Greg Walden

Mr. WALDEN

Mr. WALDEN. Mr. Chairman, I appreciate my colleague's amendment on this. I understand it. And I think it is important because it does strike at the heart of the issue and the concerns many of us on this side of the aisle have. The California Life Sciences Association told us that, if enacted, H.R. 3's Medicare part D foreign reference pricing proposal would reduce by 88 percent the number of drugs brought to market by small and emerging companies in California alone due to changed investor behavior. So they think up to 88 percent of the great innovations and cures they are working on will never come to market. They also think it would eliminate 80,000 biotech R&D jobs nationwide and reduce revenues by $71 billion a year. So, these are the people, predominantly out in California, that do this every day, that are living in this world of trying to create innovation and new lifesaving drugs. And they are saying up to 88 percent of the new drugs they are working on would never come to market. These are the small startups. We have heard a lot from others on the floor in the last 24 hours about Big Pharma. Well, we are not talking about Big Pharma here. We are talking about small, little startups, American entrepreneurs. If you think about Silicon Valley in the high-tech world, this is the equivalent in the biotech world. These are individuals who have an idea and a big brain, and they are coming together to come up with a cure to these diseases like SMA, Alzheimer's, sickle cell anemia, and things like that that we all struggle with in our communities. Our fear on this side of the aisle, as Republicans, is we know, based on the facts and the independent analysis of our Congressional Budget Office, based on the Council of Economic Advisers, based on the input of the very people who are in the trenches every day in these laboratories across America, where two-thirds of the world's innovation comes from in this space, that H.R. 3 will significantly reduce new cures coming to market. Now, we are all for lowering drug prices. I think we would have a unanimous vote on the provisions in our alternative here if we had a fair opportunity to take these one at a time. We are glad we have the opportunity to have the vote. I think, because there are 138 Democrats on the measures that are in what I would call our bipartisan proposal here, that we could get bipartisan support for it. And we could lower drug costs. We can stop the gaming in the system. And we can continue to have more cures in America, not less. And, let's face it--I do not believe it is an overstatement to say people will die if we have fewer cures. We know that to be a fact. It is not just a talking point. It is a fact. It is a truth. And in a time when we should rely on more facts, this is one we should think about seriously before we vote on H.R. 3. That is why, Mr. Chairman, we came up with this combination of really thoughtful proposals, some of which have passed out of committees in the House or in the Senate--bipartisan support for them. Now, on the Peters amendment itself: It is a laudable amendment. It will not be able to substitute for the destruction, however, of the American biomedical industry under H.R. 3. The Congressional Budget Office says the effects on the new drug introductions from increased Federal spending under the bill on biomedical research would be modest. That is CBO. I will let our Members vote as they want. Certainly, we all want to do more to invest in our National Institutes of Health. I have no real objection to the gentleman's amendment, but the underlying bill eviscerates what he is trying to accomplish here in terms of medical research and breakthrough cures. Mr. Chairman, with that, I yield back the balance of my time.

Mr. WALDEN. Mr. Chairman, I claim the time in opposition.

Mr. WALDEN. Mr. Chairman, I recognize the serious impact prescription drug prices have on all Americans. We all have constituents facing the same problem: drug prices are too high. We all want to come together to find a way to lower drug prices. Where we separate is our proposal would lower drug prices, put a cap on what seniors pay, and, for the first time, in Medicare part D, reduce their insulin costs but not end the kind of incredible innovation in America we see today. It would not cost 88,000 American innovators their jobs, and it would not reduce this innovation that is producing two-thirds of the world's cures. Unfortunately, H.R. 3 would do that. H.R. 3--the underlying bill that is a very disappointingly partisan bill--would cost patients cures to their diseases. We know that. It is not my conclusion. These are the people who innovate in this space. These are Congressional Budget Office analysts and the Council of Economic Advisers. There has not been a single piece of evidence presented on this floor that says that H.R. 3 will do anything but reduce investment and outcome of overall new cures. In fact, a colleague of mine and I were talking during the last amendment debate. In effect, we are trading $1 trillion in private- sector investment in new innovation in America for medical cures for $100 million--in this case, the Peters amendment--in taxpayer money. So you are trading $100 million for $1 trillion, and $1 trillion is private-sector investment coming in, because we know a lot of these new paths that our innovators pick to go down to find a cure just simply end up being a dry hole and all that money is lost. So it takes a lot to find a cure, but we stand on the cusp of something big and bold, and that is cures for diseases where there is none today. We do have a problem in America trying to figure out how to pay for that. I am going to be retiring at the end of this Congress, and I know my colleague is going off to the Senate at the end of this Congress if voters in Massachusetts have their way, but together, we still, as a country, have to come together and figure out with precision medicine that may produce a cure for you and you only: How are we going to pay for that? We don't have a lot of answers. I don't think giving the government the biggest club in history to take 95 percent of revenues if you don't agree with what the government wants to pay for something is the right approach. That is what H.R. 3 does. We know it takes $1 trillion out of the pipeline of investment in innovation in America and costs 80-some thousand jobs in innovation. But in terms of the Jackson Lee amendment which was so ably brought and described by Mr. Kennedy, I share the concern about what the costs of medicines are putting as a burden on people, especially in rural areas. My district would stretch from the Atlantic to Ohio--we could put a lot of Massachusetts in my district--and our people are suffering. So I look forward to a day when, after our substitute becomes law, we can continue to work together on these other issues. I hope my friend will support our substitute because I think it is all bipartisan; 138 Democrats have supported provisions in our substitute amendment. There isn't a single partisan poison pill in our substitute amendment. I think that is why it is attracting support on both sides of the aisle. Mr. Chairman, I know we have a lot of business to do. I appreciate Mr. Kennedy bringing this to the floor on behalf of Ms. Jackson Lee, and I yield back the balance of my time.

