In times of epidemics and pandemics, like COVID-19, the federal Public Readiness and Emergency Preparedness (PREP) Act aims to expedite the manufacture, distribution, and use of medical devices and drugs by providing immunity from liability under federal and state law (with some exceptions and limitations).

The PREP Act preempts state law and provides immunity from suit to “covered persons” for “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.” 42 U.S.C. §247d-6d(a)(1). The statutory immunity is neither absolute nor automatic. PREP Act immunity arises only after the Secretary of U.S. Department of Health and Human Services (Secretary) has issued an emergency declaration, as the Secretary has done to address COVID-19 public health emergency (Declaration). See 85 Fed. Reg. 15198 (March 17, 2020). The Declaration, however, limits the scope of immunity provided by the PREP Act.

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