May 8, 2019 - Issue: Vol. 165, No. 76 — Daily Edition116th Congress (2019 - 2020) - 1st Session
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Prescription Drug Costs (Executive Calendar); Congressional Record Vol. 165, No. 76
(Senate - May 08, 2019)
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[Pages S2716-S2717] From the Congressional Record Online through the Government Publishing Office [www.gpo.gov] Prescription Drug Costs Mr. CORNYN. Mr. President, yesterday the Senate Judiciary Committee held a very important hearing on how we can bring down prescription drug prices for American families without sacrificing the innovation that has made our country a world leader in new drug development. That is quite a challenging balance to strike. As I travel my State, I have heard from my constituents about their increasing inability to get their hands on the medications they need at a price they can afford--not because no treatment exists, not because they don't have insurance, and not even because it is a pricey, brandnew drug. Patients can't afford their prescriptions because the prices are going up at an alarming rate, with little evidence or justification to back some of the price hikes. I heard from one Texas pharmacist who was shocked by the dramatic price increase of drugs that had been available for years. She told me about one popular antibiotic that once cost $8 for 1,000 tabs. She said now it costs more than $1,200 for the same amount--$8 to $1,200. What is the justification for that? Well, we are left to wonder and speculate, and that is part of the reason for the investigation being undertaken now by the Finance Committee and other Senate committees. These costs have been so overwhelming that some of my constituents will cross the border to go to Mexico to try to buy prescription drugs there. A man from Rockport, TX, told me one of his prescriptions cost about $1,000 each month in the United States. But if he drives a few hours to Mexico, he can get what he thinks is that same medication from what he thinks is the same manufacturer for about $160--$1,000 versus $160. Of course, what we don't know is whether it is a counterfeit, whether it is not only ineffective to deal with the condition that he is taking the medicine for but whether it might poison him. So this is a challenging issue with no easy answers. I know one thing. I know my constituents are frustrated by these confusing price hikes. They don't understand the dramatic price differences from one retailer to another, and I have heard them loud and clear because I don't understand it either. We know that something needs to be done to rein in the high costs before medication becomes a luxury only for those who can afford it. Since the beginning of this new Congress, the Senate Finance Committee has held a series of hearings to examine what is behind these rising costs. We have heard from all of the major players in the supply chain and asked some long overdue questions. The Senate Judiciary Committee has begun looking into how to bring these prices down, specifically by stopping pharmaceutical companies who game the patent system. Patents play a very important role in our economy. They are recognized in the Constitution itself, and when somebody discovers something new and wonderful that helps improve all our lives, they are entitled to reap the benefits from that. Companies, we know, pour extensive time and funding into the research and development of new medications. For example, yesterday, Dr. Jim Allison from MD Anderson Hospital was in to see me. He recently got the Nobel Prize for his research in immunology and new treatments for cancer. Over the course of our history, the treatments for cancer have been almost as tough as the cancer itself, whether it is surgery or radiation or chemotherapy. What he has discovered--thanks to the grants by NIH that have helped pay for the research--is a new way to use the body to turn on the cancer itself without the patient receiving additional drugs or radiation or surgery to deal with it. It is just amazing. So I do think we need to continue to encourage that sort of innovation and research. And when companies do pour extensive time and funding into that research and a patent allows them to recover that funding once the drug hits the market, that is a good thing. We are increasingly seeing some companies abuse this system in order to retain exclusivity over a drug for much longer than the patent would ordinarily provide and preventing more affordable genetics or biosimilars from entering the market and competing. From what I have been told by some in the pharmaceutical industry, about 90 percent of the common prescriptions that we take are now generic, and they are pretty inexpensive, relatively speaking. I know that is the case for me, and I believe that is likely true. But for the 10 percent that are still branded, some of those drug prices go through the roof. Then you have an aberration like insulin that has been available for decades, which, through some sort of mystery, an opaque way of pricing, still may cost somebody as much as $1,000 or $1,200 a month for their copay. That doesn't make any sense to me because if we are trying to protect innovation, that argument no longer applies to a drug long ago discovered and essential to the life of diabetics. The chemical formula of the actual drug is not the only thing that can be patented, and that is part of the problem. Manufacturers can get additional patents for follow-on inventions or innovation, which is a new manufacturing method or a new formulation or a new application to a new and different disease. Some of that, I