Mr. WALDEN. Mr. Chairman, I claim the time in opposition.

Mr. WALDEN. Mr. Chairman, I thank the gentleman for offering his amendment today, and I really do. We work a lot of with Mr. Gottheimer on a number of issues before the Congress, and I appreciate his commitment to this cause. Republicans fully support the goal of the amendment: to identify those diseases and conditions in which there is an unmet medical need and exploring ways to further incentivize getting treatments to market. In fact, a study in unmet medical needs is especially timely with the consideration of this underlying bill, H.R. 3, because we believe it will crush development and hope for new treatments. We are not alone. We have come to this conclusion based on others' factual evaluation of the bill. There is no shortage of sources warning us that H.R. 3 will lead to fewer cures. In fact, independently, the Council of Economic Advisers estimates as many as 100 new treatments will be lost over the next decade under the partisan H.R. 3. I think the most disturbing, Mr. Chairman, is that the California Life Sciences Association, the great innovators in America who come up with these new cures that we all are counting on, predicts an 88 percent reduction in the number of drugs brought to market by small and emerging companies. And that is only in California, apparently. The nonpartisan Congressional Budget Office, another source here, our third independent source, estimates that, under H.R. 3, we will have nearly 40 fewer drugs over, roughly, the next two decades; and then, after that, you would see an annual--every year--reduction of 10 percent in the number of drugs entering the market in the later years. That is what has led so many of us Republicans to oppose H.R. 3. We support the goal of getting drug prices down. We think there are other ways to do that, and we are open to working on those issues. No President has ever leaned further forward on this matter and taken the pharma companies' CEOs head on than President Trump. But even he, after reading through the bill, said it goes too far. And you can't sacrifice innovation and lifesaving cures for what else is in the bill. H.R. 3 will undoubtedly lead to an increase in patients with unmet medical needs, fewer drugs. Republicans believe the value of fostering innovation is essential, that is why we led on 21st Century Cures, and passed it into law, led by my friend from Michigan, Mr. Upton, and my friend from Colorado, Diana DeGette, a bipartisan effort. But we know there are diseases out there that still long for a cure. This is why our bipartisan solution to lower drug prices, the substitute amendment, H.R. 19, will lower costs, but also promote innovation, and promote it from the private sector side. We want that private venture capital money to continue to flow into this pipeline. H.R. 3, we are told, the independent analysis tells us, a trillion dollars in private sector money will leave this sector because the punishment is so harsh. Can you imagine, you are working your whole life, you have gone to college, you have got this great degree, this big brain, you are coming up with a solution to ALS or something, you finally get it done. It goes through all the trials. It is perfected. It works. You get a patent. And then the government says, We are going to set the price, and if you don't agree to that price, we are going to take 95 percent of the revenues for wherever else you sell this. By the way, Congressional Research Services warned Congress, and we have had other constitutional experts tell us for sure, H.R. 3 is so punitive and so unfair, it would violate the Fifth Amendment of the Constitution and the Eighth Amendment of the Constitution. So the underlying bill, as we have been told, is unconstitutional. We all stand down here and take an oath of office to uphold the Constitution. We are being told by our own Congressional Research Service it likely upends, is in violation of, the Constitution. We have other experts say for sure it is. I appreciate the gentleman's amendment. I do. We know there are unmet needs that need to be dealt with. I think it makes a lot of sense. Mr. Chairman, I reserve the balance of my time.

Mr. WALDEN. Mr. Chairman, may I inquire how much time I have remaining?

