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Open Recommendations (38 total)

Drug Safety: FDA Should Implement Strategies to Retain Its Inspection Workforce

GAO-25-106775
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should ensure that FDA develops and implements action plans that address attrition caused by issues with investigator travel, workload, and work-life balance. In doing so, ORA, CDER, and other relevant stakeholders should collaborate to identify strategies that balance current inspectional needs against the need to retain an experienced workforce and identify any necessary actions, resources, or new authorities. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Clinical Research: FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection Workforce

GAO-24-106383
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should evaluate its recruitment and retention efforts for BIMO investigators—such as increased pay, student loan repayment, and other financial incentives—to determine their effectiveness and incorporate results of this evaluation as appropriate to help ensure the agency is using the most appropriate tools to maintain its BIMO investigator workforce. (Recommendation 1)
Open
FDA concurred with our recommendation. In September 2024, FDA indicated in written comments that it was gathering data to evaluate the effectiveness of these recruitment and retention efforts. It wrote that evaluating these data-such as the effect of increased pay and student loan repayments-will enable FDA to target the most effective methods for recruiting and retaining BIMO investigators, but that some of these efforts may take time to evaluate. We will continue to monitor FDA's efforts. This recommendation will remain open until FDA provides documentation about how it will incorporate the results of these evaluations into its recruitment and retention efforts.

Federal Regulation: Selected Emerging Technologies Highlight the Need for Legislative Analysis and Enhanced Coordination

GAO-24-106122
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should identify and document the specific changes to its statutory authorities that would enable FDA to take the actions it determines best to oversee AI/ML-enabled medical devices, and then communicate these potential legislative changes to Congress. (Recommendation 1)
Open – Partially Addressed
FDA agreed with our recommendation. In a July 2024 letter, FDA said that it is engaged in the procedures outlined in the Office of Management and Budget's (OMB) Circular No. A-19 for the coordination and clearance by OMB of agency recommendations on proposed, pending, and enrolled legislation. FDA said that it is unable to estimate when this process will be completed. FDA has also identified and communicated to Congress about several authorities that it believes will be necessary to maintain safety and effectiveness standards while not stifling the pace of innovation. For example, FDA described its strategic vision for more effective regulation of AI/ML-enabled devices to Congress and other stakeholders, highlighting the need for additional statutory authority in its May 22, 2024 testimony before the House Energy and Commerce Subcommittee on Health. We will continue to track FDA's progress and provide updated information when available.

Food Safety: FDA Should Finalize Plans to Implement Its Rule to Help Trace Source of Outbreaks

GAO-24-106563
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1 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The FDA Commissioner should direct the Center for Food Safety and Applied Nutrition to finalize and document an implementation plan to help the agency achieve its regulatory goal of compliance with the food traceability rule by January 20, 2026. Such a plan should include FDA's resource needs, strategies for facilitating compliance with the rule, and detailed plans for communicating with and educating regulated entities, nonfederal regulatory partners, and FDA regulatory staff about the rule's requirements. (Recommendation 1)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.

Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law

GAO-24-105542
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4 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist develops a multiyear strategic workforce plan that identifies the needed personnel and capacity, including skills and competencies, to implement all MoCRA requirements. (Recommendation 5)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist develops a plan to strengthen DEIA when recruiting and hiring additional staff to implement MoCRA. Such a plan could be incorporated into a multiyear strategic workforce plan for MoCRA implementation. (Recommendation 6)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist assesses the effects of implementing all MoCRA provisions on the current and future workforce. (Recommendation 4)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist reports on key milestones for all MoCRA requirements. Processes for such reporting could be incorporated into an implementation plan for MoCRA. (Recommendation 2)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.

Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law

GAO-24-105542
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2 Open Recommendations
Agency Affected Recommendation Status
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist develops processes to collect needed data and evidence to measure the agency's MoCRA implementation efforts against requirements identified in the new law. Such processes for data and evidence collection could be incorporated into FDA's implementation plan for MoCRA. (Recommendation 3)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
Food and Drug Administration The FDA Commissioner should ensure that the Office of the Chief Scientist develops an implementation plan for MoCRA—including a timeline with interim steps and interim deadlines—for completing all MoCRA requirements within the statutorily prescribed deadlines. (Recommendation 1)
Open
FDA agreed with this recommendation. We will update the status of the recommendation when we receive information from the agency regarding their actions to implement it.
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