kern- Sheerer, and Bill Baird. They, too, worked long hours, nights, and weekends to assist my staff in drafting this legislation and working out technical issues. This bill's final passage is a victory for the millions of Americans who need safe medicines--a victory that would not have been possible without the dedicated work of our Senate family. I thank you all for your extraordinary public service. Welcoming Back Senator Inhofe

Mr. HARKIN

Mr. HARKIN. Mr. President, I wish to cover the bill we are on, the Drug Quality and Security Act. Before I do, I ask unanimous consent that at the end of my remarks the Senator from New Hampshire, Ms. Ayotte, be recognized to speak.

Mr. HARKIN. One year ago, we were at the beginning of our effort to understand one of the worst public health crises this country has experienced in recent years. We were just learning about the New England Compounding Center's astonishing disregard for basic procedures to ensure that the products they were manufacturing were sterile. We were shocked and saddened by the news that hundreds were sick and dozens had died from infections caused by NECC's blatant disregard for patient safety, and we were fearful for the fate of the thousands of additional patients who had received injections of NECC products. Despite the urgency of that crisis, the bill we are considering was not slapped together overnight--far from it. It is the product of a full year of careful bipartisan policy collaboration, and it rests upon the factual foundation developed through the bipartisan oversight investigation that Senator Alexander and I launched over 1 year ago. When we learned of the NECC tragedy, we did not rush to pick up a pen and dash off a quick legislative answer. Instead, we sought to understand what that story was, what its causes were, so we could develop legislation which would make a difference in the future and not just make headlines. In early October of 2012, shortly after the outbreak became known, this is what the outbreak looked like. We had these States with 64 deaths and 750 people got sick. I don't mean they just got sick overnight and then got better. Some of the people who lived will have lingering illnesses for the remainder of their lives. In many cases they will never be able to work again because of meningitis. My partner's home State of Tennessee was very hard hit with 153 cases. Michigan was the highest with 264 cases. But this is what it looked like when this outbreak occurred. As we can see, there were a couple out West, and it was starting to spread in that direction. Thankfully, the Centers for Disease Control and Prevention was able to intervene and find the source of it and stop it; again, another example of how CDC protects the American people. When this happened, we began to talk directly with various stakeholders to understand it. We continued to talk to the FDA and the CDC on their investigations. We held briefing calls with the Massachusetts Board of Pharmacy, where the NECC was located. We talked to an array of compounding pharmacies and purchasers of the compounded products. On October 25 of last year, to explore the need for and potential contours of legislation, the committee launched a bipartisan process to examine the respective State and Federal roles in regulating compounding pharmacies. My oversight team worked with Senator Alexander's to gather documents from FDA and from the State of Massachusetts that shed light upon how NECC had been allowed to grow so large with so little oversight. Last November, we released an initial report and held a hearing exploring the statutory and regulatory gaps that contributed to this tragedy. Our bipartisan investigation continued and culminated in a final report released on May 22 of this year. Over the course of this investigation, we explored how drug compounding has evolved as an industry over the past couple of decades. Drug compounding is a traditional and longstanding activity of pharmacies. It serves an important role in our health care system. Compounding is when just a few people--maybe only one person--needs a certain compound of a drug. So a pharmacist, maybe not with the classic mortar and pestle but with other devices, mixes, compounds the specific drug that is needed. Maybe it is needed for a few people in a hospital, a specific chronic illness