Mr. WALDEN. Mr. Chair, I yield myself such time as I may consume. Again, I appreciate the gentleman's hard work on this issue. I know we share a common goal of getting drug prices down and meeting unmet needs of cures. But, tragically, the Democrat bill, H.R. 3, is a very partisan bill. We are told by the California Life Sciences Association that, if enacted, you could see an 88 percent reduction in the number of drugs brought to market by small and emerging companies in California alone. That is their estimate. These are the people who do this work. They also estimate we would lose 80,000--that is a lot--80,000 biotech R&D jobs nationwide. That is what H.R. 3 does. So, if you are for cutting jobs in America in biotechnical research, and if you are for 88 percent fewer drugs coming to market from small and emerging innovators in California, then I guess you are going to vote for H.R. 3. I am not going to. I think we can do better. Mr. Chairman, I yield back the balance of my time.

Mr. WALDEN. Mr. Chair, I demand a recorded vote.

Mr. WALDEN. Mr. Chairman, I rise in opposition to this amendment.

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

Mr. WALDEN. Mr. Chair, we certainly support clinical trials at the National Institutes of Health. In fact, the Republicans have led on this issue. In fact, Republicans have led for decades in increasing the funding for NIH, going clear back to about 1995 when then-Speaker Gingrich led an effort to double the funding for the NIH. Our colleague Mr. Upton from Michigan led the effort to dramatically increase the funding for NIH. We know that is extraordinarily important to do. Of course, while that is important, it is kind of the basic science. The real work that gets done takes that and then turns it into drugs eventually through a whole clinical trial process with lots more innovation and investment. Tragically, H.R. 3 rips $1 trillion out of that innovation funding cycle. That is why, for the life of me, I can't understand why my friends are voting for that knowing that, and how they can vote for H.R. 3 knowing that upward of 100 or more cures, lifesaving drugs, medicines never will be developed. Those aren't my numbers. Those are the numbers of the Council of Economic Advisers. Those are the numbers from CBO. They tell us in literally the next 20 years, 38 new drugs will never be developed, at a minimum, upward of 38. It could be more. I suppose it could be less. After that, it is 10 percent every year that don't get developed. We think it is actually higher than that, but those are the facts. Those are facts. I want to emphasize that the ban on spread pricing in Medicaid offered here as a Democratic amendment is actually, as my friend recognizes, in H.R. 19. We agree. There are 138 Democrats who have sponsored different provisions that are bipartisan in the substitute amendment, and it should do no damage. Why would you vote against your own stuff? I mean, it is in here. It is good policy. It is bipartisan. I hope that some will have the opportunity to be strong and vote for really good bipartisan legislation. I would argue that H.R. 19, the substitute, is the most bipartisan bill on the floor today, the only bipartisan bill on the floor today. This comprehensive collection of bipartisan policies from both the House and the Senate are contained in the substitute, H.R. 19. We looked a lot at the work that Senator Grassley and my own State Senator Ron Wyden put together in their legislation. We probably got 90 percent of that one way or the other incorporated in here. I have learned over the years, from the time I got here as a freshman until now, you don't get everything. Sometimes, you can make more progress by getting together and getting what you can agree on done and then continuing to work on the issues where you don't agree, and I would say that is an issue that we face right now. We have before us a substitute that could become law, and the President basically indicated he would sign it. He clearly has indicated he will veto H.R. 3. We have had word out of the Senate that they have no plans to take up H.R. 3. To me, it makes it a nonstarter. I also believe it is dangerous to innovation. It will cost 88,000 jobs U.S.-wide, and 80-something percent of new drugs coming out of California won't be developed. That is according to the people who do this work, California Life Sciences. I don't think you have to trade that reduction in innovation and new cures for lower prices. I think you can actually have both. We have a common commitment here to lower drug prices. We have a common commitment here to increase investment in NIH and to stop the bad behaviors by the pharmaceutical companies, to stop them from withholding samples so that generics don't get to market or actually paying all generic brands not to come to market. I wrote the legislation last Congress that modernized the FDA's approval process for medical devices, generic devices, so we couldn't get stuck--that is a bit of a pun--by another EpiPen issue. Because there was no competitor, they raised the price the way they wanted to, and they stuck it to people like my wife, who used to use an EpiPen, and many other consumers. We now have competition in that space, and the FDA has approved more generic drugs as a result of our unanimous work on the FDA reform. More generic drugs in the last year than at any time in the history of the FDA were approved, over 1,100 new generic drugs, because, I think, when you get more competition in the market, consumers benefit with more choice and lower price. Now, there is still some gaming that goes on, and we agree on that, and we are putting a stop to that wherever we can find it. But I don't want to vote for H.R. 3 as an unconstitutional measure, as we have been warned by our own Congressional Research Service lawyers who looked at it. They said it likely violates two provisions of the Constitution because it is so punitive and damaging. We had the outside science people look at it and say it is going to cost cures. Mr. Chair, I yield back the balance of my time.

Mr. WALDEN. Mr. Speaker, on that I demand the yeas and nays.

