[Congressional Record Volume 165, Number 129 (Tuesday, July 30, 2019)]
[Senate]
[Pages S5157-S5159]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                        Prescription Drug Costs

  Ms. COLLINS. Mr. President, I rise to highlight the bipartisan work 
that is underway in the Senate to help Americans who struggle with the 
high cost of prescription drugs. This problem particularly affects our 
seniors, 90 percent of whom take at least one prescription drug. It is 
critical that we continue to build on the momentum of this important 
pocketbook issue that, I believe, bridges the partisan divide.
  Since 2015, as the chairman of the Senate's Special Committee on 
Aging, I have chaired eight hearings on drug pricing, and we have heard 
so many heartbreaking stories from people who struggle to afford the 
medication that they need.
  I will never forget standing in line at the pharmacy counter in 
Bangor, ME, where I live, when the couple ahead of me received a 
prescription drug and the unwelcomed news that the couple's copay was 
going to be $111. The husband turned to his wife and said: ``Honey, we 
simply cannot afford this.'' They walked away and left that needed 
prescription on the drug store counter. I told the pharmacist I didn't 
mean to overhear but that I just happened to be the next in line. I 
asked him how often this happens, and he gave me the terrible news that 
it happens every single day.
  At a hearing on the skyrocketing price of insulin, we heard 
compelling testimony from Paul Grant, a father of four who lives in New 
Gloucester, ME, who discovered one day, because the 90-day supply of 
insulin for his 13-year-old

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son with type 1 diabetes had tripled to more than $900, that he had to 
resort to paying out-of-pocket for a much lower cost insulin from 
Canada without his receiving any credit toward his insurance 
deductible.
  At our hearing on the cost of treating rheumatoid arthritis, Patty 
Bernard, from Falmouth, ME, testified that her out-of-pocket costs 
soared from $10 to $3,800 per month for Enbrel when she transitioned 
from employer-sponsored insurance to Medicare. She simply could not 
afford this expense and had to switch to a different drug that was not 
self-administered. This switch required her to go to her doctor's 
office once a month for a 2\1/2\-hour infusion, and it did not work 
nearly as well for her.
  At another hearing, we heard from Pam Holt, who was diagnosed with 
multiple melanoma. Ms. Holt is among the 1 million Medicare 
beneficiaries who have annual out-of-pocket prescription drug costs 
that exceed $5,100, which places her in the catastrophic part of 
Medicare Part D. Seniors still pay 5 percent of a drug's cost above 
that threshold, and Ms. Holt had to refinance her home to be able to 
afford her treatment. The price of her medication is staggering at more 
than $250,000 per year, and this is not an optional cost. These are 
costs that are necessary to preserve the lives and well-beings of, in 
particular, our seniors.
  These stories of Americans like Paul, Patty, Pam, and millions of 
others who find it extremely difficult to afford the exorbitant costs 
of the medications they need in order to maintain their health or the 
health of their loved ones have motivated Congress to act on a 
bipartisan-bicameral basis.
  The Senate's Committee on Health, Education, Labor, and Pensions, for 
example, recently approved the Lower Health Care Costs Act, which 
incorporates more than 14 measures to increase drug price competition 
and uses market forces to do so. It includes major provisions from the 
Biologic Patent Transparency Act, which is a bipartisan bill that I 
coauthored with Senator Kaine and is also cosponsored by Senators 
Braun, Hawley, Portman, Shaheen, Stabenow, Paul, and Murkowski. It is 
intended to prevent drug manufacturers from gaming our patent system.
  Patents play a key role in encouraging what can be billions of 
dollars of investment to bring new drugs from the lab table to a 
patient's bedside, but the patent system should not be misused to 
prevent lower priced generic drugs from coming to market once an 
initial patent has expired. Our bill requires an earlier and greater 
disclosure of the web of patents that is held by biologic 
manufacturers, thus making it easier for their competitors, which are 
known as biosimilar companies, to develop more affordable alternatives 
without their being stymied by the filing of last-minute new patents 
that are intended simply to keep competition out of the marketplace.
  It is particularly important that we look at biologics. They have 
been miracle drugs for many Americans, but they are also the most 
expensive category of drugs, accounting for approximately 40 percent of 
total drug costs.
  According to former FDA Commissioner Scott Gottlieb, if all of the 
biosimilars that have been approved by the FDA were successfully 
marketed in the United States in a timely fashion, Americans would have 
saved more than $4.5 billion in 2017. This is an expert calculation 
from the former FDA Commissioner.
  Instead, what happens in too many cases is that the biosimilar 
competitor is available now in Europe or in Canada but not in the 
United States.
  The HELP Committee package also includes the CREATES Act, which 
addresses anti-competitive practices of companies that delay or even 
block access to a sufficient quantity of the brand name drug to conduct 
the bioequivalency test required by the FDA as part of the generic drug 
approval process.
  This addresses one of the problems identified by a major 
investigation that the Aging Committee undertook in 2016, examining the 
explosion in prices of off-patent prescription drugs for which there 
still is no generic equivalent. What we found in some cases is that the 
brand name manufacturer was making it extremely difficult for the 
generic competitor to buy up a sufficient quantity of the drug to do 
these bioequivalency tests that are required as part of the generic 
approval process. That is just plain wrong.
  Due to the provisions in the bill to spur competition, the CBO--the 
Congressional Budget Office--estimates that ``the entry of certain 
generic or biosimilar products could be accelerated by one or two 
years, on average.'' This would make a tremendous difference and would 
reduce consumer as well as Federal and private insurance spending for 
prescription drugs.
  The point I want to make is that this is just allowing the market to 
operate as it should, with competition, transparency, and an end to the 
obstacles and the gaming of the system that prevent lower priced 
pharmaceuticals.
  In addition, the Lower Healthcare Costs Act contains several 
important provisions to shed light on what is currently a complex and 
opaque system. In fact, I cannot think of any other product we buy 
where the price is so opaque and lacking in transparency and in which 
there are such variations in what the cost may be from plan to plan, 
from pharmacy to pharmacy, from manufacturer to manufacturer, and that 
is due to a very complex system that I am going to refer to.
  At the Aging Committee's hearing on the high cost of insulin, the 
American Diabetes Association spoke about the lack of transparency when 
you trace insulin from the manufacturer to the pharmacy counter. Keep 
in mind that insulin was first isolated nearly a century ago, in 1921 
in Canada, and the discoverers provided it for only a dollar because 
they wanted to make it widely available.
  The ADA chart illustrated the complexity and the perverse incentives 
in the supply chain for prescription drugs, and what was clear was that 
rebates are a key problem in driving up the cost of insulin.
  There is a system here that is rife with conflicts of interest. If 
the manufacturer has a high list price, then the pharmacy benefit 
manager, who is negotiating on behalf of the insurer, has an incentive 
to choose that manufacturer's version of insulin rather than another 
manufacturer's because the pharmacy benefit manager is usually 
compensated by getting a percentage of the list price.
  Well, obviously, the manufacturer wants to have its version of 
insulin chosen to be offered by the insurer to its customers. So here 
we have this system, which is rife with conflicts of interest and 
incentives that encourage higher prices because then the middleman is 
going to make more money, and that discount that the middleman--the 
pharmacy benefit manager--is negotiating almost never makes it to the 
pharmacy counter, to the patient who is purchasing the prescription 
drug.
  Sometimes part of that does, indeed, go to the insurer, which can use 
it to lower overall premiums slightly, but we are talking about trying 
to help the person who desperately needs the drug and who is buying it 
at the pharmacy counter.
  As cochairs of the Senate Diabetes Caucus, Senator Jeanne Shaheen and 
I, as well as Senators Cramer and Carper, have introduced legislation 
to address the flaws in the system and to hold PBMs and manufacturers 
accountable.
  We have come up with a bill that would help to reduce the price of 
insulin, and what a benefit that would be for the parents of children 
who have type 1 diabetes, for whom insulin is literally a matter of 
survival. It would also help those older Americans with type II 
diabetes, some of whom are insulin dependent.
  Another significant change included in the Lower Healthcare Costs Act 
requires significantly more disclosure on the costs, the fees, and the 
rebate information associated with PBM contracts. It also includes an 
amendment that was offered by Senator Baldwin, which I supported, to 
require more reporting of drug prices to the Department of Health and 
Human Services and a justification for why prices have increased.
  These provisions all build on a law that I authored last year to 
block pharmacy gag clauses.
  I told the story about the pharmacist who was so frustrated because 
so many people, day after day, were unable to afford the copays or the 
deductibles on