that someone might have. This is sort of the traditional compounding, where you can't just get a prescription for it and go down to the pharmacy and have it filled, simply because there is not that big of a demand for it. But over the last couple of decades a number of large-scale drug compounding companies have started to produce large batches of high-risk drugs for national sale. For example, at the time of the meningitis outbreak, NECC's sister company called Ameridose was providing prepared IV mixtures to 25,000 hospitals and facilities across the country. Despite a scope of operations that makes these companies much more similar to drug manufacturers than to pharmacies, they primarily faced oversight similar to State-licensed community pharmacies rather than the more rigorous quality standards governing traditional drug manufacturers. Our investigation found that both NECC and Ameridose had lengthy track records of producing drugs of questionable sterility and potency, and both had been the subject of repeated adverse event reports and consumer complaints. The committee review of FDA documents indicates that between 2002 and 2012, NECC was the subject of at least 52 adverse event reports, exposing the dangers created by its hazardous compounding practices with documented issues including the failure to ensure the sterility of equipment and products, the distribution of drugs containing particulate matter, the manufacture of superpotent and subpotent drugs, mislabeling of drugs, inaccurate ``beyond use'' dating, and the illegal distribution of drugs in the absence of patient-specific prescriptions. Similarly, between 2007 and 2012, internal documents indicate that Ameridose was the subject of at least 18 adverse event reports. Ameridose was cited in 2008 for producing a compounded version of the pain reliever fentanyl that was more than 100 percent stronger than the standard level. What was happening at NECC during this time period was unfortunately an example of a larger problem across the industry. In an effort to understand better the risks posed by increasingly large drug compounding companies, the FDA undertook surveys of compounded drugs in 2001 and 2006. In each of those surveys, about one-third of the drugs sampled failed one or more standard quality tests. In the 2006 survey of sterile injectable drugs, 33 percent of the samples contained either not enough or too much of the active drug ingredient. Between 2001 and 2011, FDA documents indicate at least 25 deaths and 36 serious injuries, including hospitalizations, were linked to large- scale drug compounding companies, including 13 deaths in 2011 alone. Between 1998 and 2005, FDA documented at least 38 deaths and 210 injuries from drugs that were contaminated, mislabeled, or caused overdoses because they contained more of the active pharmaceutical ingredient than indicated. These include the deaths of 6 infants and children, and at least 18 other children paralyzed, burned, hospitalized, or suffering from other severe reactions, and these numbers likely understate the actual number of adverse events because current law, unlike what we have in this bill, does not require reporting of adverse events. Our bipartisan investigation concluded that large-scale drug compounders continue to pose a serious risk to public health. At the time of our final report in May, we had identified at least 48 compounding companies that had been found to be producing and selling drugs that were contaminated or created in unsafe conditions in just the preceding 8 months since this outbreak. I guess what I am saying is, if you follow this, this had been going on for some time but it kept getting worse and worse as more and more of these large-scale drug compounders found they could get away with it. In that same time 10 drug compounders had issued national recalls because of concerns about contamination, and 11 drug compounders had been ordered by State licensing agencies to stop producing some or all drugs. Our investigation concluded that in order to reduce the serious and ongoing risk to the public health from compounded drug products, it is essential that a clear statutory framework be enacted that requires entities compounding drugs outside of traditional pharmacy practice to engage in good manufacturing practices and to better ensure the