Mr. WALDEN

Mr. WALDEN. Mr. Chair, I yield myself such time as I may consume. Mr. Chair, let me be clear: Drug costs in America are too high. Republicans believe this, and so do Democrats. We all should work together, though, to lower drug costs for consumers. We all should work together to stop anticompetitive actions of pharmaceutical companies that try to game the system and delay access to lower cost alternative medicines. And we should all work together--together, Mr. Chair--to pass legislation that both lowers drug costs, without killing off medical innovation. Unfortunately, H.R. 3 fails on this count. And that is not just my conclusion, Mr. Chair. The great American innovators who are working day and night to find cures to Alzheimer's, to cancer, to ALS, to Parkinson's, and the hundreds of other diseases and life-changing therapies are pleading with us for a ``no'' vote to H.R. 3--the Democrats' plan. Mr. Chair, 138 different biotech companies signed a letter to Congress 5 days ago. After reading the bill, they wrote: ``This extreme proposal will upend the ecosystem of U.S. biomedical innovation, destroying our ability to attract private sector investment.'' These are the companies who develop the new innovations in medicine. They said H.R. 3 will shatter the dreams of patients hoping for lifesaving cures. Mr. Chair, I include in the Record the letter in support from those companies. December 5, 2019. Hon. Nancy Pelosi, Speaker of the House, Washington, DC. Hon. Kevin McCarthy, House Republican Leader, Washington, DC. Dear Speaker Pelosi and Republican Leader McCarthy: We represent the community of emerging biotechnology companies whose researchers and scientists strive daily to develop innovative life-changing therapies and cures for patients. We take pride that we are providing hope to patients and their families and changing the world through medical breakthroughs. These dreams will be shattered if H.R. 3, the Lower Drug Costs Now Act, if passed. We are at an incredible inflection point in science and technology that is bringing forth transformative treatments and even cures for cancer, infectious diseases, and a myriad of other serious and rare diseases. These advancements are benefiting lives of millions of patients and alleviating human suffering, while helping to reduce other more expensive parts of our health care system, such as hospital spending. Our continued success depends on maintaining an environment that supports investment in tomorrow's discoveries. Unfortunately, H.R. 3 is an unprecedented and aggressive government intervention in the U.S. market of drug development and delivery that will limit patient access to these extraordinary advancements in health care. This extreme proposal will upend the ecosystem of U.S. biomedical innovation, destroying our ability to attract private investment dollars that allow us to develop new treatments and change the course of healthcare delivery for so many patients. We strongly urge you to abandon H.R. 3. Further, in order to keep pace with this biomedical revolution and ensure America remains the world leader in innovation, we hope that you will pursue bipartisan, holistic policies that modernize our health care payment system and lower drug costs for patients. Sincerely, Adelene Perkins, Chair & CEO, Infinity Pharmaceuticals, Inc.; Adrian Gottschalk. President & CEO, Foghorn Therapeutics; Alden Pritchard, CEO, Kaio Therapy, Inc.; Alex Nichols, PhD. President & CEO, Mythic Therapeutics; Amit Munshi, President & CEO, Arena Pharmaceuticals, Inc.; Andre Turenne, President & CEO, Voyager Therapeutics. Inc.; Aprile Pilon, PhD, President & CEO, Trove Therapeutics, Inc.; Armando Anido, Chairman & CEO, Zynerba Pharmaceuticals; Axel Bolte, Co-Founder, President & CEO, lnozyme Pharma; Barry Quart, President & CEO, Heron Therapeutics; Bassil Dahiyat, President & CEO, Xencor, Inc.; Bill Enright, CEO, Vaccitech, Ltd.; Bill Newell, CEO, Sutro Biopharma; Blake Wise, CEO, Achaogen, Inc.; Bonnie Anderson, Chairman & CEO, Veracyte, Inc.; Bradford Zakes, President & CEO, Cerevast Therapeutics; Brandi Simpson, CEO, Navigen, Inc.; Brian Windsor, CEO, Lung Therapeutics, Inc. Briggs W. Morrison, MD, CEO, Syndax Pharmaceuticals; Bruce Clark, PhD, President & CEO, Medicago, Inc.; Casey Lynch, CEO, Cortexyme; Cedric Francois. Co-Founder, CEO & President, Apellis Pharmaceuticals; Chris Gibson, Co-Founder & CEO, Recursion; Christopher Barden, CEO, Treventis Corporation; Christopher Burns, PhD, President & CEO, VenatoRx Pharmaceuticals, Inc.; Christopher Schaber, President & CEO, Soligenix, Inc.; Ciara Kennedy, PhD, CEO, Amplyx Pharmaceuticals; Clay Seigall, President, CEO & Chairman, Seattle Genetics, Inc.; Craig Chambliss, President & CEO, Neurelis; David Baker, President & CEO, Vallon Pharmaceuticals; David Bears, Founder & CEO, Tolero Pharmaceuticals; David de Graaf, PhD, President & CEO, Comet Therapeutics, Inc.; David Donabedian, PhD, Co-Founder & CEO, Axial Biotherapeutics; David Lucchino, President & CEO, Frequency Therapeutics, Inc.; David Mazzo, President & CEO, Caladrius Biosciences. David