[Congressional Record Volume 169, Number 22 (Thursday, February 2, 2023)]
[Senate]
[Pages S218-S219]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                        Prescription Drug Costs

  Mr. CORNYN. Mr. President, last weekend, the New York Times ran a 
story entitled ``How a Drug Company Made $114 Billion by Gaming the 
U.S. Patent System.'' This is an infuriating account of how a 
pharmaceutical company maintained a monopoly on a popular drug and the 
impact it has had on patients and taxpayers.
  The company is AbbVie, and the drug is Humira, one of the most widely 
prescribed drugs in the world. It is an anti-inflammatory medication 
that is commonly used to treat arthritis and other conditions.
  Despite the fact that Humira has been available for two decades, its 
first competitor didn't hit the market until earlier this week. That 
wasn't due to a lack of interest by other companies or an inability to 
produce the biosimilar that could earn Food and Drug Administration 
approval. It was because AbbVie used a maze of overlapping patents and 
an aggressive litigation strategy to stave off any competition.
  Unsurprisingly, this led to big earnings for the company--$114 
billion in revenue since 2016--and it has come at a high cost to 
patients who rely on this drug to maintain their health. The list price 
for Humira is more than $80,000 per year, per patient. That is higher 
than the median household income in Texas.
  So depending on the patient's insurance, that price could be lowered 
significantly for the consumer or the patient themselves. A woman in 
Kentucky said her employer's health insurance plan kept her payments at 
around $60 a year. But, of course, we know that, if the insurance 
company is paying retail or some negotiated price, ultimately that 
price is going to be passed along in terms of higher insurance premiums 
for the consumer.
  So there is a lot of bait and switch going on here. Once she retired 
and switched to Medicare, the cost skyrocketed to $8,000 a year. So her 
private insurance kept her payments to $60 a year, but when she changed 
to Medicare, it went to $8,000 a year. This is, again, part of the 
shell game in healthcare and in pharmaceuticals.
  I can't imagine anyone living on a fixed income who could afford such 
an expensive drug. The good news, at least for this specific drug, is 
that, at long last, Humira's monopoly has come to an end. Earlier this 
week, the first biosimilar came to market, and more are expected later 
this year.
  Humira is one of the most egregious examples of patent abuse, but it 
is far from the only one. Other pharmaceutical companies are engaging 
in this practice every day, and there is nothing to prevent others from 
using this same playbook. I hope that will change soon.
  Earlier this week, Senator Blumenthal, the Senator from Connecticut, 
and I reintroduced a bill called the Affordable Prescriptions for 
Patients Act to put an end to this anticompetitive practice that keeps 
drug prices artificially high.
  There are two practices in particular that this bill will address. 
One is called patent thicketing--patent thicketing--which involves 
building layers upon layers of patents to prevent competitors from ever 
hitting the market. That is what AbbVie did with Humira. The company 
has--or has had, until just now, with its monopoly ending--as many as 
134 active patents for a single drug--134 patents.
  Now, I am a firm believer in the patent system. I believe we ought to 
protect investments made in cutting-edge and lifesaving drugs, and we 
ought to reward those who invent these lifesaving drugs with an 
exclusive right to sell it for a period of time. That is what the 
patent law does, and it incentivizes more and more people--more and 
more scientists and medical researchers--to come up with new lifesaving 
drugs.
  But getting 134 patents on the same drug should outrage all of us. 
Like I said, this drug has been available for 20 years. AbbVie has 
spent years and exorbitant amounts of money, but, apparently, they 
still profited. They spent a lot of money fighting competition off in 
court, all to maintain control of the market on this drug.
  Like I said, patents and exclusivity periods are not inherently bad. 
Discovering new cures is a time-, labor-, and money-intensive process, 
and we don't want to discourage that. Before a company spends years and 
hundreds of millions--or even billions--of dollars researching a new 
cure, conducting clinical trials, and undergoing the regulatory review, 
it needs to know that it can recoup its investment and maybe--just 
maybe--make a profit.
  And many of the new drugs that are invented and tried do not succeed. 
So success is certainly not guaranteed. That is why the United States 
offers robust protections for intellectual property through the patent 
system.

  The patent system gives innovators the confidence they need to invest 
their time and resources into research and development. Once that new 
innovative drug hits the market, the manufacturer can enjoy a limited 
time period as the sole supplier before generic versions become 
available or other competitors.
  Patents are the key behind the incredible medical innovation that 
occurs here in the United States, and we need to find the right balance 
between stopping the bad actors who will game the system and, at the 
same time, encouraging the development of future cures.
  I believe the bipartisan bill that Senator Blumenthal and I are 
reintroducing strikes that balance. It places a reasonable limit on the 
number of patents that a manufacturer can contest. That will deter 
gamesmanship while preserving the incentives necessary for the patent 
system and for innovation.
  The other anticompetitive behavior this bill will address is 
something called 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.
  This is done not because the new formula is more effective but 
because it prevents generic competitors. One example is the drug 
Namenda, which is used by patients with Alzheimer's, a terrible 
disease. Near the end of the exclusivity period, the manufacturer 
switched from a twice-daily drug to a once-daily drug. It didn't change 
the

[[Page S219]]

basic molecules. It just changed the prescribed dosage and taking, 
instead of twice a day, to once a day.
  That move prevented pharmacists from being able to switch patients to 
a lower cost generic, even though it is just as effective, so the 
company could continue to profit. The Affordable Prescriptions for 
Patients Act puts an end to this practice by expressly prohibiting 
manufacturers from engaging in product hopping. It also facilitates 
market entry for generics and biosimilars, which lead to more options 
and lower prices for patients.
  These reforms are, obviously, desperately needed. Patients in Texas 
and across the country are experiencing sticker shock at the pharmacy 
counter like never before. Many have tried to ration their critical 
medications, for example, in order to make them last longer. Some have 
been priced out of their medications entirely.
  There is a clear need for Congress to step in and address the blatant 
abuse of the patent system, and I am optimistic that we will be able to 
do something important about it.
  The Judiciary Committee will hold a markup next Thursday to consider 
this legislation and other bipartisan proposals to address sky-high 
drug prices. Last Congress, the Affordable Prescriptions for Patients 
Act passed the Judiciary Committee with unanimous bipartisan support, 
and I hope we will see the same level of support this go-round.
  Over the last few years, we have held many hearings and advanced many 
drug pricing bills to the Senate floor, but, unfortunately, progress 
seems to often end there. We haven't had much success in getting those 
bills through the House and signed into law. I think I can speak on 
behalf of colleagues on both sides of the aisle and say I hope this 
year is different.
  I have heard from many Texans who are frustrated by the lack of lower 
priced generic drugs. Given the impact of inflation on family budgets, 
that strain has only grown greater over the last few years. So there is 
a bipartisan desire to stop the anticompetitive behaviors that I have 
described here today that are costing patients and taxpayers a fortune, 
and I hope we can make progress this Congress and finally put a stop to 
some of the gamesmanship.
  Senator Blumenthal and I are committed to moving our bipartisan bill 
across the finish line, and we are eager to have others of our 
colleagues join us by cosponsoring this bill. But more important than 
that, it is important we actually get it across the finish line, get it 
through the House, and get it to the President's desk. So I hope this 
bill will continue to receive broad bipartisan support, and I am happy 
to work with anyone who has ideas to help us get there.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Ms. STABENOW. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.