Grassley Encourages FDA Commissioner to Consider Proposals to Expand Access to Affordable Prescription Drugs
WASHINGTON – Senate
Judiciary Committee Chairman Chuck Grassley is calling on Food and Drug
Administration (FDA) Commissioner Scott Gottlieb to examine legislative
proposals and collaborate with other government agencies to increase consumer
access to affordable prescription medications.
In
a letter to
Gottlieb,
Grassley agreed with the commissioner on the need to address abuses in the
system in order to improve prescription drug costs for consumers. Gottlieb
previously testified that the FDA would work to curtail gaming of FDA
regulations by drug makers, improve the approval process for generic drugs and
eliminate the FDA’s backlog of applications for generics.
Grassley
encouraged Gottlieb to review two bills that he has cosponsored to address
anti-competitive behavior by drug makers and enhance market access to less
costly generic medications. The Preserve Access
to Affordable Generics Act, which Grassley introduced with
Senator Amy Klobuchar (D-Minn.), would expedite consumers’ access to generic
drugs by cracking down on anti-competitive deals where brand-name drug
manufacturers pay generic drug companies to keep cheaper generic alternatives off
the market. Pay-for-delay tactics cost Americans an estimated $3.5 billion
annually. The Creating and Restoring
Equal Access to Equivalent Samples (CREATES) Act, which
Grassley introduced with Senator Patrick Leahy (D-Vt.), would address
abuses in the Risk Evaluation and Mitigation Strategies (REMS) program by
deterring pharmaceutical companies from denying samples to generic companies
for product testing and by giving the FDA more flexibility in making REMS
distribution systems.
Abuses
to REMS programs block $5.4 billion in generic competition each year.
Grassley
called on Gottlieb to consider these two bills as he works to develop a
strategy at the FDA to improve accessibility and affordability of prescription
drugs. Grassley also encouraged Gottlieb to work closely with the Justice
Department and Federal Trade Commission to address anti-competitive behavior in
the pharmaceutical industry. Both agencies play a critical role in holding
companies accountable for abusing regulations and engaging in anti-competitive
practices that harm consumers.
Full
text of the letter follows.
June 19, 2017
Dr.
Scott Gottlieb
Commissioner,
Food and Drug Administration
10903
New Hampshire Avenue
Silver
Spring, MD 20857
Dear
Commissioner Gottlieb,
As
you are aware, I am very concerned with the ability of consumers to access
prescription drugs at an affordable price. So I was encouraged when at your
nomination hearing before the Health, Education, Labor and Pensions Committee
and your hearing before the House Appropriations Committee, you testified that
bringing down the cost of prescription drugs for the American consumer is one
of your top priorities.
In
your testimony, you committed that the Food and Drug Administration (FDA) would
take three steps to lower the cost of prescription drugs. Specifically, you
indicated that the FDA would work to curtail gaming of FDA regulations by drug
companies, seek improvements in the approval process for generic drugs, and
eliminate the backlog of generic drug applications.
You
should know that I agree with many of your ideas to address the accessibility
and cost of prescription drugs. In my opinion, a lack of drug options in the
marketplace, anti-competitive behavior by drug industry participants,
long-standing regulatory backlogs at the FDA, inefficient and ineffective
government bureaucracies, and poor corporate decisions all have contributed to
the current problem.
In
that regard, you have highlighted the Risk Evaluation and Mitigation Strategies
(REMS) program as an example of drug companies gaming the FDA regulatory
process. In congressional testimony, you stated that the FDA was evaluating how
it could “streamline the process the FDA uses to determine whether to waive the
requirement that a generic drug applicant and brand company share a single
system to ensure safe use.” You also testified that the FDA was determining
whether it could “waive this requirement more readily than we have in the past
in situations where sponsors cannot reach agreement after a reasonable period
of time, on the implementation of a shared system.”
I
share your concerns about abuses within the REMS program. In fact, they have
been documented in a recent study, which found that brand drug companies are
abusing the REMs program to block $5.4 billion in generic competition annually.[1]
To
address this problem, I joined several of my Senate colleagues to introduce S.
974, the Creating and Restoring Equal Access to Equivalent Samples (CREATES)
Act. This bill would help the FDA address REMS program abuse, where brand drug
makers restrict generic manufacturer access to samples for product testing and
where brand drug makers refuse to enter into single, shared distribution system
protocols with generic manufacturers. The CREATES Act would deter
pharmaceutical companies from denying samples to generic companies, so they can
conduct testing to produce cheaper generic alternatives. The bill also would
give the FDA more flexibility in making single, shared distribution system
determinations.
I
also have been concerned with another anti-competitive tactic where brand and
generic drug companies enter into agreements where branded companies pay their
generic competitors not to compete as part of a settlement. These deals result
in decelerating the entry of lower cost drugs in the market. In fact, a recent
Federal Trade Commission (FTC) study found that pay-for delay deals cost
Americans $3.5 billion per year. [2] S. 124, the Preserve
Access to Affordable Generics Act, would crack down on these anti-competitive
pay-offs.
I
hope that you will take a close look at these two bills as you formulate your
strategy to address accessibility and the high cost of prescription drugs. Your
support for these bills will help in our shared goal of increasing access and
lowing the price of drugs.
In
your testimony before the House Appropriations Committee, you indicated that
the FDA is working on a drug competition action plan and you expect the FDA to
unveil it soon. I look forward to seeing the details of that plan and working
with you to implement reforms that will improve choice and affordability of
drugs for American patients.
In
addition, I encourage you to work with the FTC and the Department of Justice
(DOJ) to address anti-competitive behavior in the drug industry. They both play
a critical role in holding companies accountable for gaming the system and
engaging in anti-competitive and abusive conduct. The FDA should work alongside
the FTC and DOJ to protect consumers and preserve a competitive marketplace.
Thank
you for your commitment to increasing accessibility and lowering the cost of
drugs for American patients. I encourage you to continue to prioritize this
issue as you begin your tenure as Commissioner of the FDA. I look forward to
working with you and your team on matters pertaining to the FDA.
Sincerely,
Charles
E. Grassley
U.S.
Senator
cc:
Jeff Sessions, Attorney General
Tom
Price, Secretary of Health and Human Services
Maureen
Ohlhausen, Acting Chairman, Federal Trade Commission
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