[Congressional Record (Bound Edition), Volume 163 (2017), Part 4]
[Senate]
[Pages 4503-4504]
[From the U.S. 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.

[[Page 4504]]

       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 
     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.

                          ____________________