Frank Pallone

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the gentlewoman from Massachusetts (Ms. Clark).

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 5102, the Substance Use Disorder Workforce Loan Repayment Act. This bill would create a loan repayment program to provide loan repayment assistance to substance use disorder providers in exchange for providing substance use disorder treatment and recovery support services in areas with high need for such services. Mr. Speaker, I urge my colleagues to support this legislation. I thank the main sponsor, Representative Clark, for her leadership and Representative Sarbanes. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I also urge my colleagues to support the bill, and I yield back the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the gentlewoman from Michigan (Mrs. Dingell).

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 5041, legislation offered by Representative Walberg, Representative Dingell, and Representative Hudson, that will allow hospice workers to safely dispose of controlled substances, thereby reducing the number of unused controlled substances that are at risk of diversion or misuse. Mr. Speaker, I rise in support of H.R. 5041, legislation offered by Representatives Walberg, Dingell, and Hudson that will allow hospice workers to safely dispose of controlled substances, thereby reducing the number of unused controlled substances that are at risk of diversion or misuse. The diversion of unused prescription opioids is one of the major contributors to the opioid crisis facing our country. It has been estimated that around 70 percent of those who abuse opioids receive them from a friend or family, making it critical that strategies be put in place that will limit the ability for leftover controlled substances to fall into the wrong hands. Current regulations prevent hospice personnel from handling or destroying controlled substances following a patient's passing unless a state or locality allows them to do so under law. As a result, hospice workers have no choice but to leave behind controlled substances that may be at risk for abuse or misuse by those who were never intended to have access to such medications. H.R. 5041 would clarify that hospice workers would have the authority to handle controlled substances for purposes of disposal following a patient's passing. H.R. 5041 also makes clear that hospice workers tasked with disposing of unneeded controlled substances receive training through a qualified hospice program on how to properly dispose of these substances to ensure they cannot be extracted for purposes of further abuse. In addition, the legislation would also require hospice personnel to keep records on the disposal of the controlled substance, including what controlled substances were destroyed, as well as the time and manner in which the disposal occurred. I want to thank the sponsors of H.R. 5041, Representatives Walberg, Dingell, and Hudson for their work on this legislation, as well as the National Association for Home Care & Hospice and the National Hospice and Palliative Care Organization for their support and thoughtful input. Mr. Speaker, I urge Members to support this commonsense legislation, and I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, the opioid crisis has left no one untouched by its destruction. Every age, sex, race, and socioeconomic class has felt the weight of the opioid epidemic and the disastrous effects it has on the lives of those in our Nation. As this epidemic continues to grow, we have seen a dramatic increase in the number of children who are suffering opioid overdoses. A study published in Pediatrics earlier this year found that the number of children admitted to hospitals from opioid overdoses has nearly doubled since 2004. Another study found that kids between 12 and 17 accounted for 60 percent of the opioid overdoses in the pediatric population. In 2016, nearly 4,000 children and young adults between the ages of 5 and 24 years old died from overdose due to opioids, and that is why I support H.R. 449. This bipartisan legislation would require the Surgeon General to report on the public health impacts of synthetic drug use and abuse by adolescents between the ages of 12 and 18. Surgeon General reports have produced some of the most preeminent public health data available on some of the Nation's most pressing public health crises, from the adverse health consequences of tobacco use to reports on nutrition, HIV/AIDS, and violence. This is an important bill because it will allow the Surgeon General to address the impact of synthetic drug use on the youth population, and highlight the need for increased prevention efforts in the future. This bill, like so many of the bills we are considering today, helps raise awareness of the opioid crisis, and helps us to continue to chart a path forward in addressing this epidemic. But, Mr. Speaker, I am concerned that collectively these 57-plus bills we will consider in total, do not go far enough in providing the resources necessary for an epidemic of this magnitude. With 115 Americans dying every day, we must ensure that people have access to treatment. The bills the House will debate this week do not do enough to expand treatment for millions suffering from this crisis. Additionally, Mr. Speaker, I would be remiss if I did not also acknowledge that the Republicans' ongoing efforts to repeal the Affordable Care Act gut Medicaid and take away critical protections for people with preexisting conditions, and would have a devastating impact on people who suffer from opioid substance abuse. When discussing the opioid crisis on the floor this week, I urge my colleagues to remember that protecting and expanding access to care is the most critical piece of the puzzle. And any efforts to roll back the Affordable Care Act, such as another Republican-led attempt to repeal the Affordable Care Act and gut Medicaid, will hurt those who need it most. With that said, I am pleased to support H.R. 449 and the other bills we will consider under suspension of the rules today. Mr. Speaker, I yield as much time as he may consume to the gentleman from New York (Mr. Jeffries), the sponsor of H.R. 449.

Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I would also urge my colleagues to support this legislation, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I rise today to congratulate Rabbi Bennett F. Miller on his retirement as Senior Rabbi of Anshe Emeth Memorial Temple in New Brunswick, New Jersey. Rabbi Miller has dedicated over 40 years to Anshe Emeth and his commitment and leadership are truly deserving of this body's recognition. Ordained a Rabbi in 1974, Rabbi Miller joined Anshe Emeth Memorial Temple the same year. Since that time, he has provided outstanding spiritual guidance to the congregation and has promoted and supported a mission of social action and community service. In addition to his work at Anshe Emeth Memorial Temple, Rabbi Miller is also a member of the Jewish Agency for Israel Board of Governors and is Immediate Past-Chair of the Association of Reform Zionists of America. Prior to his service at Anshe Emeth Memorial Temple, Rabbi Miller served as the spiritual leader of Congregation Havurah in New York and the New Jersey State Advisory Council on the Holocaust. Rabbi Miller earned his doctorate from Princeton Theological Seminary and his Master of Arts and Hebrew Letters from the Hebrew Union College--Jewish Institute of Religion in Cincinnati, as well as a certificate in Non- Profit Management and Fundraising from New York University. Mr. Speaker, please join me in congratulating Rabbi Miller on his retirement and thanking him for his many years of dedicated service and leadership to Anshe Emeth Memorial Temple and the greater community.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, it is my distinct honor to rise today to congratulate Rev. Dr. Kenneth Saunders, Sr. and his wife, First Lady Shirley Harris Saunders, as they celebrate their retirement. Dr. Saunders and Sister Shirley have dedicated nearly 30 years of service to North Stelton A.M.E. Church in Piscataway, New Jersey, and their leadership and commitment are truly deserving of this body's recognition. Dr. Saunders and Sister Shirley are devoted to their faith and community. Dr. Saunders is Treasurer of the New Jersey Annual Conference and First Episcopal District, a member of the Episcopal Committee for the African Methodist Episcopal Church and an officer on the Middlesex County Black Caucus. A dedicated public servant and an active member of the community for years, he also previously served on the New Jersey State Parole Board, the New Brunswick Theological Seminary Board of Trustees and as Chaplain for the Piscataway Police Department and Council. A community leader in her own right, Sister Shirley has also endeavored to improve the lives of others. Through her work with the New Jersey Conference Women's Missionary Society, the Nubian Sisters for Christ Ministry, the Shirley A. Saunders Youth Liturgical Dance Ministry, the North Stelton Scholarship Ministry, and many others, Sister Shirley has been a staunch advocate for youth and family issues . Her involvement with the New Brunswick Theological Seminary Ladies Auxiliary and the New Jersey Conference Women's Missionary Society, as well as other faith-based organizations, exemplifies her commitment to serving the Lord and community. Mr. Speaker, I sincerely hope that my colleagues will join me in congratulating Rev. Dr. Kenneth Saunders and his wife, Sister Shirley Harris Saunders on their retirement and thanking them for their years of service and leadership to the North Stelton A.M.E. Church and the greater Piscataway community.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I rise today to celebrate the 75th anniversary of Naval Weapons Station Earle. Since its opening, Naval Weapons Station Earle has been a pivotal base for the United States Department of Defense and its significance is truly deserving of this body's recognition on this historic milestone. Named after Rear Admiral Ralph Earle, the Chief of the Bureau of Ordnance during WWI, Naval Weapons Station Earle was called Naval Ammunition Depot Earle until 1974. It is based in two facilities in Monmouth County, New Jersey--the Waterfront, located in the Leonardo section of Middletown, and Mainside bordering Colts Neck, Howell, Tinton Falls and Wall Township. The two sections are connected by the military corridor and rail line, Normandy Road. The Waterfront includes a miles long finger pier--the longest in the Western Hemisphere--into Sandy Hook Bay. The pier sustained damage in Superstorm Sandy and now includes oyster reefs as an additional protection measure from future storms. Naval Weapons Station Earle was established out of the need for a munitions loading base in the Port of New York, a need that became increasingly pressing during World War II. The Leonardo and Colts Neck locations were chosen for their distance from densely populated and developed neighborhoods yet their proximity to important landmarks such as New York City, New York Harbor and the Atlantic Ocean. During WWII, the base served a vital role in transporting ordnance, including most of the munitions used in the invasion of Normandy. Naval Weapons Station Earle's strategic location has remained critical to our military, loading ships used in Operation Desert Storm and Operation Iraqi Freedom. Naval Weapons Station Earle encompasses nearly 12,000 acres and remains an active base today with over 1,500 personnel. With six times more loading capacity of any base on the East Coast, the support Naval Weapons Station Earle provides to our country is invaluable. Mr. Speaker, I sincerely hope that my colleagues will join me in recognizing the vital contributions of Naval Weapons Station Earle as it celebrates 75 years of operation.