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GAO-25-108032 1 (May 7, 2025)

handle is hein.gao/ptyoprcmds0001 and id is 1 raw text is: GA'O U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Comptroller General Washington, DC 20548 of the United States May 7, 2025 The Honorable Robert F. Kennedy, Jr. Secretary U.S. Department of Health and Human Services 200 Independence Ave., SW Washington, D.C. 20201 Priority Open Recommendations: Department of Health and Human Services Dear Secretary Kennedy: Congratulations on your appointment. The purpose of this letter is to call your personal attention to three areas based on GAO's past work and 35 open priority recommendations, which are enclosed.1 Additionally, there are 417 other GAO open recommendations that we will continue to work with your staff to address. We are highlighting the following areas that warrant your timely and focused attention. Specifically: Improve leadership over public health emergency preparedness and response. Deficiencies in the nation's preparedness for public health emergencies have hindered the nation's response to the COVID-19 pandemic, the 2022 mpox outbreak, and a variety of other past emergencies. HHS's leadership and coordination of public health emergencies remains critical to address emerging and concurrent threats that could affect the nation's health and security, such as avian influenza with pandemic potential, and was added to our High-Risk List in 2022. For example, the Strategic National Stockpile is a multibillion-dollar inventory of drugs, vaccines, supplies, and other medical countermeasures that can be used in emergencies. To prepare for public health emergencies, we recommended that HHS develop an approach for regularly managing the risks associated between gaps in the stockpile's inventory levels and recommended quantities. To ensure transparency and effective collaboration, we also recommended that HHS develop and document plans for restructuring the Public Health Emergency Medical Countermeasures Enterprise, the interagency group of experts that advises on prioritizing, developing, procuring, deploying, and effectively using medical supplies and other countermeasures for the Strategic National Stockpile. Ensure effective Food and Drug Administration (FDA) oversight. FDA has a critical role in ensuring the safety, efficacy, and security of the millions of medical products used by Americans each day, as well as the safety of our nation's food supply. This extends to products and food that are manufactured both domestically and internationally. Given that strengthening the food 1GAO considers a recommendation to be a priority if when implemented, it may significantly improve government operations, for example, by realizing large dollar savings; eliminating mismanagement, fraud, and abuse; or making progress toward addressing a high-risk or duplication issue. GAO-25-108032 HHS Priority Recommendations Page 1

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