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Regulatory Focus™ > News Articles > 2021 > 4 > Strategic hiring and retention needs dominate PDUFA VII subgroup discussions

Strategic hiring and retention needs dominate PDUFA VII subgroup discussions

Posted 23 April 2021 | By Joanne S. Eglovitch 

Strategic hiring and retention needs dominate PDUFA VII subgroup discussions

Finance-oriented discussions between industry and the US Food and Drug Administration focused on strategic hiring and retention, according to the meeting summaries provided by the agency in the ongoing Prescription Drug User Fee Act (PDUFA) reauthorization negotiations of user fees from FY 2023 to 2027.
The summaries were from the finance subgroup, one of eight different groups comprised of industry and agency representatives that have been meeting over the past year to thrash out priorities for the next five-year program.
The meeting summaries from January and February, which were only recently released, show the need to attract and retain talent as a priority; the topic was discussed in at least four of the six meetings. The PDUFA finance committee met six times since January.
The FDA said in its five-year plan for PDUFA for 2018 to 2022 that hiring and retaining “top scientific talent” is a top priority. Another is providing additional compensation to current and new staff under a new pay authority provided by the 21st Century Cures Act.
At its last meeting on 3 February, finance subgroup participants “discussed the proposed approach to support the strategic hiring and retention needs of the PDUFA program.” The summary further states that “FDA will provide proposed draft statutory and commitment letter language for industry to review.”
Also discussed were “approaches to phasing in hiring at the start of PDUFA VII.” At this meeting, the FDA “answered industry questions clarifying the preparations to increase hires and the potential impact on fees.”
The 27 January meeting summary states that “FDA and industry continued discussions of approaches to support the strategic hiring and retention needs of the PDUFA program. FDA and industry discussed options for how this could work with the existing annual revenue setting process and reached tentative agreement on the approach. FDA agreed to provide draft commitment language for the next meeting.”
The 6 January and 13 January meetings also discussed hiring and retention.
Another repeat topic was clarifying the documentation required for manufacturers to financially qualify for orphan drug designation. The topic was raised at two meetings.
The summary from the 14 January meeting states that “industry agreed to FDA’s proposed change to the statutory language regarding the timing and nature of the financial information needed to document financial qualification for the orphan drug exemption. This includes changing the time frame to the prior calendar year for submitting a certification supported by tax returns or, when necessary, other appropriate financial information.”
In August 2017, the FDA Reauthorization Act of 2017 was enacted, which renewed PDUFA for the sixth time. The current legislative authority for PDUFA VI expires in September 2022. At that time, new legislation will be required for the FDA to continue collecting prescription drug user fee in future fiscal years.
Feb. 3 minutes
 Jan 28 minutes
Jan. 27 minutes
Jan. 13 minutes
Jan. 14 minutes
Jan. 6 minutes


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