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I rise today to congratulate Aberdeen Township Hose & Chemical Co. No. 1 in Aberdeen, New Jersey on its 100th anniversary. The fire company continues to provide exemplary service to the residents of Aberdeen and is truly deserving of this body's recognition. Officially named the Aberdeen Township Hose & Chemical Co. No. 1 in 1977 after the change of the township's name, the fire company was organized in 1918 as the Oak Shades Fire Company, which is still used by many as the unofficial name to this day. Prior to Oak Shades Fire Company's founding, the section of Matawan Township that is now Aberdeen had no official fire company, leaving the protection of its residents to an understanding with the Matawan Borough Fire Department. Disagreements over the arrangement spurred citizens to organize its own fire company. The company included 27 charter members, four of whom served as the charter officers. In 1920, its name was changed, and in 1932, the Matawan Township Hose & Chemical Company No. 1 was official incorporated with the State of New Jersey. Throughout its 100 year history, Aberdeen Township Hose & Chemical Co. No. 1 has been supported by its members and the community. The fire company continued to expand and add equipment, ensuring the safety of its residents. Today, the fire company is housed in the Lloyd Road Firehouse, which was built in 1962 and includes five truck bays, a training room, a kitchen and a meeting room. Mr. Speaker, please join me in recognizing the 100th anniversary of Aberdeen Township Hose & Chemical Co. No. 1 and thanking its members for upholding the duty to serve and protect the community. This milestone and the dedication of the members of Aberdeen Township Hose & Chemical Co. No. 1 are to be celebrated.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I rise today to congratulate Rabbi Laurence Malinger on his 25 years of rabbinical service. Rabbi Malinger is a respected leader of Temple Shalom in Aberdeen, New Jersey as well as the greater community. His contributions are truly deserving of this body's recognition. Rabbi Malinger has served as senior rabbi of Temple Shalom since 1999 and continues to support the Temple's mission of religious education and guidance, social action and community service. He is a trusted confidant to his congregation and an inspiring spiritual leader. Prior to his service at Temple Shalom, Rabbi Malinger was Associate Rabbi of Congregation Beth Emeth in Delaware after serving the Congregation for four years as Assistant Rabbi and Director of Education. He has earned a Bachelor of Science Degree in Applied Mathematics, a Master of Education with School Psychology, a Master of Arts in Hebrew Letters and most recently was awarded an Honorary Doctor of Divinity for his dedicated years of service. A devoted man of faith and community involvement, Rabbi Malinger is engaged with various organizations and issues, including the Central Conference of American Rabbis, the Bayshore Ministerium, the Jewish Federation of Monmouth County's Jewish Addiction Resource and Garden State Equality, among others. Mr. Speaker, I sincerely hope my colleagues will join me in congratulating Rabbi Malinger on his 25 years of rabbinical service and thanking him for his many years of outstanding leadership to Temple Shalom and the community.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I want my colleagues on the other side to understand why so many of us over here have been so upset by this proposal today. As I think I said before, the House bill was bad enough. The Senate bill is worse for at least two reasons. One is our concern, on the one hand, that rather than these drugs or treatments without FDA approval would be handed to just terminally ill patients, that the Senate bill says that it would apply to people who have life-threatening situations. And the FDA and the commissioner of the FDA have stated quite clearly that they are concerned about the expansion from terminal to life- threatening, because it could be that people who have diseases like diabetes, severe diabetes, or chronic heart disease, for example, could make the argument that their situation is life-threatening, and, therefore, they can go and get these experimental drugs without FDA approval. So that is a huge loophole that is very disconcerting. The second thing is that the prohibition, if you will, on promotional activity with these investigational drugs is taken out by the Senate bill. So the worst thing of all, we talk about snake oil and advertising, is now is some unscrupulous doctor or manufacturer now going to promote this and say: Well, if you take this, this may save your life? So that is why the Senate bill is worse. But I want to go back to the whole idea. The problem that I have with all this is that once you take out the FDA, and the FDA is not involved anymore, the way this bill is set up, how do I know, if I am the patient and I hear from some doctor or through some promotion or whatever, that there is something that might help me, and I am desperate, how do I know that the doctor that I go to or the manufacturer who is promoting this drug, that this is actually not a bad actor, not somebody who is taking advantage of the situation because there is no FDA approval? In other words, who is going to determine whether this person's