[Congressional Record Volume 163, Number 132 (Thursday, August 3, 2017)]
[Senate]
[Pages S4789-S4791]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                        FDA Reauthorization Bill

  Mrs. MURRAY. Mr. President, I want to say I am really pleased we are 
moving forward on the FDA Reauthorization Act today. This is really a 
great example about how Congress can actually work together on health 
issues and compromise and solve challenges by putting patients and 
families first.
  As my colleagues well know, these so-called user fee agreements are 
essential to supporting FDA's operation and mission. They allow FDA to 
meet the complex challenges of the 21st century technology and the 
movement toward precision medicine, and they help ensure that FDA 
upholds the gold standard of approval while evaluating new drugs and 
devices efficiently. Put simply, passing the FDA Reauthorization Act is 
absolutely necessary if Congress wants to advance safe, effective

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and innovative medical products for patients and families across the 
country.
  I would add, when we pass this reauthorization today, more than 5,000 
employees at FDA will be able to continue their critical work without 
worry of interruption, employees that worked every day to protect the 
health and families and advance medical innovations to patients.
  So I am really pleased to have worked alongside the chairman of our 
HELP Committee, the Senior Senator from Tennessee, and all of our 
colleagues on and off the committee to bring to the floor these 
finalized agreements.
  They truly reflect years of negotiations between FDA and the 
industry, incorporate input from patient and consumer groups, and 
support some of our most urgent priorities: restructuring the generic 
drug user fees, building up the Biosimilars Program, making sure 
patients' perspectives are considered in drug and device development, 
and advancing many of the policies we passed as part of the 21st 
Century Cures Act.
  In addition to those agreements, the FDA Reauthorization Act includes 
priorities and provisions from Members across the political spectrum, 
so I again want to thank Chairman Alexander and all my colleagues, in 
particular, Senators Casey, Franken, and Warren, on their work to 
improve medical device safety; Senators Hassan and Young on their 
provision to get better information to providers about opioids; 
Senators McCaskill, Franken, and Collins for their commitment to 
improving the generic drug market; and Senators Bennet, Van Hollen, and 
Rubio for their drive to get new medicine for kids with cancer.
  I really want to thank my staff and Chairman Alexander's staff who 
worked so well together over months of hard work to get this done.
  Mr. President, this bill advances several significant bipartisan 
priorities I am proud to support. As many know, the HELP Committee has 
a strong tradition of bipartisan success in these user fee agreements, 
and I am very proud to say we have kept it this way. I think this bill 
not only improves FDA, but it also shows that when we work together 
with a common goal, we can get things done and make progress.
  I thank the chair and my partner, Senator Alexander.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Tennessee.
  Mr. ALEXANDER. Mr. President, I see Senators Isakson and Tester are 
here. I think they want to make remarks before the vote.
  Let me say a few words following up on Senator Murray, and then I 
will place the rest of my comments in the Record.
  This is very important legislation. Last year, we passed the 21st 
Century Cures Act to move these modern medical miracles into medicine 
cabinets and doctors' offices more rapidly. This is funding that pays 
for one-quarter of the Food and Drug Administration, which has a 
critical role in approving the safety and effectiveness of drugs, 
treatments, and devices. As with most things in the Senate that 
actually are important and work well and get a result, a lot of hard 
work has gone into this.
  It started 2 years ago with Republicans and Democrats; Senator Murray 
and I and our staffs working together with the House of Representatives 
at the same time, working with manufacturers, the FDA, many others, 
working out many differences of opinion. So now we are going to get to 
a result within a few minutes. We are probably going to adopt this by 
voice vote almost unanimously. Everyone will say that must have been 
easy. It wasn't that easy, but it is how work gets done in the U.S. 
Senate when we do it well.
  I want to comment on our colleagues and the staff and the House of 
Representatives on what they have done. We will continue to focus our 
attention on the 21st Century Cures Act. A piece of legislation is not 
worth the paper it is printed on unless it is implemented properly, but 
this funding today, done in a timely way, says to the men and women who 
work at the Food and Drug Administration and to their leader, Dr. 
Gottlieb: We value what you do.
  In the 21st Century Cures Act, we gave the Commissioner more 
authority to hire and pay talented people to work at FDA and approve 
these medical miracles that are coming. We are reauthorizing the user 
fees in a timely way so the FDA's work will not be interrupted.
  I thank Senator Murray for the way she worked on this. This is 
typical of our committee when we work well, which we most always do.
  I will make remarks in the Record concerning the staff. They are 
almost too numerous to mention. Senator Murray's staff, my staff, 
Chairman Walden's staff, Ranking Member Pallone's staff, Food and Drug 
Administration staff, Congressional Budget Office legislative counsel, 
and Senator McConnell's staff--they have all been critical to the 
success we are about to have today.
  I would like to thank the staff who have been devoted to 
reauthorizing these important programs. Some of them have been working 
on this bill for over 2 years. I am deeply grateful to them. I have 
deep appreciation for their hard work, their ingenuity, and their skill 
in helping us come to this result. Without their hard work and tireless 
effort, we wouldn't have been able to pass this before the deadline, 
ensuring the FDA can continue its important mission.
  On Senator Murray's exceptional staff, I would like to thank Evan 
Schatz, John Righter, Nick Bath, Andi Fristedt, and Remy Brim.
  On my hard-working and dedicated staff, I would like to thank David 
Cleary, Lindsey Seidman, Allison Martin, Mary-Sumpter Lapinski, Grace 
Stuntz, Margaret Coulter, Curtis Vann, Lowell Schiller, Bobby McMillin, 
Liz Wolgemuth, Margaret Atkinson, Taylor Haulsee, Elizabeth Gibson, and 
Anthony Birch.
  On Chairman Walden's staff, I would like to thank Ray Baum, Paul 
Edattel, and John Stone.
  On Ranking Member Pallone's staff, I would like to thank Jeff 
Carroll, Tiffany Guarascio, and Kimberlee Trzeciak. I would also like 
to thank much of the hard-working staff from the Food and Drug 
Administration who provided great help in getting this bill completed 
and working out the user fee agreements in a timely manner. From 
legislative counsel from the House and Senate, I would like to thank 
Warren Burke, Michelle Vanek, Kim Tamber, and Katie Bonander.
  From the Congressional Budget Office, I would like to thank Darren 
Young, Andrea Noda, Chad Chirico, Holly Harvey, Ellen Werble, and 
Rebecca Yip.
  On Senator McConnell's staff, I would like to thank Scott Raab.
  On Speaker Ryan's staff, I would like to thank Matt Hoffman.
  Finally, I would like to thank all the patients, doctors, 
researchers, innovators, thought leaders, and experts who dedicated 
time and expertise to helping improve the legislation and supporting 
its approval.
  To reiterate, today the Senate will take up and I expect it will pass 
the Food and Drug Administration Reauthorization Act of 2017 to speed 
cures and treatments into patients' medicine cabinets.
  Last year, 94 Senators voted to pass 21st Century Cures and send 
$4.8-billion to spur medical research at the National Institutes of 
Health.
  Leader McConnell called it the ``most important piece of 
legislation'' that year.
  Today's passage of the FDA user fees will help ensure advancements in 
research supported by 21st Century Cures actually make it to patients 
who are waiting.
  The Food and Drug Administration is the agency responsible for making 
sure promising research supported by 21st Century Cures can turn into 
lifesaving treatments and cures.
  This legislation we will vote on today includes four FDA user fee 
agreements--which are set to expire on September 30--and will speed the 
agency's ability to review new prescription drugs, generic drugs, 
biosimilar drugs, and medical devices and bring those treatments and 
cures to patients more quickly.
  This legislation will reauthorize the authority for the FDA to accept 
user fees--paid by manufacturers of drugs and medical devices--that 
account for $8 to $9 billion over 5 years and is over a quarter of all 
FDA funding.
  The reauthorizations are based on recommendations from industry and 
FDA after a thorough public process.

