GAO Report Concludes That The FDA Needs To Strengthen Its Efforts To Implement MoCRA

Just over a month after the Food and Drug Administration (FDA) announced its intent to delay enforcement of facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Government Accountability Office (GAO) issued a report, "COSMETIC SAFETY: Better Planning Would Enhance FDA Efforts to Implement New Law," with seven recommendations to strengthen FDA efforts to implement its new cosmetic oversight responsibilities.

1. Develop an implementation plan for MoCRA, including interim steps with specific interim deadlines;
2. Ensure that the Office of the Chief Scientist reports on key milestones for all MoCRA requirements;
3. Develop a process to collect data and evidence to measure the agency's implementation efforts against the MoCRA requirements;
4. Assess the effects of implementing MoCRA on the current and future workforce;
5. Develop a multiyear strategic workforce plan that identifies the needed personnel, skills, and competencies;
6. Develop a plan to strengthen diversity, equity, inclusion, and accessibility (DEIA) when recruiting and hiring staff to implement MoCRA; and
7. Adopt effective recruitment practices.

Although FDA has taken important steps in implementing MoCRA, GAO concludes that the FDA has not fully addressed certain components of implementing the various MoCRA reforms and managing the workforce. This includes, for example, developing a written implementation plan for carrying out MoCRA requirements, reporting on its own progress in implementing MoCRA, strengthening DEIA in its hiring and subsequent implementation of the law, identifying all personnel needed to implement MoCRA, drafting position descriptions for new hires, and creating a recruitment system.

The FDA had an opportunity to comment on GAO report, and generally agreed with GAO's findings and recommendations. Although MoCRA authorized FDA funding levels that increase sharply between 2023 to 2027, no funding has been specifically set aside for MoCRA implementation. FDA has since requested additional funding for 2024 in order to hire new staff to assist in implementing MoCRA, and the agency anticipates requesting funding for additional staff going forward in order to fully implement all of MoCRA's provisions.

Originally Published 12 December 2023

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