sterility and quality of their drugs. So we developed this bill, the DQSA, as we called it, to address the regulatory gaps that we identified in this investigation. Under the legislation before us, large compounders such as NECC or any other compounder that chooses to operate outside of traditional pharmacy practice have only one legal option: They must register with the FDA. They must follow good manufacturing practices. They must tell FDA when their products hurt people; otherwise, they must follow the manufacturer-like requirements that apply to outsourcing facilities under this bill. If they are not traditional compounders and they do not meet the requirements for outsourcing facilities, our bill says FDA can shut them down immediately. The Drug Quality and Security Act is a carefully crafted bill that not only responds to the NECC outbreak but to the root causes that I have gone over that go back almost 2 decades, that really led up to this tragedy. It is good bipartisan policy. I pointed out the other day in my remarks, and I point out again today, it has wide industry and consumer support: the Academy of Nutrition and Dietetics, the American Pharmacists Association, the Chamber of Commerce of the United States, large drug manufacturers, and also consumer groups--the Center for Science and Democracy, the Center for Medical Consumers, and others. So it has both consumer and industry support. I wanted to take this time to lay out the background as to why this bill is so vitally important. I will also point out the House of Representatives passed this bill on a voice vote. Now we have it here at the desk. It is the same basic bill we passed out of our committee on a bipartisan unanimous vote. Last night we had a 97-to-1 vote on cloture to proceed to this bill. That ought to be an indication that this is an important bill, but one that has broad bipartisan support. Now, under the rules of the Senate we have 30 hours, of which I am now taking my part of 1 hour. I don't intend to take the whole hour. Then we go 30 hours, and then we get on the bill. If one person then--this one person--continues to object, I guess we will have to file cloture on the bill. That will take 2 days to ripen, 2 days for cloture to ripen. Then we will have yet another vote on cloture on the bill. I assume we will get 97 to 1. Then we have 30 hours after that, and then we vote. I think that takes us to Sunday, if I am not mistaken, if we stay here. This is not really part of what I want to talk about, but I think this is an important reason why I have supported a change in the rules of the Senate since 1995. We cannot continue to be a 21st century country, to be a major world power, and operate under 19th century rules and regulations. It is just not right that one person, one Senator, any Senator--I am not pointing fingers at anyone. I am saying anybody, any one Senator in the face of a bill that is not only vital for the health and safety of the American people but which has broad bipartisan support--that one person could tie up the Senate for literally a week or more through procedural roadblocks. That is why I say we need to do something about the rules around this place. If this were a contentious issue, I could see the need to slow things down. This has to do with the health and safety of the American people. A lot of time and effort went into this bill, by Republicans and Democrats, FDA, CDC, pharmaceutical companies, consumer groups. That is why I think it has such broad support. I hope we do not have to go through all this. But if we do, we do. There is no doubt in anybody's mind that this bill will pass and it will probably pass on a 97-1 vote. But why tie up the Senate for all this time? Why put off the signing of a bill that would get action to protect the health and safety of the American people? I hope we can bring this to a resolution and have a vote up or down on it. Frankly, I think we could probably voice-vote the bill. I think we could ask for unanimous consent--but for one person--and then we could voice vote it. Then, if there is an objection, maybe we do have to have a rollcall. If someone wants a rollcall, that is their right, but at least let's vote on the bill and get it out of here. That is the least we can do to protect the health and safety of the American people. I yield the floor.