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  FDA posted meeting minutes after every negotiation and held public 
meetings before discussion began and to hear feedback on the draft 
recommendations last fall.
  We began almost 2 years ago working in a bipartisan way to 
reauthorize and update the user fee agreements. We held 15 bipartisan 
Senate health committee briefings, including several with the House 
Energy and Commerce Committee.
  In the Senate HELP Committee, we held two bipartisan hearings on 
these agreements--one in March and one in April of this year.
  We heard from the FDA, witnesses representing the manufacturers of 
drugs and medical devices, and witnesses representing the patients who 
rely on the products they make.
  Throughout this process, we have worked closely with the House. In 
April, the leaders of the Senate and House health committees released a 
discussion draft of bipartisan legislation to reauthorize and update 
the user-fee agreements and which reflected the recommendations sent to 
Congress by the FDA in January.
  In May, the Senate HELP Committee overwhelmingly approved this 
legislation reauthorizing the user fees by a vote of 21 to 2. This also 
included over 20 provisions that were adopted in committee and were 
priorities for HELP members.
  The bill includes provisions from Senators Isakson and Bennet to 
improve the medical device inspection process; Senators Hassan and 
Young to improve communication about abuse-deterrent opioid products; 
Senators Enzi and Franken to encourage medical device development for 
children and make sure FDA has appropriate expertise to review devices 
for children; Senators Roberts, Donnelly, and Burr to allow more 
appropriate classification of accessories used with medical devices; 
Senators Collins, Franken, McCaskill, and Cotton to improve generic 
drug development and help lower prescription drug costs; Senators 
Hatch, Bennet, Burr, and Casey to improve access to clinical trials for 
all patients; and Senators Bennet, Rubio, Van Hollen, and Gardner to 
increase the development of new drugs to treat pediatric cancers and 
other diseases.
  The House passed this user fee legislation on July 12 by voice vote.
  Now it is our turn to pass this bipartisan legislation that is 
integral to helping patients and families who rely on the lifesaving 
medical innovation that FDA is responsible for reviewing.
  The goal of getting this to the President's desk is an important one. 
If we do not pass this legislation before the end of September, FDA 
will begin sending layoff notices to more than 5,000 employees to 
notify them that they may lose their job in 60 days.
  If we do not pass this bill, a FDA reviewer who gets started 
reviewing a cancer drug submitted to the agency in April could be laid 
off before the reviewer is able to finish his or her work.
  A delay in reauthorizing the user fees would not only harm patients 
and families who rely on medical innovation, but it would threaten 
biomedical industry jobs and jeopardize America's global leadership in 
biomedical innovation.
  I am glad the Senate is taking the step of voting on this legislation 
today. I look forward to supporting this important bipartisan bill and 
sending it to the President's desk. I urge my colleagues to support it 
as well.
  The PRESIDING OFFICER. The Senator from Georgia.