Which individual has authority to declare a public health emergency that permits the use of unapproved medical products, such as COVID‑19 vaccines?

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Last updated: April 24, 2026 • View editorial policy

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Authority to Declare Public Health Emergency for Unapproved Medical Products

The Secretary of U.S. Health and Human Services (HHS) has the authority to declare a public health emergency that permits the use of unapproved medical products, such as COVID-19 vaccines, through the Emergency Use Authorization (EUA) mechanism.

Legal Framework for Emergency Use Authorization

Under section 564 of the Food, Drug, and Cosmetic Act, the FDA may authorize emergency use of unapproved medical products (drugs, biologics, devices) or unapproved uses of approved products. However, these authorizations require a declaration that circumstances exist to justify the issuance of an EUA, based on a determination made by the Secretary of DoD, DHS, or DHHS 1.

Among the options presented in your question, only the Secretary of HHS holds this statutory authority. The other individuals listed do not have this power:

  • The Director of the FDA implements the EUA once the declaration is made but cannot make the initial emergency declaration
  • The Chief Medical Officer of a health system has no federal emergency declaration authority
  • The Executive Director of the United States Pharmacopeia is a standards-setting organization without governmental emergency powers

Historical Application

This mechanism was successfully deployed during the H1N1 influenza pandemic in 2009 to allow emergency use of certain antiviral drugs in children and personal respiratory-protection devices 1. The same legal pathway was utilized for COVID-19 vaccines and therapeutics 2.

Modified EUA Mechanism

A related but distinct mechanism exists under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which allows the CDC, at the direction of the DHHS Secretary, to authorize emergency use instructions for medical countermeasures 1. This reinforces that the HHS Secretary remains the key decision-maker even for modified pathways.

Key Teaching Points for Residents

When educating new residents about the emergency authorization process:

  • The HHS Secretary's declaration is the prerequisite that triggers FDA's ability to issue EUAs
  • This is a federal-level authority that cannot be exercised by state or local officials or institutional leaders
  • The FDA then evaluates the scientific evidence and makes the determination whether to authorize specific products
  • EUAs are dynamic and can be modified or withdrawn as new safety or efficacy data emerges 2

References

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.