Mr. HARKIN. Mr. President, I object.

Mr. HARKIN. Mr. President, on behalf of leadership, I object.

Mr. HARKIN. Mr. President, I want to say a couple things about my objections. I know a lot of Senators, when they object, always use that phrase: reserving the right to object. But I think if you look at the Senate rules, there is no such provision for reserving a right to object. I have always made it my habit that if you object, you object, and then, when you get time on the floor, you explain why you objected. Thus, I am taking my time now to explain why I objected. The Senator from Louisiana propounded two unanimous consent requests. The first was basically that we go ahead and get to the bill, the compounding bill that we are on right now; that his amendment, which has nothing to do with the bill, by the way--and I think he would agree with that. It has nothing to do with it. It is not even relevant, not even germane to this bill. It has something to do with ObamaCare and whether we tell people whether our staffs are going on the exchange. So it has nothing to do with this bill. It seems odd that the Senator from Louisiana says he wants an inalienable right to be able to offer an amendment to this bill, but no one can offer an amendment to his amendment. It is kind of a double standard, to my way of thinking. He says that we vote on his amendment and that no second-degree amendments be in order. Why not? If amendments were allowed to be in order on the bill that were nongermane and nonrelevant, why shouldn't there be a second-degree amendment allowed on his amendment? Kind of a double standard. He wants it all his way, without thinking about the rest of the Senate. Well, again, that is why I keep saying we need the rules changed so that not one person can demand such outrageous accommodations. Again, this bill is so important to get passed and to get to the President so we can begin this process of protecting the health and safety of the American people. We know how to treat compounders, and they have to register and stop doing what they have been doing in the past. This is vitally important. The Senator says: Well, we can expedite it if only you will do it my way. Why should we have to do it his way? When 97 people already voted on this bill, when it passed the House by unanimous consent, why should it be: Well, this one Senator has the right to stop this bill, slow it down, unless we meet the demands of that Senator? Yes, it is outrageous in terms of how we conduct our business in the Senate. Again, I have argued for a long time that rules need to be changed. I have also argued for a long time that the minority ought to have the right, the inalienable right, to offer amendments, but amendments that are relevant and germane to the bill before you; otherwise, you get amendments on everything from Timbuktu to wherever on any bill, and that you can keep offering them and offering them and offering them. It was my understanding that the majority leader offered to the Senator from Louisiana an up-or-down vote on his amendment--not on this bill, but at some point an up-or-down vote, as long as that was the definitive vote on the amendment and it would not keep coming up. It is further my understanding that the Senator disagreed with that, that he wanted the right to bring it up again and again and again and again. I think this is, again, an outrageous imposition of one Senator's views and considerations on the entire Senate. I would say to the Senator that there ought to be some way for the Senator to get an up-or-down vote on his amendment--not on this bill. It is not relevant. It is not germane. I do not think it is relevant or germane on the Defense bill. I will say more about that in a second. But we have a lot of things coming down the pike before we leave here this year--or even in the next session of this Congress--to accommodate the Senator from Louisiana on his amendment. But why should we have to keep voting on it time after time after time if we have one dispositive vote on it up or down, which is, as I understand, what the majority leader offered? Secondly, in regard to the second unanimous consent request proffered by the Senator from Louisiana, to which I objected on behalf of the majority leader--I am not the chairman of the Defense Authorization Committee, nor do I have the right to bring legislation to the floor-- again, the Senator wants everything accommodated to his wishes because if you read the unanimous consent request, the Senator asks the Senate then proceed--well, there is a word missing there--it means: to the consideration of S. 1197, the Defense authorization bill. That is the right of the majority leader. It is the majority leader's right to bring legislation on the floor--not my right, not the right of the Senator from Louisiana, not the right of a Senator from anyplace else. I do not know if the majority leader wants to go to the Defense authorization bill next. I do not know, but that is not my decision to make. But the Senator from Louisiana says he wants to make that decision, and to make sure the Senate does just that. I would say to the Senator from Louisiana, well, when he becomes the majority leader, he would have that right. So he wants, again, to be able to bring up his amendment--again, which has nothing basically to do with the Defense authorization bill--and, again, that no second-degree amendment be in order on his amendment--again, a little bit of a double standard. He wants the right to offer a nongermane, nonrelevant amendment to a bill, but nobody can offer any amendments to his amendment in the second degree. Well, I think we see this for what it is. The Senator obviously wants to vote on his amendment, maybe today, maybe tomorrow, maybe next week, maybe next month; I do not know how many times he wants to vote on his amendment. He was offered the right for an up-or- down dispositive vote on that amendment. My understanding is--it is only my understanding; I do not know whether this is correct--that was turned down by the Senator from Louisiana. So I say that is why I objected to both of these requests, because on the compounding bill, of the necessity to get it through. I do not know whether the Senator's amendment would fail or lose. I do not. But I do know that the House has said they will not take the compounding bill back. You might say the House is unreasonable. I do not run the House. I do not run the House. All I know is the House passed it by unanimous consent, sent it over here, and said if it is amended, they will not then revisit it. That is what the House said. So if the Senator's amendment, as worthy as it might be to some, is put on the compounding bill, that is the end of the compounding bill. That is the end of protecting the people of America, their health and their safety, that we have worked so hard to come together. That is why it has no place on this bill. It may have a place, and I say that the Senator should have a right for a vote on his amendment at some point on either a relevant bill or a freestanding bill, that the Senator gets the right for an up-or-down vote on his amendment, either as a freestanding bill itself or as a relevant or germane amendment to some other bill on the floor. He should have that right but not to stymie, to stop a bill that is so vital to the health and safety of the American people. That is why I objected.

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that Teresa Danso- Danquah, Emily Flores, and Charles Hayes of my staff be granted floor privileges for the duration of today's session.

