End of a Declared Public Health Emergency — Implications for U.S. Emergency Use Authorizations

This Perspective outlines how the termination of a declared Public Health Emergency (PHE) in the U.S. affects Emergency Use Authorizations (EUAs) for medical products. It explains the legal basis under Sections 319 and 564 of federal law for declaring a PHE and issuing EUAs, and recounts lessons learned during the Covid-19 pandemic, such as the importance of rigorous clinical trials and the flexibility of EUA processes. Despite PHE expiration, Section 564 declarations supporting Covid-19 and mpox EUAs will remain effective, allowing continued access to critical products. The article emphasizes improved regulatory practices, transparency, and expectations for evidence-based approvals in future emergencies.

This Perspective outlines how the termination of a declared Public Health Emergency (PHE) in the U.S. affects Emergency Use Authorizations (EUAs) for medical products. It explains the legal basis under Sections 319 and 564 of federal law for declaring a PHE and issuing EUAs, and recounts lessons learned during the Covid-19 pandemic, such as the importance of rigorous clinical trials and the flexibility of EUA processes. Despite PHE expiration, Section 564 declarations supporting Covid-19 and mpox EUAs will remain effective, allowing continued access to critical products. The article emphasizes improved regulatory practices, transparency, and expectations for evidence-based approvals in future emergencies.