life is threatened or whether they are terminally ill? There is no FDA. Who determines that? Who is going to determine whether this drug has any effectiveness at all? Well, some of my Republican colleagues say: Well, it has to go through phase one, but phase one clinical trials could have 20 or 30 people. They are sometimes very small. The FDA doesn't really have any ability to control those clinical trials. Sure, they have some oversight over clinical trials, but there are clinical trials that take place all over the country with very few people, and sometimes the drug manufacturers who are experimenting with these trials, with these small groups, are not necessarily known manufacturers or large ones that we know will be safeguarding these drugs or treatments. So I just think the problem is, when we talk about snake oil and bad actors, it is almost as if the Republicans assume there are no bad actors. Because if you assume that there are, which I do, and there are bad actors who are going to promote something that is not going to be effective or is going to harm somebody, and that there is a manufacturer who is not someone we know, who is going to determine whether or not they are a bad actor or what they are doing? You need to have some kind of enforcement. You need to have somebody who is supervising this. Otherwise, it is any man for himself decides: I will try this drug. It went through phase one. Maybe it is not toxic. So I really worry that this debate on the other side of the aisle is not taking into consideration that there always are going to be people who want to take advantage of the situation and sell something that they are going to make a buck on that is not necessarily going to have any real oversight in this situation. So that is my fear. That is my fundamental fear about this bill, that these situations are going to arise, nobody is going to be in charge, nobody is going to know what is going on, and then the person is going to either die earlier or have some awful impact, and then they are going to say: Oh, how come the FDA didn't approve it? Or maybe they are going to assume the FDA approved it, and there is no FDA. They are gone. Mr. Speaker, in any case, I would urge my colleagues to oppose what I consider very harmful legislation, and I yield back the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from Florida (Ms. Castor), the vice ranking member of the Energy and Commerce Committee.

Mr. PALLONE. Mr. Speaker, I demand a recorded vote.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, again, I would like to respond to the previous Republican speaker. He made three comments that disturb me. One, he said that people should be able to try things, try the drugs or the treatment, when the benefits outweigh the risks. But how are they going to know that when the FDA isn't involved? When the FDA goes through various phases of clinical trial, not only phase one, which determines whether something is toxic, but beyond, to determine whether it is effective or whether it has harmful effects, then you do know. The FDA basically will tell you: Yes, the benefits outweigh the risk, and that is why we have an approval process in general for drugs, and that is why we have the expanded access, so that the FDA can look at it and say: Okay. Maybe you are going to risk this, but we want to make sure that you have some protection. The gentleman said that the FDA process is complicated or time consuming. First of all, there is an emergency process where you can simply get on the phone or the doctor gets on the phone, and within 24 hours you can be approved. But on the other hand, if it is not an emergency, the average approval time is 4 days. So I don't know how he can say that this is time consuming. And then the last thing he said is that there is consent, that the doctors and the manufacturers have to agree. But who is going to enforce this? Right now, because the FDA has to go through the expanded access process, the FDA has the enforcement. They can say: We are going to grant this; we are not; we are going to provide some safety or other protections. But if the doctor and some fly-by-night manufacturer decide that they want to give you this drug or treatment, who is going to enforce that? How do we know that the doctor is legitimate? How do we know that the manufacturer is not selling snake oil? Once the FDA is out of the picture, there is no way for the patient to know whether the doctor is unscrupulous, whether the manufacturer is unscrupulous. There is no review. There is no enforcement whatsoever. So, again, this is the problem once you take the FDA out. I understand there are some that don't like the FDA, don't think maybe they should be involved. But in the absence of the FDA, I don't know how you possibly could know whether this thing is going to help you, whether the benefits outweigh the risk, whether there is a bad actor involved, either with the doctor or the manufacturer. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I just want to respond briefly to the previous speaker on the Republican side. I don't understand how the gentleman can say that the expanded access program will continue even under right to try. The problem is, sure, on paper it will continue, but there wouldn't be any reason for anyone to go to the FDA. If the FDA is now out of the picture and all you have to do is find somebody who manufactures a drug or treatment and get the doctor to say, ``Okay, I will administer it,'' then you don't need to go to the expanded access program. You see, the problem is that the gentleman assumes that people will go to the FDA and they will know that the expanded access program exists. I think the very nature of this legislation, which basically says that you don't have to go to the FDA, is going to mean that people won't even know that that is an option. And if they can get somebody to give them the drug without going to the FDA, they will just do it. Let me just say this. I know the gentleman referred to the FDA's bureaucrats. I guess you could say that the people at the FDA are bureaucrats, but the FDA existed because, for many years before then, in the 19th century and early 20th century, all kinds of snake oil and things were advertised and promoted in the papers and in magazines, saying that this is going to cure that, this is going to cure that, and people demanded that there be some kind of Federal oversight as to whether drugs or treatments actually are effective, whether they have harm, whether they are toxic. That is why the FDA was started. So I guess I just don't understand, because the bottom line is there is very little evidence that there is any significant number of people who are denied treatment or drugs because of the expanded access program. At least then they know that some agency has looked at this to see whether it is harmful, whether it has some negative impact. The great concern that those of us on the other side of this issue have is that without the FDA, there is no guarantee that what somebody gets as a form of treatment is actually going to be meaningful, not be harmful. So I don't want to prolong my response to the gentleman, but I do think that you have to understand that those of us on this side of the aisle actually think that the FDA has a purpose and actually performs an important function, and I don't think we should deny that. I think it is unfortunate that there are those who think that somehow the FDA is not doing its job. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from New York (Mr. Tonko).

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in strong opposition to S. 204, the Federal Right to Try Act. This is dangerous legislation that threatens FDA's authority over ensuring that medical treatments are safe and effective. This bill needlessly exposes vulnerable patients to the risks of unproven medications. We heard last night in the Rules Committee from my Republican colleagues that we must accept and pass this legislation because the Senate is unable to pass a bill that passed the House earlier this year. That House bill was bad enough, but this Senate bill is much worse. I cannot fathom why my Republican colleagues are surrendering to the Senate and agreeing to pass a more dangerous version of the right- to-try legislation. The Senate bill, like the House bill, establishes an alternative pathway for experimental treatments that eliminates any review from the Food and Drug Administration and scientific and medical experts of an independent review board. This will provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients. At a hearing before our committee, FDA Commissioner Scott Gottlieb cautioned that S. 204 risked ``exposing people to unwanted side effects from experimental therapies.'' Now, supporters of this bill would have you believe that this legislation is targeted at those with terminal illnesses, but this is simply not the case. S. 204 would, in fact, apply to a much broader range of patients diagnosed with life-threatening diseases or conditions. And the term ``life-threatening disease or condition'' could include chronic and often manageable diseases, such as diabetes or chronic heart failure. If all patients with diabetes and other chronic but manageable illnesses were eligible, it would greatly expand the scope of the legislation well beyond the scope of most State laws and FDA's expanded access program. This exposes an even greater number of patients to risk and undermines our clinical trial program by diverting patients from trials that could support full approval to the alternate pathway. Commissioner Gottlieb also cautioned Congress that this legislation risked ``undermining a regulatory process that has been carefully crafted over many years to strike a very careful balance.'' The Commissioner noted that S. 204 would not subject all participants to the alternate pathway to critical regulatory requirements, such as labeling products as investigational, charging limitations, and restrictions on promotion and commercialization of such treatments. S. 204 could also impede the FDA from taking action against manufacturers and others that violate other provisions of the Federal Food, Drug, and Cosmetic Act. Under this bill, if a bad actor is not in compliance with good manufacturing practices or does not protect against intentional alteration--adulteration, I should say--or allows dishonest or misleading labeling, the FDA will not be able to take any enforcement action. But, more importantly, Mr. Speaker, this Federal right-to-try bill simply is not necessary, in my opinion. FDA has an expanded access program and has an approval rate of nearly 100 percent. To be clear, FDA's high approval rate is not just a rubberstamp for these applications. Of the applications FDA receives and approves, it also adjusts applications for 11 percent of patients to improve patient safety protections. This could include modifying the dosing, strengthening informed consent, or improving safety monitoring. We must protect patients from