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As of February 1, 2023, there are 4825 open recommendations that still need to be addressed. 464 of these are priority recommendations, those that we believe warrant priority attention. Learn more about our priority designation on our Recommendations page.

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1 - 20 of 40 Recommendations, including 4 Priority Recommendations
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Food Safety: FDA Oversight of Substances Used in Manufacturing, Packaging, and Transporting Food Could Be Strengthened

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2 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of FDA should request specific legal authority to compel companies to provide specific information that they have about food contact substances already on the market. FDA could do so when it submits its report to the House Appropriations Committee on options to systematically reassess the safety of food additives and obtain information on their use. (Recommendation 1)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Food and Drug Administration The Commissioner of FDA should direct the agency to track the dates of the last pre- and postmarket reviews for all food contact substances in a way that allows FDA to readily identify substances that may warrant postmarket review. (Recommendation 2)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

COVID-19: FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed

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1 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of FDA should develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies. This policy should include the conditions under which FDA would begin and end the use of such discretion. (Recommendation 1)
Open – Partially Addressed

FDA agreed with this recommendation and has taken an action towards implementation. Specifically, FDA announced on September 7, 2022 that it would exercise enforcement discretion for monkeypox testing and limit the period of time an unauthorized test could be used to 30 days to help address the public health emergency. FDA believed this time frame was long enough to address availability and accessibility concerns. FDA also noted that the agency would monitor the situation and may adjust, including shortening or lengthening this time period, as appropriate. We believe this policy for monkeypox

Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference

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2 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The FDA Commissioner should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented, including adding a definition of political interference. (Recommendation 3)
Open

As of October 2022, HHS was updating its departmental scientific integrity policy and its operating divisions, including the FDA, were also updating their individual scientific integrity policies. The updated policies will include specific provisions prohibiting political interference and will establish procedures for reporting and handling allegations of scientific integrity violations, including those involving alleged political interference.

Food and Drug Administration The FDA Commissioner should ensure that FDA employees and contractors performing scientific activities are trained on how to report allegations of political interference in scientific decision-making. (Recommendation 4)
Open

As of October 2022, HHS was updating its departmental scientific integrity policy and its operating divisions were also updating their individual scientific integrity policies. The updated policies will include specific provisions prohibiting political interference and will establish procedures for reporting and handling allegations of scientific integrity violations, including those involving alleged political interference. Following publication of the updated departmental scientific integrity policy, HHS will develop scientific integrity training for employees, contractors, and other persons

FDA Workforce: Agency-Wide Workforce Planning Needed to Ensure Medical Product Staff Meet Current and Future Needs

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2 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of FDA should develop and implement an agency-wide strategic workforce plan to document agency-wide human capital goals and strategies, which should include elements to ensure FDA is able to monitor and evaluate progress toward its human capital goals, such as performance measures to assess the effectiveness of these strategies. (Recommendation 1)
Open

FDA stated in July 2022 that it is working to develop and implement an agency-wide strategic workforce plan to document human capital goals, and anticipates having a baseline version of this plan by the end of fiscal year 2024. GAO will continue to follow the agency's progress on this activity.

Food and Drug Administration The Commissioner of FDA should establish a process to update its agency-wide strategic workforce plan on an ongoing basis. (Recommendation 2)
Open

FDA stated in July 2022 that it is working to develop an integrated strategic human capital plan as well as a process for annually updating the plan. The agency expects to have a baseline version of the plan by the end of fiscal year 2024. GAO will continue to follow the agency's progress on this activity.

Drug Safety: FDA Should Take Additional Steps to Improve Its Foreign Inspection Program

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3 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of FDA should ensure that the agency incorporates leading practices we identified for designing a well-developed and documented pilot program as it finalizes its plans for implementing a pilot program to evaluate the effectiveness and efficiency of unannounced foreign inspections. (Recommendation 1)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Food and Drug Administration The Commissioner of FDA should ensure that the agency incorporates leading practices we identified for designing a well-developed and documented pilot program as it finalizes its plans for implementing a pilot program to evaluate the costs and effects of using different types of translation services during foreign inspections. (Recommendation 2)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Food and Drug Administration The Commissioner of FDA should ensure the agency fully develops tailored strategies—including detailing implementation steps and time frames—focused on recruiting new and developing and retaining current investigators to specialize in conducting foreign drug inspections. (Recommendation 3)
Open

When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Small Business Research Programs: Agencies Should Further Improve Award Timeliness

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1 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of the Food and Drug Administration should evaluate the effectiveness of steps taken to improve SBIR award timeliness and take any necessary additional steps in order to consistently meet SBA award timeliness guidelines. (Recommendation 15)
Open

HHS agreed with this recommendation. According to an April 2022 HHS letter responding to our report as well as additional information provided by the Food and Drug Administration (FDA), FDA stated its intent to assess whether funding the awards based on each of its center's individual budgets could improve FDA's ability to meet SBIR timeliness guidelines. Going forward, we will follow up to obtain data on FDA's award timeliness in subsequent fiscal years to determine if these actions result in the agency being able to consistently meet SBA's award timeliness guidelines. We will provide an

Federal Rulemaking: Selected Agencies Should Fully Describe Public Comment Data and Their Limitations

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1 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of FDA should fully describe available public comment data, including any limitations, to external users of the data. This should include coordination with GSA, as the manager of Regulations.gov, as appropriate. (Recommendation 8)
Open

In March 2022, the Department of Health and Human Services stated that FDA will work with Regulations.gov to improve language on the website relevant to comments. We will continue to monitor FDA's efforts in this area.

