Public Health Emergency to Expire

According to the transition notice published in February 2023, the Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency for COVID-19, declared under Section 319 of the Public Health Service Act, to expire at the end of the day on May 11, 2023. The FDA’s Emergency Use Authorizations (EUAs) for COVID-19 products, including tests, vaccines, and treatments, will not be affected (see guidance). Certain FDA COVID-19-related guidance documents for industry will end or be temporarily extended (see FDA Guidance Documents Related to Coronavirus Disease 2019 (COVID-19). In addition, Public Readiness and Emergency Preparedness (PREP) Act liability protections may be impacted.