[Congressional Record Volume 163, Number 84 (Tuesday, May 16, 2017)]
[Senate]
[Pages S2953-S2954]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                               User Fees

  Mr. ALEXANDER. Mr. President, last year seems like a long time ago, 
but just 5 months ago, 94 Members of this body voted for a bill called 
the 21st Century Cures Act. Senate Majority Leader Mitch McConnell 
called it the most important legislation of the year. The Presiding 
Officer, the Senator from Ohio, had a major role in that legislation, 
especially the part having to do with opioids. This was legislation to 
spur research and development of cures, devices, and treatments for 
some of the most deadly and some of the most stubborn illnesses and 
diseases.
  Dr. Frances Collins, head of the National Institutes of Health--which 
he calls the ``National Institutes of Hope''--last year offered what he 
called bold predictions about major advances that we could expect over 
the next decade with a sustained commitment to medical research. One 
prediction of Dr. Collins is that science will find ways to identify 
Alzheimer's before symptoms appear, as well as how to slow down or even 
prevent the disease. Another is that doctors could use the patient's 
own stem cells to rebuild his or her heart. An artificial pancreas will 
help diabetes patients by tracking blood glucose levels and by creating 
precise doses of insulin. He also predicts a Zika vaccine, a universal 
flu vaccine, and an HIV/AIDS vaccine in the next 10 years. To relieve 
suffering and deal with the epidemic of opioid addiction, Dr. Collins 
predicts new, nonaddictive pain treatments to manage pain.
  The 21st Centuries Cures Act became a law last year and authorized 
4.8 billion new dollars for medical research, on top of the support 
Congress already provides through the annual appropriations process. 
Because of bipartisan support, that was an extra $2 billion last year 
and an extra $2 billion this year. The way we add up money around here, 
over 10 years, that is $20 billion over 10 years last year and another 
$20 billion this year, which includes the $4.8 billion authorized in 
the 21st Century Cures legislation, all for medical research.
  The next step in our efforts to turn Dr. Collins' predictions into a 
reality and to help America's patients benefit from all the research we 
are helping support is to fund the Food and Drug Administration. The 
FDA, as we call it, is the agency responsible for making good on the 
promise of the 21st Centuries Cures Act to actually reach America's 
patients.
  Before September 30 of this year, four different FDA user fee 
agreements need to be reauthorized. They need to be acted on by the 
Senate, by the House, and sent to the President of the United States. 
These user fees are paid by manufacturers of drugs and medical devices 
and account for $8 billion to $9 billion over 5 years and over a 
quarter of all FDA funding.
  Last week, 21 of the 23 members of the Senate HELP Committee voted to 
send to the Senate floor a bill reauthorizing those four user fee 
agreements based on recommendations from industry and from the FDA 
after a thorough and lengthy public process.
  The FDA Reauthorization Act, sponsored by me and by Senator Murray, 
the distinguished Senator from Washington who is the ranking Democrat 
on our Senate HELP Committee, reauthorizes the four user fee agreements 
that expire at the end of September. The four agreements are, No. 1, 
the prescription drug user fee, which accounted for 70 percent of the 
brand drug review budget last year; No. 2, medical device user fee 
amendments, which accounted for 36 percent of the medical device review 
budget in fiscal

[[Page S2954]]

year 2016; the generic drug user fee amendments, which accounted for 
over 75 percent of the generic drug review budget in fiscal year 2016; 
and the biosimilar user fee amendments, which accounted for 29 percent 
of the biosimilar review budget in fiscal year 2016.
  So here is my message to colleagues: The U.S. Senate has the 
opportunity to provide Americans with a prompt, bipartisan 
reauthorization of the Food and Drug Administration user fee agreements 
and, in doing so, take the next crucial step in helping Americans see 
the benefits of the results of our 21st Century Cures Act passed last 
year. If we do not move quickly to pass these agreements in late July, 
the FDA will be forced to send layoff notices to more than 5,000 FDA 
employees to notify them that they may lose their job in 60 days.

  As I said, these reauthorizations are based on recommendations both 
from industry and from the Food and Drug Administration after a 
thorough public process. The FDA posted meeting minutes after every 
negotiation and held public meetings before discussions began and to 
hear feedback on the draft recommendations last fall.
  Patients were also involved in developing commitment letters. We have 
received support from patient groups asking us to authorize the 
agreements expeditiously.
  In Congress, over the last 15 months, the Senate HELP Committee, of 
which I am chairman and Senator Murray is the ranking Democrat, had 15 
bipartisan briefings, some of which were with the Energy and Commerce 
Committee of the House of Representatives, and heard, as well, from the 
FDA and industry about the reauthorization.
  Our HELP Committee held two bipartisan hearings earlier this year on 
the Food and Drug Administration medical device and drug user fees and 
released a discussion draft of our legislation on April 14, which 
provided 2 weeks for public comment.
  I go into all this because I want everyone to see how thoroughly this 
has been discussed and how important it is.
  The committee then worked in a bipartisan way to incorporate comments 
from the public and from members of the committee.
  The manager's amendment--which we approved in the committee last 
week, as I said, by a vote of 21 to 2--includes many priorities that 
are broadly bipartisan. Here are a few examples: legislation from 
Senators Isakson and Bennet to improve the medical device inspection 
process; a provision from Senator Hassan, Democrat, and Senator Young, 
Republican, to improve communication about abuse-deterrent opioid 
products; from Senators Franken, Democrat, and Senator Enzi, 
Republican, a provision to encourage medical device development for 
children and make sure FDA has the appropriate expertise to review 
devices for children; from Senator Baldwin, a provision to make sure 
the full experience of clinical trial participants is studied; from 
Senator Burr and Senator Young, additional reporting to make sure that 
the FDA is meeting their goals and that we can do proper oversight of 
the new agreements. It includes legislation by Senators Casey, Franken, 
and Warren on a pilot project on studying medical devices after 
approval to make sure they work as intended. A provision from Senator 
Cassidy requiring additional guidance for complex generics, like 
EpiPens, so manufacturers know what they have to do to make a generic 
version, was also included. A provision to make new hearing aid 
technology available came from Senators Warren and Isakson, as well as 
a provision from Senators Roberts, Donnelly, and Burr to allow more 
appropriate classification of accessories used with medical devices.
  In the committee markup last week, we unanimously adopted these 
bipartisan amendments, which follow: an amendment from Senator Collins, 
which reflected legislation from Senators Collins, Franken, McCaskill, 
and Cotton on improving generic drug development and helping to lower 
prescription drug costs; an amendment from Senators Hatch, Burr, and 
Casey to improve patient access to clinical trials.
  A delay in reauthorizing these agreements would delay the review of 
drugs and devices submitted after last April 1--more than a month ago. 
If we don't pass these reauthorizations into law on time, which means 
by the end of July, an FDA reviewer who 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. In addition to 
harming patients and harming families who rely on medical innovation, a 
delay in the reauthorization would threaten America's global leadership 
in biomedical innovation.
  After reviewing the recommendations from industry and from the FDA, I 
am convinced these are good agreements for patients. The sooner we pass 
this legislation, the better, to give certainty to patients, doctors, 
FDA reviewers, and companies.
  Mr. President, I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Hoeven). The clerk will call the roll.
  The assistant bill clerk proceeded to call the roll.
  Mr. ALEXANDER. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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