Gamesmanship Escalates over 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 broad reauthorization package, a significantly different and more extensive measure is on hold in the Senate, as the legislators debate the scope and size of provisions to enhance FDA regulatory authority. The Food and Drug Amendments of 2022 (FDA 2022) approved by the House several weeks ago contains a long list of relatively noncontroversial amendments, but focuses on reauthorizing the fees before then (see HR7667).

The Senate version of the user fee legislation, the FDA Safety and Landmark Advancements (FDASLA) Act, has drawn opposition from Republicans for including major amendments that overhaul the agency’s regulation of diagnostics, dietary supplements, and cosmetics. Although the full package was approved by the Senate Health, Education, Labor and Pensions (HELP) committee several weeks ago, it drew fire from Sen. Richard Burr (R–NC), ranking Republican on the panel. Burr strongly objected to including such significant policy changes in the user fee bill and recently countered by backing a highly streamlined version that primarily would renew the fee programs. Burr stated in proposing his FDA Simple Reauthorization Act that the Committee’s proposal would undermine drug development for critical therapies by expanding the agency’s authority and fails to hold FDA accountable. His “clean reauthorization represents the clearest path forward,” he concluded.

House leaders responded by urging the Senate to pass its already-approved user fee bill, or something close to it, to move the process forward. However, observers now are pessimistic that Congress will approve a new user fee package before August, thus requiring the agency to send out furlough notices.

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.