March 21, 2017 - Issue: Vol. 163, No. 49 — Daily Edition115th Congress (2017 - 2018) - 1st Session
2017 FOOD AND DRUG ADMINISTRATION USER FEE REAUTHORIZATION; Congressional Record Vol. 163, No. 49
(Senate - March 21, 2017)
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[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. ____________________