
Gamesmanship Escalates over FDA User Fee Legislation
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
As the timeframe narrows for reauthorizing FDA user fees before the Congressional August recess, legislators are devising strategies for advancing the legislation, while FDA leaders are preparing for the worst. Without reauthorization of new fees for drugs under the Prescription Drug User Fee Act (PDUFA), generic drugs under the Generic Drug User Fee Act (GDUFA), biosimilars under the Biosimilar User Fee Act (BsUFA), and medical devices under the Medical Device User Fee Amendments (MDUFA) by early August 2022, the agency is required to notify staff of possible layoffs and closures several weeks before the current fee authorization expires on Oct. 1, 2022. Although user fee reauthorization bills usually include a range of measures that make significant changes in FDA programs and operations, the stalemate in Capitol Hill now has prompted a leading Senator to propose a slimmed-down, fee-only bill to meet the renewal deadline.
If Congress fails to act before the end of the current fiscal year, FDA would lose its authority to collect fees from manufacturers, along with requirements for meeting certain timeframes and for utilizing agreed-on policies for assessing and approving new drugs and medical products. Just as damaging to the agency, FDA is required to send out pink slip notices to staff who are supported by fee revenues, warning of potential layoffs.
While the full House has approved a
The Senate version of the user fee legislation, the
House leaders
Such a development could not come at a worse time, according to FDA commissioner Robert Califf, who sees enormous implications in delay for funding user fees. FDA will try to review products as quickly as possible, but won’t meet set timelines and commitments, Califf said at a meeting sponsored by the Alliance for a Stronger FDA last week.
He and other FDA officials already are struggling to attract qualified experts to the agency and had anticipated that the added funds and provisions in the new user fee programs would enhance that process. Without approval of new appropriations bills for 2023 and the new user fees, “we’d have to lay people off,” Califf said. And FDA already is “in a period of the ‘Great Resignation’”, he noted, as burnt-out staffers are leaving the agency, worn out from contending with long work hours and extreme pressure to evaluate and approve new vaccines, medicines, and diagnostics under tight timeframes to combat the COVID-19 pandemic. Hiring new staffers will be impossible, Califf noted, as he questioned who would want to work for an organization where jobs may not even exist in the near future.
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