Meeker, CEO, KSQ Therapeutics; Doug Kahn, Chairman & CEO, TetraGenetics, Inc.; Douglas Doerfler, President & CEO, MaxCyte, Inc.; Dr. Elizabeth Poscillico, President & CEO, EluSys Therapeutics, Inc.; Eric Dube, PhD, CEO, Retrophin, Inc.; Eric Schuur, President & CEO, HepaTx Corporation; Erika Smith, CEO, ReNetX Bio; Franciso LePort, Founder & CEO, Gordian Biotechnology; Gail Maderis, President & CEO, Antiva Biosciences; Gary Phillips, President & CEO, Orphomed, Inc.; Geno Germano, President & CEO, Elucida Oncology, Inc.; George Scangos, CEO, VIR Biotechnology; Gil Van Bokkelen, Founder, Chairman & CEO, Athersys, Inc. Greg Verdine, President & CEO, LifeMine Therapeutics, Inc., FOG Pharmaceuticals, Inc.; Imran Alibhai, CEO, Tvardi Therapeutics; James Breitmeyer, President & CEO, Onctemal Therapeutics, Inc.; James Flanigon, CEO, Honeycomb Biotechnologies. James Sapirstein, President & CEO, AzurRx BioPharma; Jay Evans, President & CEO, Inimmune Corporation; Jeb Keiper, CEO, Nimbus Therapeutics; Jeff Cleland, PhD, Executive Chair, Orpheris, Inc.; Jeff Jonker, President & CEO, Ambys Medicines; Jeff Kindler, CEO, Centrexion Therapeutics; Jeremy Levin, Chairman & CEO, Ovid Therapeutics, Inc.; Joe Payne, President & CEO, Arcturus Therapeutics, Inc.; John Crowley, Chairman & CEO, Amicus Therapeutics, Inc.; John Jacobs, President & CEO, Harmony Biosciences; John Maraganore, CEO, Alnylam Pharmaceuticals; Julia Owens, President & CEO, Millendo Therapeutics, Inc.; Justin Gover, CEO & Executive Director, Greenwich Biosciences; Keith Dionne, CEO, Casma Therapeutics; Keith Murphy, Founder, CEO & President, Viscient Biosciences; Ken Mills, CEO, REGENXBIO, Inc.; Ken Moch, President & CEO, Cognition Therapeutics; Kent Savage, CEO, PhotoPharmics, Inc. Kevin Gorman, CEO, Neurocrine Biosciences; Kiran Reddy, MD, CEO, Praxis Medicines; Lawrence Brown, CEO, Galactica Pharmaceuticals; Lorenzo Pellegrini, Founder, Palladio Biosciences; Marc De Garidel, Chairman & CEO, Corvidia Therapeutics; Marilyn Bruno. PhD, CEO, Aequor, Inc.; Mark Leuchtenberger, Executive Chairman, Aleta Biotherapeutics; Mark Pruzanski, MD, President & CEO, Intercept Pharmaceuticals, Inc.; Mark Timney, CEO, The Medicines Company; Markus Renschler, MD, President & CEO, Cyteir Therapeutics; Martin Babler, CEO, Principia Biopharma; Melissa Bradford-Klug, CEO, Mayfield Pharmaceuticals; Michael Clayman, MD, CEO, Flexion Therapeutics; Michael J. Karlin, Co-CEO, Ibex Biosciences, LLC; Michael Raab, CEO, Ardelyx, Inc.; Mike Narachi, President & CEO, Coda Biotherapeutics; Ming Wang, PhD, President & CEO, Phanestra Therapeutics, Inc.; Morgan Brown, Executive VP & CFO, Lipocine. Nancy Simonian, CEO, Syros Pharmaceuticals; Olin Beck, CEO, Bastion Biologics; Pam Randhawa, President & CEO, Empiriko Corporation; Pat McEnany President & CEO, Catalyst Pharmaceuticals, Inc.; Paul Bolno, MD, CEO, Wave Life Sciences; Paul Boucher, President & CEO, Parion Sciences, Inc.; Paul Hastings, CEO, Nkarta Therapeutics; Paul Laikind, President & CEO, Viacyte; Peter Savas, CEO & Chairman, LikeMinds, Inc.; Rachel King, Founder & CEO, GlycoMimetics, Inc.; Randy Milby, Founder & CEO, Hillstream BioPharma, Inc.; Rashida Karmali, PhD, President & CEO, Tactical Therapeutics, Inc.; Richard Markus, CEO, Dantari Pharmaceuticals; Richard Pascoe, Chairman & CEO, Histogen, Inc.; Richard Samulski, President, Asklepios BioPharmaceutical, Inc.; Rick Russell, President, Minverva Neurosciences; Rick Winningham, Chairman & CEO, Theravance Biopharma; Rob Etherington, President & CEO, Clene Nanomedicine. Robert Goodwin, PhD, CEO, Vibliome Therapeutics, Inc.; Robert Gould, PhD, President & CEO, Fulcrom Therapeutics; Robert Bernard, President & CEO, Ichor Medical Systems; Robert Wills, Chairman, CymaBay Therapeutics. Inc.; Roger Tung, President & CEO, CoNCERT Pharmaceuticals; Ron Cohen, Founder, President & CEO, Acorda Therapeutics, Inc.; Russ Teichert, PhD, CEO, Scintillant Bioscience; Russell Herndon, President & CEO, Hydra Biosciences, LLC; Samantha S. Truex, CEO, Quench Bio; Sandy Macrae, President & CEO, Sangarno Therapeutics, Inc.; Scott Koenig, President & CEO, MacroGenics, Inc.; Sean McCarthy, President, CEO & Chairman, CytomX; Sharon Mates, Founder, Chairman & CEO, Intra-Cellular Therapies; Shawn K. Singh, CEO, VistaGen Therapeutics, Inc.; Stan Abel, President & CEO, SiteOne Therapeutics, Inc.; Stanley Erck, President & CEO, Novavak. Stephen Farr, PhD, President & CEO, Zogenix, Inc.; Stephen R. Davis, CEO, ACADIA Pharmaceuticals; Stephen Yoder, CEO, & President, Pieries Pharmaceuticals; Sue Washer, President & CEO, AGTC; Sujal Shah, President & CEO, CymaBay Therapeutics, Inc.; Ted Love, CEO, Global Blood Therapeutics; Terry Tormey, CEO, Kibow Biotech; Thomas Wiggans, Founder, President & CEO, Dermira, Inc.; Tia Lyles-Williams, Founder & CEO, LucasPye BIO; Tim Bertram, CEO, inRegen & TC Bio; Timothy Walbert, President & CEO, Horizon Therapeutics; Todd Brady, CEO, Aldeyra Therapeutics; Vipin Garg, PhD, CEO, Altimmune; Wendye Robbins, MD, President & CEO, Blade Therapeutics; Will DeLoache, CEO, Novome Biotechnologies; Zandy Forbes, CEO, MeiraGTx.