Imported Seafood Safety: FDA Should Improve Monitoring of Its Warning Letter Process and Better Assess Its Effectiveness

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2 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of FDA should establish a process to monitor whether the agency is consistently following key procedures and meeting key goals for its imported seafood warning letters, and take corrective action when necessary. This could be done through regularly analyzing data that FDA collects, such as those in CMS and FACTS. (Recommendation 1)
Open

FDA agreed with our recommendation that it establish a process to monitor whether the agency is consistently following key procedures and key goals for its imported seafood warning letters, and take corrective action when necessary. In December 2021, FDA stated that it is developing a warning letter tracking dashboard that will be used to gather and analyze relevant data, such as those in CMS and FACTS, to enable the agency to focus on monitoring follow-up activity timeframes. In addition, FDA is working on updating a Field Management Directive to clarify the agency's goal for official action

Food and Drug Administration The Commissioner of FDA should develop performance goals and measures to assess the effectiveness of its warning letters in ensuring the safety of imported seafood. Such measures could include, but need not be limited to, the percentage of warning letters cases that have been resolved, either through a closeout letter or import alert placement, within 1 year of being issued. (Recommendation 2)
Open

FDA agreed with our recommendation to develop performance goals and measures to assess the effectiveness of its warning letters in ensuring the safety of imported seafood. As of December 2021, FDA stated that it is continuing to evaluate and establish measures that could assist the agency in better assessing the effectiveness of its warning letter strategies to ensure the safety of imported seafood, including the percentage of warning letters cases that have been resolved through a close-out letter, import alert, or other appropriate action, within 1 year of issuance. In addition, FDA is in

COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention

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3 Open Recommendations
1 Priority
Agency Recommendation Status
Food and Drug Administration The Commissioner of the Food and Drug Administration should, as the agency makes changes to its collection of drug manufacturing data, ensure the information obtained is complete and accessible to help it identify and mitigate supply chain vulnerabilities, including by working with manufacturers and other federal agencies (e.g., the Departments of Defense and Veterans Affairs), and, if necessary, seek authority to obtain complete and accessible information. (Recommendation 2)
Open – Partially Addressed

HHS neither agreed nor disagreed with our recommendation. In HHS's response in January 2021, FDA said that it will consider our recommendation as it continues efforts to enhance relevant authorities and close data gaps. Since then, FDA has taken some steps towards implementing our recommendation. For example, the agency issued draft guidance for comment in October 2021 advising manufacturers on reporting the amount of each drug they manufacture for commercial distribution, which was required by the Coronavirus Aid, Relief, and Economic Security Act in 2020. In a September 2022 written response

Food and Drug Administration
Priority Rec.
This is a priority recommendation.
The Commissioner of the Food and Drug Administration should, as inspection plans for future fiscal years are developed, ensure that such plans identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize the goal of risk-driven inspections. (Recommendation 4)
Open – Partially Addressed

FDA concurred with our recommendation and in December 2021 reiterated that it is actively tracking the list of sites that need to be inspected. In June 2021, FDA reported that it was tracking the list of establishments in need of inspection on a quarterly basis and reiterated that the agency continued to use alternative tools to oversee manufacturing quality while inspections are paused. In June 2022, the agency reported that the number of risk-based surveillance inspections was increasing and outlined a plan for largely addressing the backlog within 3 years, assuming global conditions that

Food and Drug Administration The Commissioner of the Food and Drug Administration should fully assess the agency's alternative inspection tools and consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet its drug oversight objectives when inspections are not possible in the future. (Recommendation 5)
Open – Partially Addressed

FDA agreed with our recommendation and has taken steps to document its assessment of existing alternative tools and others to support the agency's regular inspection activities and its oversight efforts when inspections are not possible. For instance, in April 2021, FDA issued an internal memorandum describing how the agency will expand its use of establishment records and other information requested under Section 704 of the Federal Food, Drug, and Cosmetic Act to help plan and prioritize regular inspection activities and to delay or reduce the scope of mandatory surveillance inspections

Federal Property: Formal Policies Could Enhance FDA's Property Management Efforts

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3 Open Recommendations
Agency Recommendation Status
Food and Drug Administration The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., linking decisions to mission-related goals) in the three centers' planning for their personal property needs, consistent with key characteristics integral to asset management leading practices. (Recommendation 1)
Open

FDA concurred with this recommendation. As of March 2021, FDA officials reported that they intend to address this recommendation by having the Office of Laboratory Safety develop an agency-wide inventory control and management system. We will continue to monitor FDA's efforts to address this recommendation.

Food and Drug Administration The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., tracking condition, and maintenance and repair costs) in the three centers' operations and maintenance of personal property, consistent with key characteristics integral to asset management leading practices. (Recommendation 2)
Open

FDA concurred with this recommendation. As of March 2021, FDA officials reported that they intend to address this recommendation by having the Office of Laboratory Safety develop an agency-wide inventory control and management system. We will continue to monitor FDA's efforts to address this recommendation.

Food and Drug Administration The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., measuring and documenting performance) in the three centers' reviews of personal property performance, consistent with key characteristics integral to asset management leading practices. (Recommendation 3)
Open

FDA concurred with this recommendation. As of March 2021, FDA officials reported that they intend to address this recommendation by having the Office of Laboratory Safety develop an agency-wide inventory control and management system. We will continue to monitor FDA's efforts to address this recommendation.

Note: the list of open recommendations for the last report may continue on the next page.

Have a Question about a Recommendation?

For questions about a specific recommendation, contact the person or office listed with the recommendation. For general information about recommendations, contact GAO's Audit Policy and Quality Assurance office at (202) 512-6100 or apqa@gao.gov.