Frank Pallone

Mr. PALLONE

Mr. PALLONE. Madam Chair, I claim time in opposition to the amendment.

Mr. PALLONE. Will the gentleman yield?

Mr. PALLONE. Mr. Chairman, I just want to urge support for this amendment. We need to make sure that emerging scientists from all populations understand Congress' commitment to ensuring that the funding is there to support our biomedical workforce. Requiring the Secretary to do outreach to colleges and universities that educate large numbers of students from underrepresented groups will ensure that all groups know of our commitment to making sure that funding is not a barrier to a career in biomedical research. I urge my colleagues to vote ``yes'' on the Sheila Jackson Lee amendment.

Mr. PALLONE. Mr. Chairman, I rise in opposition, although I do want to speak in favor of the amendment.

Mr. PALLONE. Madam Chairwoman, this amendment would require the NIH to report on their specific efforts to attract more women and racial and ethnic minorities into the biomedical workforce. It is clear that we must reverse the harmful trend of limited participation by women and racial and ethnic minorities in the biomedical workforce. To remain the world's leader in research, we must encourage the best and brightest from all populations to pursue biomedical research careers. Without robust participation by women and ethnic minorities, we risk losing our position as having the best biomedical workforce in the world. So I urge my colleagues to vote ``yes'' on this amendment.

Mr. PALLONE. Mr. Chairman, I just want to join with my other colleagues, Mr. Green and also the chairman, that we do understand the purpose of the Polis amendment, but we do have problems with it at the same time. We would like to have a conversation with Mr. Polis about it. I understand he is going to withdraw it. Then we would follow up and have a conversation and perhaps a meeting with the FDA as well.

Mr. PALLONE

Mr. PALLONE. I yield 5 minutes to the gentlewoman from Colorado (Ms. DeGette), the Democratic sponsor of the bill who has worked so hard to bring us to this day with this bill on the floor.

Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from Iowa (Mr. Loebsack).

Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentlewoman from California (Mrs. Capps), who is also a healthcare professional.

Mr. PALLONE. Mr. Chairman, I yield the gentleman such time as he may consume.

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

Mr. PALLONE. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, today the House is considering H.R. 6, the 21st Century Cures Act, legislation that will further encourage biomedical innovation and the development of new treatments and cures that will benefit millions. More importantly, this legislation will ensure that our country remains on the forefront of medical innovation while maintaining the gold standard for approvals of medical products. Mr. Chairman, this legislation is the product of numerous forums that occurred in Washington and around the Nation that heard directly from patients and advocacy groups about what innovations could make a difference in curing diseases. It is a truly bipartisan initiative of the Energy and Commerce Committee, and I want to thank Chairman Upton; Health Subcommittee chairman Mr. Pitts; Ranking Member Green; and our sponsor on the Democratic side, Representative Diana DeGette, for working together on this bill. The legislation includes a number of policy proposals that are meant to advance the work that NIH and FDA are already doing to encourage innovation in medicine, and I want to highlight some of those. First, it promotes and supports the best biomedical workforce in the world while also increasing the diversity of that workforce by requiring the NIH to ensure participation of scientists from underrepresented communities. Second, it encourages the development of precision medicine and next generation treatments. Third, it provides FDA with additional tools to make the drug approval process more efficient, such as streamlined data review and the use of biomarkers in clinical experience to ensure that new treatments can reach patients in a timely manner. Fourth, it modernizes clinical trials and supports the inclusion of diverse populations in clinical research through the National Institute on Minority Health and Health Disparities. Fifth, it facilitates the development of important antimicrobials and treatment for rare diseases and clarifies the regulatory pathway for software for medical applications at FDA. Finally--although not finally--there are many, many more positive developments in this bill, but I do want to mention last, ensuring interoperability of our health system which will lead to better access to health information, coordinated care, and improved outcomes. Most importantly, Mr. Chairman, 21st Century Cures also provides mandatory funding to both NIH and FDA to carry out the activities in this legislation, funding that is critically needed if Congress wants NIH and FDA to fund innovative ways to cure diseases. However, I am concerned that the very goal this legislation set out to achieve to encourage biomedical innovation and the development of new treatments and cures is undermined somewhat by a reduction in funding for NIH from $10 billion to $8.75 billion. This funding level, the larger one, the $10 billion over 5 years in the original bill, enjoyed the unanimous support from the members of the Energy and Commerce Committee and the 230 Members of the House who were cosponsors of H.R. 6. If Congress is truly committed to advancing and encouraging biomedical innovation, we must ensure that the Federal Government agencies we entrust with facilitating that goal have the resources to do so, and I hope that, at some point, as we move further, we can go back to the $10 billion. I would also urge my colleagues to reject any attempts to make the critical funding included in the legislation for NIH and FDA discretionary. The NIH ensures the innovation fund was created to be a resource to both NIH, FDA, universities, and researchers, including those just beginning their careers. Any efforts to make this funding discretionary threatens the commitment made in 21st Century Cures to encourage innovation. I also want to express, Mr. Chairman, my disappointment over the inclusion of controversial policy riders on what was otherwise a strong bipartisan bill. This inclusion, added to the bill after unanimous passage out of the Energy and Commerce Committee, is a political distraction from the discussion we should be having on the underlying policy. I hope that, tomorrow, my colleagues will join me in supporting Congresswoman Lee's amendment which will strike those troubling riders from the legislation. Despite these concerns, I remain totally supportive of the 21st Century Cures Act, as I believe it does take significant steps towards enhancing how we discover and develop innovative new medical treatments in the United States. Once again, I take great pride in the fact that we were able to do this on a bipartisan basis in our committee and report the bill out unanimously. Mr. Chairman, I would urge a ``yes'' vote, and I reserve the balance of my time.