Mr. HARKIN

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

Mr. HARKIN. Madam President, I have high hopes that the Senate will soon vote to enact the Drug Quality and Security Act, the so-called compounding and trace and track bill. This legislation helps ensure the safety of compounded drug products. It also secures the pharmaceutical supply chain. I am pleased to report that it is the product of excellent bipartisan collaboration on the HELP Committee, where I worked very closely with our ranking member, my good friend Senator Lamar Alexander. It also reflects productive conversations with our colleagues in the House, including Chairman Upton and ranking member Waxman of the House Energy and Commerce Committee. The House passed this bill on September 28. Now it is our turn to do our part. Title I of the bill addresses drug compounding. This is basically what happened here just over a year ago, when we were shocked to learn one of the worst public health crises that we have experienced in recent years was a meningitis outbreak that claimed the lives of 64 Americans and sickened 651 people in 20 States. You can see the hardest hit were the home State of Senator Alexander, 153; Indiana, 93; Michigan, 264; Virginia 54, New Jersey, 51; Florida 25. Twenty States. A lot of people got really sick. I will be talking in a moment about those that still linger today. What this outbreak did is it brought attention to the legal and regulatory gaps that allowed owners and managers at the New England Compounding Center to disregard basic procedures to ensure that the products they were manufacturing were sterile and safe. This gross negligence had heart-breaking consequences for families nationwide, patients that were sick--patients such as Karina Baxter, whose three adult children--Anita, Andrew, and Brian--lost their mother, and whose community lost a dedicated math teacher and tutor when she died of this meningitis outbreak at age 56. Dawn Elliot, from Indiana, who used to scuba dive in her free time is now in unrelenting pain and has had to give up her job and deplete her savings. Evelyn Bates, from Michigan, who was diagnosed last November, continues to struggle with tremendous pain every day, and her daughter had to quit her job to take care of her. Dennis Blatt lives on the West Virginia-Ohio border with his wife and three young children. They have had to watch their father go from being an involved parent with a steady income to a man whose daily life feels, in his own words, like a ``slow, tortuous death.'' These meningitis outbreaks linger on. It also has a personal sensitivity to me. My older brother some years ago went deaf at a very young age because of meningitis. So it has lingering effects for a lifetime. That is what happened a little over a year ago. Although we know that it was not just an isolated incident, we know it was the biggest. This chart is somewhat hard to read. It shows--going clear back to 2001--that we have had 4, 11, 64, 18. In other words, every year we have had some results we have noted from compounding that made people sick or cause deaths. So this has been ongoing for a long time. It is just that what happened a little over a year ago in Tennessee and in these other States was that the dam broke. It is beyond all comprehension how many people got sick and died. So again, in response to these facts, beginning last year Senator Alexander and I convened the members of the HELP Committee, with assistance from Senator Franken and Senator Roberts, in an effort to identify the gaps in current policy, to solicit stakeholder views, to craft bipartisan legislation to better ensure the quality of compounded drug products. We formally solicited three rounds of public comment. We held two public hearings before marking up the bill last May. Then over the summer we worked with our colleagues in the House to craft a package with strong bipartisan and bicameral support. Now, the compounding provisions in this bill are an unqualified step forward from current law and practice. Basically, what this bill does in the compounding in title I--I will get to title II in a second--it distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. So those who wish to remain in traditional compounding, that we might know where they are making small amounts for a certain type of illness or for a certain hospital--that sort of thing--they stay under the State boards of pharmacy as they are in current law. An entity that neither stays within those limits of traditional pharmacy compounding nor registers as an outsourcing facility, if they do not do one of those two, then they are illegally selling unapproved drugs. So that is what it does. It distinguishes. It defines the Food and Drug Administration's role in the oversight of these outsourcing facilities. They will be subject to FDA oversight in much the same way as traditional drug manufacturers are today. