Why GAO did this study. Remdesivir is an antiviral drug patented and manufactured by Gilead. Along with its parent compound, remdesivir was originally developed to treat viral hepatitis and a viral respiratory infection. Remdesivir was later studied for antiviral activity against multiple viruses. It was the first drug approved by the FDA to treat COVID-19. Public interest organizations have raised questions about the extent of federal support for the development of remdesivir. Federal support can benefit the public by creating new inventions and may result in certain intellectual property rights, including patents, for the federal government. Multiple federal agencies support biomedical research and development, which can directly or indirectly contribute to the development of new drugs like remdesivir. These federal agencies include NIH—the largest public funder of biomedical research in the world—as well as CDC and DOD. GAO was asked to review federal contributions to the development of remdesivir. This report examines: (1) scientific and funding contributions provided by CDC, DOD, and NIH for the development of remdesivir, and (2) agencies’ patent rights related to those contributions. GAO reviewed relevant laws and regulations; reviewed documentation from CDC, DOD, and NIH; and interviewed officials and scientists from the agencies and two universities. We also obtained information from and interviewed representatives of Gilead. CDC, DOD, NIH, and Gilead provided technical comments, which we incorporated as appropriate.
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