[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.