Mr. WALDEN. Mr. Chair, the Congressional Budget Office, they also looked at H.R. 3, Speaker Pelosi's bill, and they said it would kill off more than 38 new medical innovations--38. The Council of Economic Advisers, they looked at it and said they thought it would be more like 100 new medicines that would be lost. It is no wonder that President Trump, the country's strongest advocate for lowering drug prices, said even he could not support H.R. 3, and would have to veto it. Mr. Chair, I include in the Record the Statement of Administration Policy. Statement of Administration Policy h.r. 3--the elijah e. cummings lower drug costs now act--rep. pallone, d-nj, and 106 cosponsors The Administration opposes passage of H.R. 3, which contains several provisions that would harm seniors and all who need lifesaving medicines. Nevertheless, as Congress follows the President's lead on reducing prescription drug costs, the Administration welcomes bipartisan efforts to enact legislation that provides additional prescription drug- cost relief for American families. In its current form, H.R. 3 would likely undermine access to lifesaving medicines. The bill creates a statutory scheme for ``negotiation'' between the Secretary of Health and Human Services and pharmaceutical manufacturers regarding the price of prescription drugs, but the penalty for failing to reach agreement with the Secretary is so large that the Secretary could effectively impose price controls on manufacturers. Moreover, this price-fixing mechanism places price controls on drugs available under Medicare and commercial plans, and imposes devastating fines on manufacturers, raising serious concerns under the Fifth Amendment's Takings Clause and Eighth Amendment's Excessive Fines Clause. This bill would also compromise the health of Americans by dramatically reducing the incentive to bring innovative therapeutics to market. The preliminary Congressional Budget Office (CBO) analysis indicates that the bill would reduce the number of new medicines coming to market. The Council of Economic Advisers (CEA) finds that H.R. 3's price controls would affect as much as one third of drugs under development, meaning that out of 300 projected new medicines that would otherwise be approved over 10 years by the Food and Drug Administration, 100 could be severely delayed or never developed. As a result, CEA estimates H.R. 3 would erase a quarter of the expected gains in life expectancy in the United States over the next decade. The preliminary CBO analysis of H.R. 3 does not account for the additional costs that would burden families and the Federal Government due to the unavailability of lifesaving and cost-reducing medicine that would otherwise exist. For example, an Alzheimer's cure, or new treatments for site specific cancers or diabetes, may be delayed or never developed under the regime imposed by H.R. 3. Thus, the cost of caring for a growing and aging population with direct care, skilled nursing, and home health could be substantially greater than the drug-cost savings estimated by CBO. More importantly, the effects of these cost increases on individuals and their families will be significant, personal, and long-lasting. This legislation does include important policies championed by the Trump Administration to lower prescription drug costs. These include establishing a cap on out-of-pocket expenses for all beneficiaries in Medicare Part D and simplifying and improving that program. H.R. 3 also would limit annual price increases of certain drugs in Medicare to the rate of inflation, protecting beneficiaries and taxpayers from excessive price hikes. These provisions reflect the Administration's priorities, although modifications should be made to strike a better balance in protecting beneficiaries, taxpayers, and innovation. The Administration strongly prefers the Prescription Drug Pricing Reduction Act of 2019, which was reported out of the Senate Finance Committee on a bipartisan basis. This legislation offers a sound approach to delivering relief to seniors from high prescription drug costs while safeguarding the ongoing development of life-saving and sustaining medicines. Additionally, H.R. 19, the Lower Costs, More Cures Act, shares many of the same bipartisan elements of the Prescription Drug Pricing Reduction Act and is also a far better approach to lowering drug prices and discovering life- saving cures than H.R. 3. The President believes there is a path forward to enacting bipartisan legislation that lowers prescription drug costs for American families. The Administration remains committed to working with both parties to pass legislation that will lower drug costs while encouraging innovation in the development of lifesaving medicines. If H.R. 3 were presented to the President in its current form, he would veto the bill.