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have authority and resources to conduct risk-based inspections. In other words, the lines of responsibility are more clearly defined. I give much credit to my friend from Tennessee for continuing to work on who is raising the flag, who has the flag, and who is responsible, because we found out there was a confusing mess for everybody about who was responsible and who was not. Thanks to Senator Alexander, we have cleared that up in this bill. The bill offers providers and patients better information about compounded drugs, and it directs FDA to make a list of FDA-regulated outsourcer facilities that will be available on their Web site. It requires detailed labeling of compounded drugs and prohibits false and misleading advertising. Finally, it clarifies current Federal law regarding pharmacy compounding. It strikes the unconstitutional provisions that were in current law which led to a lot of this mess. We had different courts in different parts of the country interpreting it differently. So anyway, we resolve that patchwork and apply a uniform standard nationwide. Now, that is title I. Title II of the bill is the track and trace provisions. Basically, this committee, again working in a bipartisan fashion a little over a year ago--as you may remember--brought an FDA user bill to the floor, passed and signed by the President. That cleared up the upstream part of where drugs come from; in other words, from the initial--from the plant derivation to the distilling of a product to everything--all the way up to the manufacturing. So now we have a much better regulation, a clearer picture of drugs that come from China and Indonesia and the U.S.--no matter where they come from, up to the manufacturing standpoint. What we did not have at that time was a real understanding of or an agreement on how to control it from the manufacturer down to the consumer. So our committee got involved. Again, Senator Alexander was helping to lead the way with Senator Bennet and Senator Burr--almost 2 years working on this issue. So now we have this system. I think this chart shows it. As I said, everything up to the manufacturer we took care of in the FDA user bill. Now this bill takes care of everything from the manufacturer down to the dispenser; that is, down to the consumer. So no matter where the drug goes, whether it goes directly from a manufacturer to a wholesaler to a dispenser, or whether it goes from here to a secondary wholesaler, another secondary wholesaler, and another secondary wholesaler, we found that in this country there is a patchwork, all kinds of different ways for a drug to get from a manufacturer down to a consumer. So Senator Burr, Senator Bennet, Senator Alexander, and our staffs worked together to get this picture put together and to have a track and trace so that we can track the drug. No matter how it goes, we can track it and we can trace it. That will come into being over 10 years with electronic interoperable product tracing. You might say that 10 years is a long time. I would point out that the House had 27 years. They agreed with us and made it 10 years. But that is for electronic interoperability. Beginning in January 2015, they will have to start paper tracing. So there will be paperwork, but it will take 10 years to get it all at a unit-level and all electronic and interoperable. You can understand, it takes a long time; different manufacturers and different suppliers have different systems. So these will be worked in over that period of time. But we will have tracing after January, 2015. It establishes nationwide drug serial numbers and requires a pathway to unit-level tracing, as I said. It strengthens licensure requirements for wholesale distributors and third-party logistic providers. Again, there was a lot of hodgepodge of different kinds of licensures for wholesalers. We strengthened that. Then, as I said, we have a nationwide serial number established for that. That will come 4 years after the date of enactment. That will serialize drugs in a consistent way across the country. Again, this is a bill that many might say is long overdue. Better late than never. I am sorry it took a terrible calamity such as the outbreak of meningitis to get us to really focus on this and move it. But it did. I think this is a good example of where the Congress can work in a bipartisan, bicameral fashion. I met Chairman Upton on the House side earlier this year to talk about a pathway of getting this done. In fact, what we are working on here is the House bill. The House passed it by unanimous consent. If you have been reading much about the House, you know they do not do a lot by unanimous consent. That just shows you how much work went into the bill and how it was done in a true bipartisan, bicameral fashion. So the House passed it by unanimous consent. Now we have it. I daresay, but for a Senator, one person, we probably would have passed it by unanimous consent here. I have not found anyone who is opposed to this bill and who does not recognize that this is well supported. We have a plethora of people and industry and consumer support: American Pharmacists Association, American Public Health Association, Biotechnology Industry Organization, plus a lot of the big pharmaceutical manufacturers and some of the small pharmaceutical manufacturers. Everyone recognizes that we need a better system to clearly outline who the traditional compounders are and who the outsourcers are, to give the FDA clear-cut authority over one segment, give the States the clear-cut authority over the other segment. As I said, if you do not fall into one of those two, you are outside the law. So it really does clear it up. This will ensure the quality and safety of the drugs on which patients rely. We have a cloture vote later today. I am hopeful we will have a good strong vote on cloture on this bill. As I said, I honestly can say standing here I have not heard one Senator from either side of the aisle tell me or inform my staff that they were opposed to the bill as such. I hope we have a strong vote. I am going to yield the floor and again pay my compliments and my highest respect to Senator Alexander for his leadership. His State was hit very hard. I know he is very sensitive to that. I know from my talks with him that it pained him a great deal to see so much suffering and death in his own State. Senator Alexander got on top of this and pulled us all together and basically said: We have to get it done. So I thank Senator Alexander very much.