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their needed prescription drugs. Well, I met with a group of community 
pharmacists who told me how the system worked, and they told me that 
there were actually gag clauses in their contracts where they were 
prohibited from sharing with the consumer whether it was cheaper to pay 
out-of-pocket rather than through insurance.
  Well, I am pleased to say, in working with former Senator Claire 
McCaskill and Debbie Stabenow and others, we were able to get gag 
clause prohibitions enacted into law last year. According to one study, 
banning these gag clauses could help Americans save money in nearly one 
out of four prescription transactions. So this is significant 
legislation.
  I talked recently to a pharmacist in Maine who said what a relief it 
was to her to now be able to volunteer to her patients that there may 
be a less expensive way for the patient to purchase needed prescription 
drugs.
  One out of four--nearly one out of four--prescription transactions 
should benefit from the laws that we wrote last year.
  Another bill that I authored in 2017 will promote more competition 
from lower priced but equally effective generic drugs, and it is 
already showing promise. To date, the FDA has granted nearly 200 
application requests under the new, expedited pathway that my law 
provides, and 10 have been approved. That is a much faster pace than in 
the past.
  As cochair of both the Senate Diabetes Caucus and the Congressional 
Task Force on Alzheimer's Disease, I know all too well from listening 
to families in Maine and across the country that the path toward 
finding new discoveries and treatments is often long and difficult and 
that success can be elusive, but we must continue our efforts. When 
pharmaceutical companies start twisting around the incentives that were 
designed to encourage innovation and, instead, distorting them into 
obstacles to competition, Congress simply must act, and that is exactly 
what we are doing.
  I want to applaud the work of the HELP Committee. All of us 
contributed to the bill, and we were ably led by Chairman Lamar 
Alexander and Ranking Member Murray. I also want to recognize the hard 
work of Senator Graham and Senator Feinstein on the Judiciary Committee 
for the bipartisan package of reforms they produced last month.
  Finally, I want to salute the Finance Committee chairman, Chuck 
Grassley, and the ranking member, Ron Wyden, for taking bipartisan 
actions just last week in passing the Prescription Drug Pricing 
Reduction Act. That has many important provisions in it that will 
require more disclosure. It includes a bill that Senator Casey and I 
have authored, as well as many other important provisions, including 
putting a medical inflation cap on certain pharmaceuticals.
  I know how much the Presiding Officer personally cares about this 
issue, and he has contributed greatly to this work as well. My hope is 
that we can build upon this momentum, that we can seize the moment when 
three different committees of the Senate have all been successful in 
reporting to the full Senate three bipartisan bills.
  Our HELP Committee bill was reported by a vote of 20 to 3. That is 
remarkable consensus.
  Let us bring all of these bills to the Senate floor this fall--or 
certainly by the end of the year--so that we can deliver real results 
to the American people by lowering the price of prescription drugs.
  We would then be very proud of listening to our constituents and 
addressing a problem that affects millions of Americans.
  I yield the floor.