Lower Drug Costs Now Act of 2019
Floor Speech
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Mr. UPTON. Madam Chair, I thank the gentleman for yielding.
I thank the Democratic leadership for, I think the first time this year, allowing our side to actually have a substitute to a major piece of legislation. And I thank our leadership, because that substitute is not a partisan substitute but, rather, a bipartisan substitute. In fact, every single provision in this bill has got strong bipartisan support, which was packaged together.
Tomorrow will mark the third anniversary of President Obama's signing of 21st Century Cures, a bill that Diana DeGette and I helped shepherd through our committee on a unanimous vote, and we passed here in the House 392-26.
21st Century Cures increased NIH funding by some $45 billion over a 10-year span. It sped up the approval of drugs and devices, and just after 3 years we have seen the number of cell, gene, and nucleoid therapies have more than doubled. In fact, research this last year will actually exceed $13 billion. The FDA is predicted to approve as many as 20 gene therapy drugs by the year 2025. That is wonderful news.
We all want to do something about drug prices, and that is what a vote for our substitute, H.R. 19, will do. The President will sign that bill, but he is not going to sign this bill, H.R. 3, because it is going to slow down the ability to find the cures that we want to find for these awful diseases.
Now, those aren't my words. That is the CBO, a nonpartisan group, it is the CEA, the Council of Economic Advisers.
But in today's ``Wall Street Journal,'' the former director of the FDA, Scott Gottlieb, writes, ``This week the House will vote on legislation known as H.R. 3. The price-control approach would increase uncertainty and reduce returns from biotech investment, raising the cost of capital for these invaluable endeavors.'' He is right on. We want to find new cures. We want to find new technologies and to use those. We want precision medicine.
Madam Chair, I include the ``Price Controls Would Stifle Biotech Innovation'' in the Record. Price Controls Would Stifle Biotech Innovation
A House price-control bill would do the most damage to transformative and lifesaving medications. (By Scott Gottlieb, Dec. 11, 2019)
Victoria Gray of Mississippi recently became the first U.S. patient with a genetic disorder to be treated using the Crispr gene-editing technique. Doctors used a novel drug to overwrite the function of a faulty gene that gave rise to her sickle-cell disease. Advances in life science can define this century, but policy makers must resist the urge to adopt policies that impose price controls and punish drugmakers for taking risks.
The convergence of information technology and biology allows scientists to translate the human genome into digital data that can accelerate diagnoses and cures. Over the next decade, it is a near certainty that we will have gene-therapy cures for deadly inherited disorders such as muscular dystrophy. Cell-based and regenerative medicine can restore human functions lost to disease, including returning some sight to the blind. Gene editing will be used to alter DNA to erase the origins of a range of debilitating inherited disorders.
These are only some of the opportunities at hand. Yet bad policies could sap the risk-taking that brings forth the most important innovations. For instance, the Lower Drug Costs Now Act would expose the 250 costliest drugs to government price controls. The high-cost drugs lawmakers target are often the most innovative and potentially transformative new medications. This week the House will vote on the legislation, known as H.R. 3.
The price-control approach would increase uncertainty and reduce returns from biotech investment, raising the cost of capital for these invaluable endeavors. It would alter incentives and shift money from the most speculative but highest-value science, including regenerative medicine and gene editing. Money would flow instead to known disease areas and well-characterized targets, using proven approaches such as pill-form drugs.
New and high-risk drug platforms like gene therapies are often targeted first to treat rare and serious conditions; after they are proven to work safely, they will be used to treat morecommon maladies, such as heart disease. This is how medicine advances. But if investors knew their returns would be capped, they would direct their investments toward safer projects with lesser payoffs. We would still get new drugs, but the treatments would be very different.
Fifteen years ago, the standard refrain from drug-industry critics was that all the big drugmakers did was develop ``me too'' medicines--the seventh version of a blood-pressure pill or a cholesterol-lowering statin. In response, the federal government took steps, some of which shaped Medicare Part D, to encourage investment in ``specialty'' drugs that were more novel.
Since then, investment capital has shifted sharply. Cancer and rare diseases receive substantially more attention and resources. The number of cell, gene and nucleotide therapies in development has more than doubled over the past three years, while total investment in cell and gene therapies eclipsed $13 billion last year.
The Food and Drug Administration approved four gene therapies in only the past three years, with 800 similar kinds of products in various stages of development. An assessment of the current pipeline and historical rates of success in clinical trials suggests that by 2025 the FDA will be approving 10 to 20 gene-therapy drugs a year. Progress is especially strong in oncology. The number of cancer drugs in development has quadrupled since 1996.
These specialty drugs often aren't cheap. They target narrow conditions for which the cost of risk-taking and drug development is amortized over a smaller number of eligible patients. Highly novel drug platforms can also cost more initially to perfect. Based on my informal survey of companies, enrolling a single patient in a clinical trial for a gene-altering drug often costs between $500,000 and $700,000 and can reach as high as $1 million.
To support this innovation, total spending on research and development by the 15 biggest drugmakers topped $100 billion in 2018, up 32 percent in the past five years. A cancer cure, or a gene-therapy remedy, can sharply reduce the lifetime cost of treating a debilitating disease. It can dramatically alter the length and productivity of people's lives. But high-cost treatments are pricing out a growing number of underinsured patients, keeping them from using medications that could alter their providence. This is unacceptable.
There are ways to make specialty drugs more affordable without eroding the incentives that drive capital into the riskiest but most promising endeavors. One is to help second- to-market drugs get through the regulatory process.