Mr. HARKIN. Mr. President, I suggest the absence of a quorum.

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that Nathan Brown, a detailee on my staff, be granted floor privileges for the duration of the consideration of H.R. 3204, the Drug Quality and Security Act.

Mr. HARKIN. Mr. President, I ask unanimous consent that Tatiana Lowell-Campbell and Benjamin Friedman of my staff be granted floor privileges for the duration of today's session.

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that I be permitted to speak for up to 5 minutes in opposition to the Toomey amendment and that the Senator from Wisconsin also have 2 minutes to speak in opposition.

Mr. HARKIN. Mr. President, over the course of this debate, we have documented the tremendous business community support for this bill, including over 100 major companies. A key reason for that support is that ENDA is closely modeled on title VII of the civil rights law. Employers are familiar with the law, they understand how to comply with the law, and it provides certainty. The many Fortune 500 companies that have employment nondiscrimination policies in place have modeled their policies on the nondiscrimination requirements of title VII. Unfortunately, by proposing an entirely new definition of businesses that would qualify for an exemption from the Employment Non-Discrimination Act, this amendment calls into question that very certainty. ENDA already exempts the same religious organizations that qualify for an exemption under title VII of the Civil Rights Act. Under current law, the exemption includes not only houses of worship--churches, synagogues, and mosques--but also religious schools and religiously affiliated hospitals. The exemption in this bill passed the House of Representatives on a broad bipartisan basis, 402 to 25, in 2007. In determining what organizations should qualify for religious exemption, most courts have also said that where the primary activity of the organization is commerce or profit, despite strongly held religious beliefs by the owners, the organization may not discriminate in hiring. That is what this amendment, I believe, seeks to change. This amendment would allow entities that are ``officially affiliated'' with a religious society to discriminate on the basis of sexual orientation and gender identity. This is a new term that is undefined in the text of the amendment and could lead to thousands of for-profit businesses being allowed to discriminate. Some examples that have been suggested could qualify for the exemption could be a private employer whose only ``affiliation'' with a religious society is receiving a regular newsletter from that society or a private employer who sponsors a fundraiser for a religiously affiliated nonprofit or a private employer who provides goods and services to a religious organization. Again, this amendment would open the floodgates for all kinds of lawsuits. Courts would be inundated trying to figure out what does ``officially affiliated'' mean because there is no definition to that. The definitions we had before provide that kind of certainty to our business owners. Our Nation's civil rights laws require those who participate in commercial activity must adhere to the broad principles of fairness and equal treatment. In potentially allowing secular commercial businesses to discriminate in hiring and other employment practices on the basis of sexual orientation or gender identity, this amendment threatens to gut the fundamental premise of ENDA that all workers should be treated equally and fairly. So while I urge my colleagues to oppose this amendment, I wish to note that the sponsor of the amendment supported beginning debate of the bill. His amendment is one that goes directly to the substance of the bill that we are debating and not an unrelated issue. So I wish to compliment the author, Senator Toomey. This is the way we should operate in the Senate. As many know, I have been advocating for rules changes since 1995. One thing I have always adhered to is that it is the right of the minority to be able to offer relevant germane amendments to a bill. The author of this amendment has adhered to that. This is certainly relevant. This is certainly germane. That is why I compliment him for providing us with a way the Senate should work. But the amendment, I believe, is ill-defined. It would open the floodgates for all kinds of new cases. It would disrupt businesses all over America. So for that reason I urge my colleagues to oppose the amendment by the Senator from Pennsylvania. I yield the floor.