bad actors or from dangerous treatments that might make their lives worse. Without this critical review, there will not be any oversight to ensure that patients are not being taken advantage of or put in harm's way. The main reason this bill is being pushed is to chip away at FDA's authority to ensure the safety and effectiveness of our drugs. FDA oversight of access to experimental treatment exists for a reason: it protects patients from potentially snake oil salesmen or from experimental treatments that might do more harm than good. By removing the FDA oversight, you are counting on physicians and manufacturers to serve as the gatekeeper and protector of our patients. I simply don't buy that that is going to work. Supporters of this bill want to blindly believe that there are no bad actors out there, but imagine someone like Martin Shkreli promising a dying patient a cure that could save their life. Under this bill, FDA would play no role in determining whether or not Martin Shkreli could provide that drug to that dying patient. If S. 204 is signed into law, patients will be taken advantage of and will be harmed. Bad actors exist, and this Republican bill gives them the opportunity to prey on desperate people who are, understandably, looking for any treatment that may help save their lives. Now, let me also point out that the supporters of this bill claim to be helping desperate patients who are looking for hope. If this is such a patient-centered bill, why does every major patient organization overwhelmingly oppose it? Where is the call from patients for this legislation? More than 100 patient organizations, including the National Organization for Rare Disorders, Friends of Cancer Research, and American Cancer Society Cancer Action Network, sent a letter to Congress just yesterday opposing this legislation. In the letter, they stated: ``The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded FDA access process.'' Four former FDA Commissioners from both parties also oppose this Republican legislation, noting: ``There is no evidence that either bill''--that is the House or the Senate--``would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients.'' Mr. Speaker, S. 204, I know, is a key agenda item for the President and the Vice President; but I think it is dangerous for our patients, and it is an unprecedented attempt to roll back FDA's oversight of investigational treatments. Mr. Speaker, I urge my colleagues to stand with more than 100 organizations that have come forward to oppose this misguided and, I believe, harmful legislation. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I just want to urge support for this legislation. The support is obviously bipartisan, and I urge all my colleagues to support it. Mr. Speaker, I yield back the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from Virginia (Mr. Connolly).

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from Florida (Ms. Castor), the vice ranking member of the House Committee on Energy and Commerce.

Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from North Carolina (Mr. Butterfield), the lead Democratic sponsor, who is always out front on so many important healthcare issues.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of S. 292, the Childhood Cancer Survivorship, Treatment, Access, and Research Act. I want to particularly thank our lead Democratic sponsor, Mr. Butterfield of North Carolina, for promoting this bill. Nearly 16,000 children are diagnosed with cancer in the U.S. each year. Those children are forced to bravely battle a disease and carry burdens that no one their age should. The Childhood Cancer STAR Act gives those children and their families hope by encouraging improved research as well as survivorship programs for children with cancer. This legislation urges the National Institutes of Health to find new opportunities to expand research into pediatric cancer and survivorship, such as supporting the collection of biospecimens, as well as supporting research on the causes of health disparities in pediatric cancer survivorship. The bill also allows the Centers for Disease Control and Prevention to award funding to help States strengthen their infrastructure to track the epidemiology of pediatric cancer. This improves childhood cancer surveillance and helps to guide public health decisionmaking as well as research inquiry. Finally, this bill recognizes that expanding research that leads to treatments and cures is only part of the equation in improving the experience of children diagnosed with this disease. We must ensure that quality care is available to meet their needs for the remainder of their lives. Unfortunately, the battle with pediatric cancer extends beyond beating the disease. As many as two-thirds of pediatric cancer survivors suffer from long-term effects of their disease and treatment, including secondary cancers and organ damage. That is why this bill allows the Secretary of Health and Human Services to establish a pilot program to develop, study, or evaluate model systems for monitoring and caring for childhood cancer survivors through their lifespan, as well as to develop best practices for long- term followup services for pediatric cancer survivors. I will continue to support efforts like this to improve outcomes for cancer patients and survivors. However, unlike with this legislation, such efforts should proceed through the regular order process. Mr. Speaker, I urge my colleagues to support this bill, and I reserve the balance of my time.