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FDA User Fee Reauthorization Legislation Continues to Simmer in Congress: What’s at Stake and What It Means for September | Akin Gump Strauss Hauer & Feld LLP

UFA Reauthorization Legislation Update

As noted in Akin Gump’s previous analysis, the current five-year authorization of Food and Drug Administration (FDA) user fee programs for branded/reference drugs and biologics, medical devices , generic drugs and biosimilars is due to expire on September 30. 2022. Unlike previous reauthorization cycles in which Congress passed the user fee reauthorization package earlier this summer, Congress did not pass the reauthorization package until the August recess . This alert provides an update on the status of congressional deliberations, policy reforms under consideration, and next steps.

During this year, Congress considered details of the FDA user fee reauthorization legislation, including user fee program recommendations that the Secretary of Health and Human Services (HHS ) shared with Congress earlier this year, along with other potential FDA recommendations. -related reforms. On June 8, the House of Representatives passed its FDA User Fee Reauthorization Bill (HR 7667, the 2022 Food and Drug Amendments) by a bipartisan vote of 392 to 28. Less a week later, on June 14, the Senate Health, Education, Labor and Pensions (HELP) Committee approved S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act ), by a bipartisan vote of 13 to 9. These key steps in the legislative process set the stage for the “four corners” – the chairmen and senior members of the Senate HELP Committee and the Energy and Chamber Commerce – to negotiate and deliver a final package by the September 30 deadline, avoiding any disruption to these critical programs.

Background

The FDA User Fee Reauthorization Legislation is an attractive vehicle for policy riders, as the legislation is seen as “must pass” given that user fees fund a significant portion of review programs FDA premarket. The basis of the House and Senate bills is the reauthorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA), the Generic Drug User Fee Amendments of 2017 (GDUFA), the Biosimilar User Fees 2017 (BsUFA) and Medical Device User Fees Changes 2017 (MDUFA). As is the case in every reauthorization cycle, the House Energy and Commerce Committee and the Senate HELP Committee also included a series of significant FDA-related legislative changes. This reauthorization cycle, the differences between current House and Senate reauthorization bills are greater than in previous cycles. In particular, the Senate HELP Committee package included significant reforms regarding the regulation of in vitro clinical testing (the VALID Act), as well as cosmetics and dietary supplements – the so-called Senate “super riders”.

At this time, the House and Senate have yet to announce a consensus package. The last time a reauthorization of FDA user fees was not passed by Congress before an August recess was in 2007. Since the House’s passage of HR 7667 and the Senate Aid Committee action on S. 4348, last month Senator Burr also introduced the Food and Drug Administration Simple Reauthorization Act (S. 4535) – an alternative reauthorization bill that would simply reauthorize user fee programs based on the Secretary’s recommendations and without substantive policy amendments. The following table highlights notable provisions included in each reauthorization bill.

And after? Timeline and outlook

The current five-year user fee reauthorization is set to expire on September 30. To date, the FDA has refrained from issuing “reduction in effect” notices to employees in positions funded by these user fee programs. FDA Commissioner Robert Califf said the PDUFA program has enough carryover funds to cover five weeks of the next fiscal year and that the agency is seeking “reasonable assurance” from Congress that it will act on the legislation soon. reauthorization.

Whether or not the House and Senate announce a consensus package in the coming weeks, there will be mounting pressure for Congress to pass some sort of reauthorization legislation in September to reauthorize programs and minimize potential disruptions to activities funded by agency user fees. If there is no “reasonable assurance” of passage, at some point in September the FDA will likely proceed with preparations for a possible reduction in these user fee programs, even if reauthorization remains ultimately likely. These preparations will only heighten the focus on a reauthorization exercise in September. In the event that Congress moves a smaller reauthorization package, it could set the stage for some political runners who don’t move in September to be revisited in a lame duck Congress. For example, the Senate HELP Committee included FDA-related reforms in its bipartisan PREVENT Pandemics Act and it is unclear whether Congress could bundle some of these reforms with other FDA laws, whether with reauthorization of expiring user fee programs or other legislative vehicle. .

While there is great uncertainty as to the timing and scope of this reauthorization, and in particular as to whether it will contain the “super runners” regarding the regulation of cosmetics, dietary supplements and in vitro clinical testing, it no doubt there remains a high degree of interest on and off the Hill regarding these provisions and a strong desire to reauthorize these programs in a timely manner. Once again, FDA issues are about to take center stage when Congress returns in September.