[Congressional Record Volume 163, Number 49 (Tuesday, March 21, 2017)]
[Senate]
[Pages S1886-S1887]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
2017 FOOD AND DRUG ADMINISTRATION USER FEE REAUTHORIZATION
Mr. ALEXANDER. Mr. President, I ask unanimous consent to have printed
in the Record a copy of my remarks at the Senate Committee on Health,
Education, Labor, and Pensions earlier today.
There being no objection, the material was ordered to be printed in
the Record, as follows:
2017 Food and Drug Administration User Fee Reauthorization
The Senate Committee on Health, Education, Labor and
Pensions will please come to order. We're holding a hearing
today on ``FDA User Fee Agreements: Improving Medical Product
Regulation and Innovation for Patients Part 1.''
Now, Senator Murray and I will each have an opening
statement, then we will introduce our panel of witnesses.
After our witness testimony, senators will have 5 minutes of
questions. The subject of today is the Food and Drug
Administration's medical device and drug user fees. It seems
like a long time ago, but it really wasn't that long ago,
that Congress passed the 21st Century Cures Act. 94 Senators
voted for it, President Obama and Vice President Biden were
strongly in support of it. So were Speaker Ryan and Mitch
McConnell, who called it ``the most important piece of
legislation in the last Congress.
It came through this committee and I thank the members of
the committee, especially for resolving our differences of
opinions and making it possible to reach a consensus. That
bill was about the moving medical products, drugs and devices
more rapidly, in a safe way, through the investment and the
regulatory process into the hands of patients and doctors
offices.
Today, we are talking about really implementing that great
goal, one that shows so much promise for virtually every
American. We're here to talk about how we continue the fund
the Food and Drug Administration, the agency responsible for
making sure the promising research supported by 21st Century
Cures actually reaches patients.
We will hear from witnesses from the agency itself to tell
us how the user fee agreements will improve the agency's
abilities to regulate medical products and promote
innovation. We will hear from patients, device manufacturers,
and brand and generic drug manufacturers in a second hearing,
which is tentatively scheduled for April 4.
I want to thank the witnesses for taking the time to
testify today. We respect the great amount of expertise and
service that you've given for our country. I want to thank
you also for moving so quickly to implement the 21st Century
Cures Act. I noticed specifically that the provision
involving regenerative medicine was published with about a
month after President Obama signed the law.
The first medical product user fee agreement was enacted in
1992. FDA worked with the drug manufacturers to hammer out an
agreement that the agency would collect user fees from drug
manufacturers in exchange for more timely, predictable
reviews. The agreement was a success--it decreased review
times and increased patient access to medicines.
Before September 30 of this year, 4 different user fee
agreements need to be reauthorized: The Prescription drug
user fee is the first one. Now it's common around here to
call it PDUFA, I'm not going to do it. I just can't stand
PDUFA, and MDUFA and GDUFA and the other UFA. So I'm going to
call them if you don't mind, the prescription drug user fee,
which accounted for over 70 percent of the brand drug review
budget in FY2015.
The second one is the Medical device user fee, which
accounted for 35 percent of the medical device review budget
in 2015.
The Generic drug user fee accounted for 70 percent of the
generic drug review budget. Biosimilar user fee accounted for
7 percent of the biosimilar review budget.
Consequences of Failing to Reauthorize
So a lot of the money for the FDA comes from these
agreements with manufacturers of prescription drugs and
devices.
The authority for FDA to collect user fees for medical
product review will expire on September 30 of this year--six
months from now.
Now this is probably the most important part of what I have
to say this morning. If we do not move quickly to reauthorize
these agreements, the FDA will be forced to begin sending
layoff notices to more than 5,000 employees to notify them
that they may lose their jobs in 60 days--that's what they
have to do by law.
A delay in reauthorizing these agreements would delay the
reviews of drugs and devices submitted after April 1, only a
few days away.
For example, if we do not pass these reauthorizations into
law before the current agreements expire, an FDA reviewer who
[[Page S1887]]
gets started reviewing a cancer drug submitted to the agency
in April would be laid off on October 1, before the reviewer
is able to finish his or her work. The sooner we reauthorize
the agreements, the better--to give patients, reviewers, and
companies certainty.
In addition to harming patients and families that rely on
medical innovation, a delay in reauthorizing the user fees
would threaten biomedical industry jobs and America's global
leadership in biomedical innovation.
Process for reauthorization
I am hopeful that this committee, and this Congress, can
work in a bipartisan manner to reauthorize the user fees
before the August recess.
Congress must pass legislation reauthorizing and updating
the fees to support the recommendations contained in what are
called ``commitment letters'' sent to Congress in January.
Now these commitment letters are part of the agreements
between FDA and industry--they establish the agency's
commitments, such as timelines for application review or to
put out guidances in exchange for the fees Congress
authorizes. The letters were transmitted to Congress in
January of this year.
So today's hearing is not the first time members of
Congress or the public is hearing about the recommendations
for reauthorization.
In Congress, while we were working on the 21st Century
Cures and after it was signed into law, the HELP Committee
had 15 bipartisan briefings, some of which were in
conjunction with the Energy and Commerce Committee in the
House of Representatives as well, so we could hear from FDA
and industry about the reauthorization. The first of those
briefings was back in late 2015.
Outside of Congress, the FDA posted meeting minutes after
every negotiation, and held public meetings to hear feedback.
So the content of the commitment letters, and the changes
to the fee authorizations, should not be new, or a surprise,
for any member of this committee.
After the April 4th hearing, I hope to move to mark-up the
legislation in committee as soon as possible.
This is the first time that the user fees have sunset in
the first year of a new administration, so we are starting
hearings a little later this year than we did in 2012.
In order to get this done on time, any additional policies
that Senators may want to attach need to be broadly
bipartisan, related to human medical products, and non-
controversial in order to avoid slowing the package down.
How reauthorization builds on 21st Century Cures
There are many improvements in the commitment letters and
fee structure in these reauthorizations to be excited about.
The prescription drug and medical device reauthorizations
include many provisions that build on the work of 21st
Century Cures, such as: involving patients in drug and
medical device development, dedicated staff to assist in the
development and review of rare disease drugs, improved
timelines, increased guidance for drug and device combination
products, and modernizing the clinical trial process.
There are important structural reforms. Each agreement
contains reporting measures built both by FDA and by
independent third parties, so we can see how the changes are
working. FDA is going to work to implement full time
reporting by 2022, so Congress, patients, and medical product
manufacturers will have a better picture about how resources
are being used at FDA and understand what is needed to do
what we ask.
The biosimilar and generic drug user fee agreement includes
additional staff and resources to approve more biosimilars
and more generic drugs, which provide more competition and
lower drug costs.
These are just a few of the highlights of the
reauthorization and commitment letters. It is a good
agreement for patients, and I look forward to working with
Senator Murray and all the members of the Committee to get it
done expeditiously.
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