Mr. WALDEN. Mr. Chair, my friends on the other side, the Democrats, ignore these facts. Some have even said--can you imagine this--that it is ``worth it'' to forego cures. Seriously? That it is worth it to never have a cure for Alzheimer's? Is it worth it to never have a cure for ALS? What about Huntington's Disease, or Parkinson's, or rheumatoid arthritis? The answer for me is ``no,'' because one lost cure is one too many. The Independent Congressional Research Service also read through H.R. 3. They said it is unconstitutional, most likely because of the huge and punitive club that it hands the government. You see, if an innovator, under the bill on the floor today that the Democrats have, if an innovator does not agree with the price that the government demands, then the government can take 95 percent of that company's revenues for the sale of that drug--95 percent. Oh, by the way, it is actually higher than that because you can't deduct it and they have to pay tax. Democrats call that a negotiation. I call that a mugging, Mr. Chair, a mugging. Their scheme is based on what happens with drugs in six other countries. And they ignore that in these referenced countries and other countries around the world, people are actually denied access to lifesaving medicines that Americans have access to. So this is the tradeoff here. If you remember nothing else, it is that we first get access to medicines, and in the countries the bill would emulate and copy and bring the process here, you don't get access to some of these lifesaving drugs that Americans do here. That is your trade. Let me tell you about the family of Katie Stafford: She is a child living with cystic fibrosis in the United Kingdom. She was told by officials she cannot receive the medicine that her doctor determined would be the best chance at treating her life-threatening condition, because they don't cover it in the United Kingdom under their system. Let me tell you about Andre and Joshua: They are Canadian brothers, tragically both suffering from cystic fibrosis. Their parents had to beg the Canadian Government to cover treatment for their sons as they slowly lose their lung function. Now, their oldest son is enrolled in a clinical trial that the youngest son is ineligible for. So they must watch as one child gets help and the other child's health declines. Fortunately, Mr. Chair, American children have access to this new medicine. We cannot allow this to happen in the United States. Denial of care is not an American value. But I want to be clear: We all agree that Americans do pay too much for prescription drugs, and we need to come back together as Republicans and Democrats to help solve this issue. There is a better way, because we can reduce the cost of drugs. We can improve healthcare, and we can lower long-term costs, but we don't have to do it at the expense of great American innovation while restricting patient's access to lifesaving medicines. There is a way to do this. In fact, Members will have an opportunity to support, really, the only bipartisan legislation to come to the floor, H.R. 19. You will see it as a substitute, the Lower Costs, More Cures Act, which we will offer as a substitute amendment, is the bipartisan solution. It can be signed into law this year--this year-- not vetoed, not never gain attention in the Senate like H.R. 3 will find itself, if it gets there, but this can become law. This is where we can join together and immediately begin to provide relief to patients and seniors from high prescription drug costs. This bill lowers out-of-pocket spending, protects access to new medicines and cures, strengthens transparency and accountability, and champions competition and innovation. And most importantly, every single proposal, Mr. Chair, every single proposal in H.R. 19, the substitute, is bipartisan work--Democrats and Republicans. We give you this option. This is a serious proposal. It has been described that way. It could be signed, would be signed into law by the President by the end of this year. So let's not force a partisan plan that, frankly, puts politics over progress, that kills medical innovation and cures. Instead, can't we come together and pass meaningful bipartisan legislation, get it across the finish line and actually find lower costs and more cures for Americans? Mr. Chair, I reserve the balance of my time.

