FDA user fee agreement excludes MPL language

• By: AHPA
• On: 09/28/2022 22:19:48
• In: Regulation / Legislation

Congressional proponents of MPL will continue effort to enact MPL requirements in 2022

September 28, 2022

Following months of negotiations, key Congressional committee leaders have agreed on a final bill to reauthorize medical product user fee programs for the U.S. Food and Drug Administration (FDA). Importantly for AHPA members, the FDA user feel deal excludes language that would establish a mandatory product listing (MPL) requirement for dietary supplements and that would substantially increase FDA's regulatory authorities over cosmetics that was previously passed by the Senate Health, Education, Labor, and Pensions (HELP) Committee.

The legislation, which will be attached to a continuing resolution (CR) that broadly funds the federal government through December 16, would reauthorize FDA medical product user fee programs for the next five fiscal years, ensuring funding from industry user fees for nearly half of the agency's budget for fiscal years 2023 through 2027. Both the Senate and House are on track to pass the CR legislation this week. 

The top Democratic and Republican leaders of the key committees with jurisdiction over FDA – the House Energy and Commerce and HELP Committees – ultimately agreed to set aside MPL, cosmetics reform, and a handful of other major health policy initiatives to enact the user fee programs' reauthorizations in time to avert looming layoffs of FDA personnel. However, the committee leaders have expressed their strong interest in continuing to negotiate on the outstanding policy provisions in the coming months with the possibility of inserting several of the reforms in an end-of-the year omnibus spending package that Congress is expected to take up in mid-December.  This stated commitment is a clear sign that the MPL debate is not over in the 117^th Congress.

MPL has been the subject of debate among both lawmakers and the industry with increased attention since June, when the HELP Committee advanced the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348) that included language establishing an MPL requirement for dietary supplements.

AHPA has argued that MPL is unnecessary and would create significant and redundant burdens on industry. Moreover, to date, neither FDA nor other advocates for MPL have clearly articulated the need for this premarket product listing requirement. As the debate over MPL looks to continue, AHPA remains committed to advocating for legislative priorities that would actually benefit consumers and the industry.