think, is certainly understandable and should be protected. I don't believe that each of these additional patents is inherently wrong, but the reckless abuse of the system and the way they can be structured sometimes is. I will be introducing a bill soon that aims to curb major drug companies' anti-competitive use of patents to prevent generics or biosimilars from entering the market to promote greater competition and lower prices. This legislation would properly define two terms to describe how drug companies are abusing the system and provide the Federal Trade Commission with authority to take action. The first term it would define is ``product hopping,'' which occurs when a company develops a reformulation of a product that is about to lose exclusivity and then pulls the original product off the market, preventing entry of a generic alternative. This may be just [[Page S2717]] by releasing a new formulation that is extended release over time. They can patent that and pull the original drug off the market, and then it prohibits generic competition from entering the market against that original formulation and, thus, maintain their exclusivity well beyond the intended period of time. The only purpose for doing this is not to deliver more effective drugs but to prevent that generic competition. One example is the drug Namenda, which is used by patients with Alzheimer's. Near the end of the exclusivity period, the manufacturer switched from a twice-daily drug to a once-daily drug. That move prevented pharmacists from being able to switch patients to a lower cost generic, allowing the company to continue to profit as a result of their exclusive use of that patent. Secondly, the bill would define ``patent thickets,'' which occur when an innovator seeks multiple overlapping patents or patents with identical claims near when they are about to lose their right to exclusivity. Companies take advantage of our country's robust innovation protection in order to hang onto their monopolies as long as possible. One example is the drug Humira, which is one of the most widely prescribed drugs in the world. It is commonly used to treat arthritis and other autoimmune diseases. AbbVie, the manufacturer of Humira, has 136 patents and 247 patent applications on their drug, which has been available for more than 15 years--136 patents with 247 patent applications. There has to be a reason for that. This type of behavior makes it very difficult for biosimilar drugs to come to market. While the patent on the actual drug formula--the original one--may have expired, there are still in this case hundreds of other patents to sort through and, frequently, to litigate in terms of the validity of those additional patents. The artificial structuring of these multiple patents can delay the entry of generic or biosimilar competition for much longer than anybody ever would have intended-- certainly longer than Congress intended by giving patent protection. By defining product hopping and patent thickets as anti-competitive behavior, we would allow the Federal Trade Commission to bring antitrust suits against the bad actors who deliberately game the system, and we would give them injunctive authority--not money damage authority, but injunctive authority to make the system fairer and operate as Congress intended. The second bill I am going to introduce has to do with Medicare part D--one of the most successful and popular pharmaceutical programs around. Part D sponsors may voluntarily report fraud data to the Centers for Medicare and Medicaid Services, but they are not required to report the number of specific instances of potential fraud, waste, and abuse they identify or the actions they took to address these issues. My bill would implement recommendations for the Department of Health and Human Services Office of the Inspector General to require plan sponsors to report that fraud and improve oversight of this important program. I have learned a lot about prescription drugs during these hearings, a lot about the wonderful lifesaving innovation, the importance of preserving that period of exclusivity for people who invest in the research and develop these new lifesaving drugs, but I have also learned a little bit about some of the abuses, which I have talked about here today, and the need for us to continue to work together to find solutions to provide Texans and all Americans who are struggling to cover the cost of their prescriptions with some relief. By eliminating some of these tactics used by pharmaceutical companies to delay and deter competition, we will increase the availability of generics and give patients greater freedom to choose a drug that works at a price they can afford. By creating more accountability under Medicare part D, we can prevent taxpayers from footing the bill for a broken system. While we are still working to find a solution for the multitude of problems and challenges we face in dealing with the pharmaceutical drug industry, one thing is abundantly clear: A one-size-fits-all, government-run healthcare system is not going to work. Indeed, we need to make targeted, smart reforms that will bring down the cost of prescriptions and not the quality of the entire healthcare system. That is precisely what these two bills will do, and I hope we will be able to advance these pieces of legislation to promote more affordable medications. I yield the floor. The ACTING PRESIDENT pro tempore. The Senator from Washington. Mrs. MURRAY. I ask unanimous consent to speak as in morning business. The ACTING PRESIDENT pro tempore. Without objection, it is so ordered.
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