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GAO-20-601R 1 (2020-07-29)

handle is hein.gao/gaobaebla0001 and id is 1 raw text is: GAOU.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 July 29, 2020 The Honorable Lamar Alexander Chairman The Honorable Patty Murray Ranking Member Committee on Health Education Labor and Pensions United States Senate The Honorable Frank Pallone Jr. Chairman The Honorable Greg Walden Republican Leader Committee on Energy & Commerce House of Representatives Public Health Preparedness: HHS Has Taken Some Steps to Implement New Authority to Speed Medical Countermeasure Innovation The Coronavirus Disease 2019 (COVID-19) pandemic as well as past infectious disease outbreaks such as the 2015 Middle East Respiratory Syndrome outbreak raise concerns about our nation's vulnerability and capacity to prevent or mitigate potential health effects from exposure to such threats. Medical countermeasures are drugs, vaccines, and devices to diagnose, treat, prevent, or mitigate potential health effects of exposure to chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious diseases, such as influenza pandemics.1 Our prior work has noted that responding to the ever-changing nature and broad array of CBRN threats often entails developing new technologies and approaches, while the process of researching and developing medical countermeasures is lengthy, complex, and expensive.2 Further, several challenges, including low profitability, intellectual property rights, and the general lack of a commercial market for some medical countermeasures may reduce incentives for pharmaceutical and medical device manufacturers to invest time and money to develop these products instead of others that may be more profitable.3 Several federal departments and agencies have responsibilities for assessing, developing, and procuring medical countermeasures to address CBRN priority threats. The Department of 1We use the term medical countermeasures to also include technologies that might assist the development or use of medical countermeasures. CBRN agents can be natural, accidental, or intentional in origin. 2GAO, National Biodefense Strategy: Additional Efforts Would Enhance Likelihood of Effective Implementation, GAO- 20-273 (Washington, D.C.: Feb. 19, 2020); and GAO, Biological Defense: DOD Has Strengthened Coordination on Medical Countermeasures but Can Improve Its Process for Threat Prioritization, GAO-14-442 (Washington, D.C.: May 15, 2014). 3See GAO, National Preparedness: HHS Is Monitoring the Progress of Its Medical Countermeasure Efforts but Has Not Provided Previously Recommended Spending Estimates, GAO-1 4-90 (Washington, D.C.: Dec. 27, 2013); and GAO, Biological Defense: Additional Information That Congress May Find Useful as It Considers DOD's Advanced Development and Manufacturing Capability, GAO-1 7-701 (Washington, D.C.: July 17, 2017). GAO-20-601R Medical Countermeasure Partner Page 1

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