Mr. PALLONE. Mr. Chairman, I yield 3 minutes to the gentleman from Texas (Mr. Gene Green), who is the ranking member of our Health Subcommittee.

Mr. PALLONE. Mr. Chairman, I would ask my chairman to proceed with another Republican because the gentleman seems to have more people.

Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from Illinois (Mr. Rush), who is the ranking member of our Energy Subcommittee.

Mr. PALLONE. Mr. Chairman, I yield myself the balance of my time to close. Before conclusion of debate, Mr. Chairman, let me just take a minute to recognize Chairman Upton and Representative DeGette for their steadfast dedication to this bill. This bill would not have been possible without their work for so many years, beginning when they had these forums where they heard from patients and the advocacy groups around the country. The process that they used to actually obtain information that became the basis for this bill was really unusual and was very, I would say, populist and grassroots in a way that I think I would like to see emulated in the future because it was so successful. It is further proof, I think, also that when we want to work together to achieve great things, we are capable. I know it hasn't always been easy, and the staff has had to work around the clock and on weekends and during holidays since January, but this is a good bill that I am proud to support. I just want to thank not only the members, but also the staff of Chairman Upton and Chairman Pitts. That is Gary Andres, Clay Alspach, John Stone, Carly McWilliams, Paul Eddatel, Robert Horne, Joan Hillebrands, Katie Novaria, Adrianna Simonelli, and Heidi Stirrup. Let me also thank Representative DeGette for her work, her staff as well: Lisa Cohen, Rachel Stauffer, and Elizabeth Farrar; Mr. Green's staff: Kristen O'Neill; and, of course, my staff: Jeff Carroll, Tiffany Guarascio, Kim Trzeciak, Eric Flamm, Rachel Pryor, Waverly Gordon, and Arielle Woronoff. Let me just say this: Obviously, I urge support for this legislation. I hope that we get a huge vote, but I think the biggest satisfaction that I am going to get when this passes and we work to get it passed in the Senate and to the President's desk is that every Member of Congress knows that, when we go home, there are always events with various advocacy groups. I think, of course, of the pancreatic cancer group because my mom died of pancreatic cancer about 5 years ago, 7 months after she was diagnosed, which is actually a long time. Many people die within 6 weeks or 2 months after diagnosis because the diagnosis takes so long and occurs too late, effectively. You go to these various events that the groups have. Sometimes, it is a run; or it is a walk. Diana DeGette mentioned ALS. I went to an ALS walk, I think, about 3 or 4 weeks ago. The typical response--and I am thinking of this last ALS walk--is that someone will come up to you and say: Why aren't you doing enough to find a cure? Why aren't you spending more money? Why aren't you prioritizing this disease? Why is it so difficult to have a clinical trial or to get involved in a clinical trial? For 20 years, most of the time, when somebody has brought that up, I haven't really had an easy response because, for many of the diseases, there hasn't been really much progress at all. Now, the biggest satisfaction I am going to have--and I have already had it over the last few weeks--is when I go back and I go to one of these events and one of the patients or advocate representatives says to me: Well, what are you doing about this? I will be able to say: Well, we have a bill called 21st Century Cures, and it does a lot of things that could make a difference in terms of what your concerns are. That, to me, is the greatest satisfaction, really, of our being able to pass this bill tomorrow. I would urge support on a bipartisan basis. I yield back the balance of my time.

Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Aguilar).

Mr. PALLONE. Mr. Chairman, how much time remains on each side?

Mr. PALLONE

Mr. PALLONE. Mr. Chairman, I yield 2\1/2\ minutes to the gentleman from New York (Mr. Tonko).

Mr. PALLONE. I yield the gentleman an additional 1 minute.

Mr. PALLONE. Mr. Chairman, I yield 2\1/2\ minutes to the gentleman from Oregon (Mr. Blumenauer).

Mr. PALLONE. Mr. Chairman, I have an amendment at the desk.

Mr. PALLONE. Mr. Chairman, I yield 2\1/2\ minutes to the gentleman from California (Mr. Lowenthal).

Mr. PALLONE. I yield the gentleman an additional 30 seconds.

Mr. PALLONE. Mr. Chairman, I yield 5 minutes to the gentleman from Illinois (Mr. Rush), the ranking member of our subcommittee.