Senate health Committee Chairman Lamar Alexander said Tuesday Congress owes patients and their families a prompt, bipartisan reauthorization of the Food and Drug Administration medical devices and drug user fees agreements, which are set to expire on Sept. 30.
“We ended last year passing the 21st Century Cures Act, which Leader McConnell called ‘the most important piece of legislation’ that year,” Alexander said at Tuesday’s hearing. “94 Senators voted for the legislation, which also had the support of President Obama and Vice President Biden. Today, we are here to talk about how we continue funding the FDA, the agency responsible for making sure the promising research supported by 21st Century Cures actually reaches patients.”
The four different user fees that are the subject of Tuesday’s hearing and must be updated and reauthorized by Congress are the prescription drug user fee act (PDUFA), the medical device user fee amendments (MDUFA), the generic drug user fee amendments (GDUFA), and the biosimilar user fee act (BsUFA).
“If we do not move quickly to reauthorize these agreements, in late July, the FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days,” Senator Alexander said. “A delay in reauthorizing these agreements would delay the reviews of drugs and devices submitted after April 1. 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 Oct. 1, before the reviewer is able to finish his or her work.”
He continued, “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.”
Alexander’s full, prepared remarks are below and video is available here:
The subject of today’s hearing is the Food and Drug Administration medical device and drug user fees.
We ended last year passing the 21st Century Cures Act, which Leader McConnell called “the most important piece of legislation” that year.
94 Senators voted for the legislation, which also had the support of President Obama and Vice President Biden.
Today, we are here to talk about how we continue funding the FDA, the agency responsible for making sure the promising research supported by 21st Century Cures actually reaches patients.
We will hear from witnesses from the FDA to tell us how the user fee agreements will improve the agency’s ability to regulate medical products and promote innovation.
We will hear from patients, device manufacturers, and brand and generic drug manufacturers in a second hearing tentatively scheduled for April 4.
I want to thank the witnesses for taking the time to testify today and also thank you for moving so quickly to begin implementing the 21st Century Cures Act, specifically the regenerative advanced therapy designation.
The first medical product user fee agreement was enacted in 1992. FDA worked with 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, 4 different user fee agreements need to be reauthorized:
1. Prescription drug user fee act (PDUFA), which accounted for over 70 percent of the brand drug review budget in FY2015;
2. Medical device user fee amendments (MDUFA), which accounted for 35 percent of the medical device review budget in FY2015.
3. Generic drug user fee amendments (GDUFA), which accounted for over 70 percent of the generic drug review budget.
4. Biosimilar user fee act (BsUFA), which accounted for 7 percent of the biosimilar review budget.
The authority for FDA to collect user fees for medical product review will expire on September 30 of this year – six months from now.
If we do not move quickly to reauthorize these agreements, in late July, the FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days.
A delay in reauthorizing these agreements would delay the reviews of drugs and devices submitted after April 1.
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.
I am hopeful that this committee, and this Congress, can work in a bipartisan manner to reauthorize the user fees before August recess.
Congress must pass legislation reauthorizing and updating the user fees to support the recommendations contained in what are called “commitment letters” sent to Congress in January.
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 on certain topics, in exchange for the fees Congress authorizes. The letters were transmitted to Congress in January of this year.
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 21st Century Cures and after it was signed into law, the HELP Committee had 15 bipartisan briefings, some of which were with the Energy and Commerce Committee as well, to hear from FDA and industry about the reauthorization. The first of those briefings was back in late 2015.
Outside of Congress, FDA posted meeting minutes after every negotiation, and held public meetings before discussions began and to hear feedback on the draft recommendations last fall.
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 later this year than we did in 2012.
In order to get this done on time, any additional policies Senators may want to attach need to be broadly bipartisan, related to human medical products, and non-controversial to avoid slowing this package down.
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:
o Involving patients in the drug and medical device development process to make sure innovative new drugs and devices address what patients think are most important.
o Dedicated staff to assist in the development and review of rare disease drugs.
o Improved timelines and increased guidance for drug and device combination products, such as heart stents with drugs.
o Modernizing the clinical trial process so we can start to shorten the 8-10 years it takes to develop new drugs and get them to medicine cabinets.
There are also important structural reforms that will help managers at FDA make sure that the feedback FDA gives to people developing new drugs and devices is consistent. Similarly situated companies should not be given different advice about what studies are necessary.
Each agreement contains reporting measures, both by FDA and by independent third parties, so we can evaluate 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 generic drugs, which provide more competition and lower drug costs.
These are just a few highlights of the reauthorization and commitment letters. It is a good agreement for patients, and I look forward to working with Senator Murray and members of the HELP Committee to get it done expeditiously.