After weeks of bipartisan, bicameral negotiations on a legislative package to reauthorize FDA’s user fee programs, Senate Health, Education, Labor & Pensions (HELP) Committee Ranking Member Richard Burr (R-NC) withdrew from further conversations, citing disagreements with policies added during the HELP Committee markup and provisions in the House bill, jeopardizing timely passage of the bill. If the programs are not reauthorized prior to the expiration date of September 30, 2022, FDA will be forced to furlough user-fee supported employees, and operations with respect to products under review or newly submitted will cease.
As part of his withdrawal from the negotiations, on July 14 Senator Burr introduced the Food and Drug Administration (FDA) Simple Reauthorization Act (S. 4535), legislation that would reauthorize the four expiring FDA user fee programs (prescription drug, generic drug, biosimilar and medical device) without any additional FDA policy riders. Sen. Burr’s proposal is an alternative to the other two congressional proposals to reauthorize the FDA user fee agreements:
- The Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, which the HELP Committee reported favorably out of Committee with a bipartisan 13-9 vote last month. In addition to reauthorizing the FDA user fee agreements, FDASLA included several other FDA policies: FDA’s regulation of cosmetics, dietary supplement and lab-developed tests; rare disease drug development; infant formula; and importation of drugs from Canada (for more on the legislation, see the HELP Committee’s section-by-section summary).
- The Food and Drug Amendments of 2022, which passed the House in June with a bipartisan vote of 392-28. Like FDASLA, the House-passed version of the FDA user fee reauthorization proposal contained additional FDA policy riders, including requirements for clinical trial diversity and modifications to FDA’s accelerated approval pathway.
Sen. Burr’s proposal omits all of the FDA policy riders that were included in the House-passed and Senate committee-advanced proposals. All previous reauthorizations of the FDA user fee programs have included additional FDA-related policy riders; in other words, a “clean” reauthorization would be a first since the user fee programs were started in the 1990s. In reaction to Burr’s withdrawal, HELP Committee Chair Patty Murray (D-WA) issued a statement urging Burr to return to the negotiating table, while E&C leaders—Chairman Frank Pallone Jr. (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA)—urged the Senate to pass the House-passed bill to the President’s desk in this statement.
Despite Burr’s departure from the negotiations, all four of the authorizing committee leaders have reiterated their commitment to extending the user fee programs ahead of the statutory sunset on September 30.
NOTE: More detailed information is available through Manatt on Health, Manatt’s premium information service. Manatt on Health provides in-depth insights and analyses focused on the legal, policy and market developments that matter to you, keeping you ahead of the trends shaping our evolving health ecosystem. Available by subscription, Manatt on Health delivers a personalized, user-friendly experience that gives you easy access to Manatt Health’s industry-leading thought leadership. To learn more or schedule a demo, contact Barret Jefferds at email@example.com.