Mr. WALDEN. Mr. Chair, I yield 1 minute to the gentleman from Ohio (Mr. Latta).

Mr. WALDEN. Mr. Chairman, I include a list of the drugs not covered by the VA into the Record. They only cover 24 of the top 50 nonvaccine Medicare part B drugs on the VA formulary. I also include a list of available medications in H.R. 3 reference countries. Top Medicare Part B Drugs NOT Covered by the VA (excluding vaccines) brand name/generic name Remodulin/Treprostinil Sodium Provenge/Sipuleucel-T/Lactated Ringers Soliris/Eculizumab Synvisc/Hylan G-F 20 Tyvaso/Treprostinil Abraxane/Paclitaxel Protein-Bound Actemra/Tocilizumab Advate/Antihemophil.FVIII, full Length Aloxi/Palonosetron HCL Brovana/Arformoterol Tartrate Budesonide/Budesonide Entyvio/Vedolizumab Erbitux/Cetuximab Faslodex/Fulvestrant Injectafer/Ferric Carboxymaltose Kadcyla/Ado-Trastuzumab Emtansine Neulasta/Pegfilgrastim NPlate/Romiplostim Orencia/Abatacept Prolia/Denosumab Remicade/Infliximab Simponi Aria/Golimumab Xolair/Omalizumab Yervoy/Ipilimumab

Mr. WALDEN. Mr Chairman, I yield 1 minute to the gentleman from North Carolina (Mr. Hudson).

Mr. WALDEN. Mr. Chairman, I yield 1 minute to the gentleman from Illinois (Mr. Shimkus), an incredible, important member of our committee.

Mr. WALDEN. Mr. Chairman, I yield 2 minutes to the gentleman from Texas (Mr. Burgess), the top Republican on the Health Subcommittee of the Energy and Commerce Committee.

Mr. WALDEN. Mr. Chairman, I yield 1 minute to the gentleman from Kentucky (Mr. Guthrie), the top Republican on the Oversight and Investigation Subcommittee of the Energy and Commerce Committee.

Mr. WALDEN. Mr. Chairman, I yield 1 minute to the gentleman from West Virginia (Mr. McKinley), an important member of our committee.

Mr. WALDEN. Mr. Chairman, I want to say that we cannot lose sight of how anti-innovation H.R. 3 is. We cannot lose sight of how many cures will never come around as a result. These aren't my conclusions. They are, but they are also the conclusions of the Congressional Budget Office and the Council of Economic Advisers. Hundreds of new drugs will never come to market. Medicines will never be created. We know that 10 percent fewer drugs will enter the market every year in the 2030s and every year thereafter as a result of H.R. 3. This bill will leave people behind. It will result in earlier deaths than otherwise should happen. Mr. Chairman, I yield 1 minute to the gentleman from Virginia (Mr. Griffith).

Mr. WALDEN. Madam Chair, I yield myself such time as I may consume. Madam Chair, I would point out that the Republican alternative also caps costs for seniors, again, for the first time. We believe there is a place where that needs to happen for our seniors. In the committee, Republicans offered up an amendment that would have taken all the middleman profits, the rebates, and put them toward making insulin at no cost for seniors at the pharmacy counter. Unfortunately, every Democrat on the committee voted against that. Why, I do not know, but they did. We want more cures and we want lower costs. We can have both. There is no dispute among us, Republicans and Democrats, that drugs are too high. The question is: Can we find a scheme that is constitutional, and does it eliminate cures for diseases that people are relying on and shut down innovation in America? I think we can, by the way. I think that is H.R. 19. We will deal with that later. Madam Chair, I yield 1 minute to the gentleman from Ohio (Mr. Johnson).

Mr. WALDEN. Madam Chair, I yield myself such time as I may consume. Madam Chair, I just want to point out a couple of things. First of all, what is really unacceptable is to kill off American innovation in this space. We know from the biotech people who are doing this innovation, they have written us saying it will shatter the hopes and dreams of Americans waiting for cures. It will completely upend the ecosystem of innovation. America is where the innovation occurs. We don't think that has to happen to bring down the costs of drugs, which we also support. We also don't think you should end up in a system like this where, in these countries that they want to emulate, like Australia, Canada, France, Germany, Japan, and the United Kingdom, all new medications that we have here, they only have between 30 and 60 percent. In fact, in cancer, there are 27 to 50 percent fewer cancer drugs in these countries. There is a range here, Madam Chair, that are available. So, if you get cancer, if you were in America here, you might get a drug that would prolong your life or cure your cancer. In these countries, you have a run of 27 to 50 percent chance you won't get that drug; diabetes, 10 to 50 percent fewer; respiratory, 17 to 50 percent fewer. They, in part, control their costs because they deny access to care of the lifesaving new cutting-edge drugs that we innovate. Madam Chair, I yield 1 minute to the gentleman from Michigan (Mr. Walberg), a very important member of our committee.