[Congressional Record Volume 165, Number 76 (Wednesday, May 8, 2019)]
[Senate]
[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.