Once an effective drug is approved to treat a deadly condition, introducing a second drug to treat the same disease can be hard. It's tough to recruit patients with a debilitating disease for a clinical trial when a proven medicine is already available. Moreover, the smaller pool of patients who will be newly diagnosed each year with the same disease isn't always large enough to support the cost of developing a second drug, reducing competition that can lower pnces.
We offer first-to-market breakthrough drugs an efficient route through FDA review. We could give second-to-market competing medicines the same regulatory benefits. Further, when the biology of a drug target is very well understood, and the basis for how it interacts with a disease firmly established, we can create a new regulatory designation to streamline development of a competing drug and shift data collection to real-world, post-approval settings.
Many drugs targeted by H.R. 3 for government price controls are examples of the innovation we should try to encourage. In fact, they are the investments that critics who griped about me-too medicines said they wanted. Now the same crowd is crafting policies that would shift investment back into the more mundane endeavors they once lamented.
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Mr. UPTON. Madam Chair, I have served on the Health Subcommittee for all my days on the Energy and Commerce Committee, and we have seen firsthand the different families impacted by these awful diseases, whether it be Alzheimer's or sickle cell, cystic fibrosis.
Just this last week, we witnessed real advancements, we think, in pancreatic cancer stage III, stage IV. SMA, spinal muscular atrophy, a disease that is often fatal by the year 9 or 10; we saw a woman who had been on a new drug for 15 days, and for the first time she could actually move her neck after more than 10 years literally trapped in a wheelchair.
If we want to find the advancements and cures for these diseases, we need to pass H.R. 19.
I urge my colleagues to vote for that substitute and get a bill to the President that he will actually sign, and we can get something done.
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Mr. UPTON. Mr. Chair, I seek time in opposition to the amendment.
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Mr. UPTON. Mr. Chair, I do rise in opposition to the amendment. I would like to make a couple of points.
According to the Office of Personnel Management, OPM, the FEHB program, the Federal Employee Health Benefits program, is, in fact, the largest employer-sponsored group health insurance program in the world. It covers nearly 9 million--9 million--Federal employees and their families.
This amendment says that any private health plan that chooses to offer coverage in the FEHB program must accept the government price controls for prescription drugs established under this bill, H.R. 3.
So, clearly, we are not satisfied in this amendment with only setting prices for Medicare and private businesses. It also creates another harmful mandate and expands the already-radical scope of H.R. 3 to other programs as well.
As my colleagues have noted again and again today and yesterday, governments don't negotiate; they dictate. Taxing up to 95 percent of a drug manufacturer's revenue if it refuses to agree with a government- mandated price is not free market negotiation.
And, as we have heard from both the CBO--nonpartisan body, Congressional Budget Office--and the CEA, they tell us that we are going to lose drugs that will solve cures, as they just won't happen with this bill.
Government price controls lead to lower and fewer cures; and, as the CEA said, nearly 100 cures for rare and difficult diseases likes Alzheimer's, ALS, and cancer just aren't going to happen, or they are going to be much delayed under H.R. 3.
So I would ask my colleagues to vote ``no'' on this amendment, and I reserve the balance of my time.
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Mr. UPTON. Mr. Chair, I yield myself the balance of my time.
I would also just like to say that the CRS, Congressional Research Service, has found that price controls in this bill, H.R. 3, the underlying bill, may be unconstitutional under the Fifth Amendment's Takings Clause and the Eighth Amendment Excessive Fines Clause.
So, instead of considering yet another amendment which expands radical government-mandated price controls at the expense of developing lifesaving cures, our time would be better spent considering bipartisan policies such as what is in the substitute, H.R. 19.
So I would encourage my colleagues to, instead, vote for the amendment on H.R. 19 and vote against H.R. 3.
Mr. Chair, I yield back the balance of my time.
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Mr. UPTON. Mr. Speaker, I have a motion to recommit at the desk.
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Mr. UPTON. I am in its current form.
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Mr. UPTON. Mr. Speaker, here is the beef: Tomorrow marks the third anniversary of the enactment of 21st Century Cures, a bill that passed this House at 392-26. In looking back at that legislation now, 3 years later, we have made wonderful strides in finding the cures for the diseases that have impacted every family, be it cystic fibrosis, Alzheimer's and pancreatic cancer, just to name a few.
And just last week, a number of us met with a young girl who had been in a trial for SMA. That is often a fatal disease known as spinal muscular atrophy. She was in a wheelchair, barely able to talk. But after 15 days on this trial, she could actually move her head and her neck for the first time in more than a decade, all really because of what we did on 21st Century Cures.
The CBO/CEA and Scott Gottlieb, in today's ``Wall Street Journal'' writes that H.R. 3, the underlying bill: ``The price-control approach would increase uncertainty and reduce returns from biotech investment, raising the cost of capital for these invaluable endeavors.''
You know, we are on the cusp of gene therapy for deadly inherited diseases like MS, literally, finding cures to solve blindness. But let's not stop. Let's build on what we did.
The language in this motion to recommit assures that cures will not be slowed down, because we have the requirement that unless the Secretary of HHS certifies the implementation of such provisions are not projected to result in fewer new drug applications. That is what this amendment is about.
We want to make sure that we have the resources to develop the cures that all of us want for the thousands of diseases where we don't have a cure.
Mr. Speaker, I would yield to the gentleman from Texas to talk about his personal story, that many of us did not know until this bill came up in the last couple of days.
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Mr. UPTON. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
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