GOP Sets June Deadline for Completing FDA User Fee Reauthorizations

Regulatory NewsRegulatory News | 06 February 2017 |  By 

Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs.

The setting of the deadline, according to a document obtained by Politico, comes as FDA staff and Congressional staff have recently cancelled meetings to work on the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI), the Medical Device User Fee Act (MDUFA IV), the Generic Drug User Fee Act (GDUFA II) and the Biosimilar User Fee Act (BsUFA II).

Negotiations between FDA and industry and consumer groups on all four reauthorizations concluded before 2017 and all four must be reauthorized prior to the end of September 2017 so FDA can continue to receive the funds it needs to hire the necessary reviewers and perform timely evaluations of new drugs, medical devices, biosimilars and generic drugs, in addition to other requirements laid out in each agreement’s performance goals.

Grace Stuntz, a senior FDA policy adviser at the Senate Health, Education, Labor and Pensions (HELP) Committee recently explained the process for Congress to reauthorize all four of the user fee agreements.

The HELP committee will hold hearings on the recommendations already agreed to and Congress will come to a determination on the funding levels. But if Congress cannot come to an agreement on the user fee programs, furlough notices may be sent out at the end of July, though that process has never been initiated.

When FDA was in discussions to reauthorize PDUFA in 2002, agency officials told the House Energy & Commerce Committee Chairman at the time that if the user fee program was not reauthorized, as many as 2,400 FDA employees (about half of those dedicated to the drug review process) would be furloughed because the agency did not have any carryover PDUFA funds.

The situation this year would be vastly different, however, as FDA has more than $350 million in PDUFA carryover funds now, and the program's size has significantly grown, with more than 4,000 full-time employees.

“A lot of folks would like to have this done through August recess to ensure the trains keep running on time. We did a good job in 2012 where we were done by the end of July,” Stuntz added.

Susan Winckler, chief risk management officer at Leavitt Partners and former FDA chief of staff, also explained the importance of reauthorizing these user fee programs: “By all accounts, 2017 will be a year of transition and adjustment on a number of public policy fronts. However, we have a unique opportunity to reauthorize PDUFA so that the FDA’s timely review of new medicines is enhanced and, above all, that patients directly benefit from the breakthroughs we’re hearing and reading about every day. With industry and regulators working in tandem, the U.S. will maintain its competitive edge and leadership position in global innovation and discovery. Anything less will undermine patients and the health of the nation when it’s clear that Americans expect meaningful actions.” 


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