Mr. HARKIN. Mr. President, today the Senate is sending a clear message that all Americans are entitled to earn a living free from discrimination and to be judged in the workplace based on qualifications, ability, and integrity. The Employment Non-Discrimination Act is simple and clear. It states that private businesses, public employers, and labor unions cannot make employment decisions--hiring, firing, promotion, or compensation-- because of a person's actual or perceived sexual orientation or gender identity. The bill is modeled on title VII of the Civil Rights Act, a law that has been in place for almost 50 years. It is a law that is well understood by employers and is strongly supported by employers. More than 50 years ago, with the Civil Rights Act, we took the first steps to eliminate discrimination at work. Since that time we have ensured that the employers may not discriminate on the basis of race, sex, national origin, religion, or age. In 1990 with passage of the Americans with Disabilities Act we ensured that Americans were not discriminated against on the basis of a disability. Today, for the first time, the Senate goes on record prohibiting discrimination at work on the basis of sexual orientation and gender identity. Yesterday I entered into a colloquy with Senator Leahy, the distinguished chairman of the Judiciary Committee with regard to Senate amendment No. 2012. I would like to further clarify my response to Senator Leahy. As Senator Leahy clearly set forth in his question to me, this amendment simply says that you cannot retaliate against an organization solely because it qualifies for the exemption under section 6(a) of ENDA. The amendment is not intended to undermine in any way current or future Federal, State, or local civil rights protections--States and localities can still enforce their own nondiscrimination laws for violations within their jurisdiction, regardless of whether an entity is exempt under the national ENDA legislation. We have had a very collaborative process on this bill, and I would like to take this opportunity to thank all of those who have made that possible first, to the sponsors of the bill, Senator Merkley, Senator Kirk, Senator Baldwin, and Senator Collins, all of whom have put in many hours behind the scenes working to build support for this bill and make passage today a reality. Thank-yous also go to their staff: Jeremiah Bauman, Cade Clurman, Amber Shipley, John Kane, Katie Brown, and Betsy McDonnell. On my HELP Committee staff I would like to thank Beth Stein, Lauren McFerran, Chris Williamson, and Pam Smith. I would also like to thank the HELP Committee minority staff who also worked to get this bill through a very collaborative process: Kyle Fortson, Kai Hirabayashi, and David Cleary. A special thank-you goes to Dan Goldberg, who recently left my HELP Committee staff but did a tremendous job on this bill up through the committee markup. I commend all of the staff for helping to make final passage of this bill a reality. I thank the Chair.

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Armed Services be authorized to meet during the session of the Senate on November 7, 2013, at 9:30 a.m.

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Banking, Housing, and Urban Affairs be authorized to meet during the session of the Senate on November 7, 2013, at 10 a.m., to conduct a hearing entitled ``Housing Finance Reform: Essential Elements To Provide Affordable Options for Housing.''

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Energy and Natural Resources be authorized to meet during the session of the Senate on November 7, 2013, at 9:30 a.m., in room 366 of the Dirksen Senate Office Building.

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Foreign Relations be authorized to meet during the session of the Senate on November 7, 2013, at 11 a.m.

Mr. HARKIN. Mr. President, I ask unanimous consent that the Subcommittee on Consumer Protection, Product Safety, and Insurance of the Committee on Commerce, Science, and Transportation be authorized to meet during the session of the Senate on November 7, 2013, at 10 a.m. in room 253 of the Russell Senate Office Building. The Committee will hold a hearing entitled, ``Demand Letters and Consumer Protection: Examining Deceptive Practices by Patent Assertion Entities.''

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on the Judiciary, Subcommittee on Oversight, Federal Rights, and Agency Action, be authorized to meet during the session of the Senate, on November 7, 2013, at 1:30 p.m., in room SD-226 of the Dirksen Senate Office Building, to conduct a hearing entitled ``Justice Denied: Rules Delayed on Auto Safety and Mental Health.''

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that Zachary Kachevas and Nicole DuBois, of my staff, be granted the privilege of the floor during the remainder of today's session.