HHS Issues New Guidance on PREP Act Immunity When Prescribing, Administering, or Dispensing Drugs and Devices for COVID-19

On April 14, 2020, the Department of Health and Human Services (HHS) issued an Advisory Opinion,¹ which provided additional clarification on immunity provided under the Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to Coronavirus Disease 2019 (COVID-19).²  This article provides an overview of the PREP Act immunity for health professionals and provider entities prescribing, administering, or dispensing drugs, biologics, vaccines, or devices to treat, diagnose, cure, prevent, or mitigate COVID-19.

HHS’s new guidance clarified it is not applying strict liability approach for qualifying as a “covered person” under the PREP Act.  The PREP Act defines “covered persons” to include licensed health professionals or other individuals authorized to prescribe, administer, or dispense the covered countermeasure (defined below).  The term “person” includes individuals in addition to partnerships, corporations, associations, entities, or public or private corporations.  Most notably, HHS clarified that a person who otherwise meets the requirements for immunity will not lose that immunity, even if they are later determined to not be a covered person, so long as the person reasonably could have believed, under the current, emergent circumstances, that they were a covered person.³

HHS similarly noted that Congress did not intend to impose a strict liability standard on determining whether a product is a “covered countermeasure.”⁴ The PREP Act Declaration defines “covered countermeasures” as any antiviral, other drug, biologic, diagnostic, other device, or vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, any device used in the administration of any such product, and all components and constituent materials of any such product.⁵  All such covered countermeasures must also be “qualified pandemic or epidemic products” or “security countermeasures,” authorized for investigational or emergency use by the U.S. Food and Drug Administration or respiratory protective devices approved by National Institute for Occupational Safety and Health, as applicable.

The Advisory Opinion provided that a person will not lose immunity if that person reasonably could have believed that the product was a covered countermeasure, even if the product is later determined to not be a covered countermeasure.⁶ HHS clarified its position with the following example: If a covered person purchases counterfeit COVID-19 tests or respirators, that person would still be immune against a claim arising out of the use of the counterfeit products if the person had taken reasonable steps, under the current, emergent circumstances, to substantiate the authenticity of the counterfeit products.⁷  

Because there are large numbers of approved, licensed, or cleared COVID-19 products, and these products are changing frequently, there is no one definitive list of covered countermeasures for COVID-19.  However, HHS provided a list of certain products including diagnostic tests and personal protective equipment, which have been granted emergency use authorization.⁸

In addition, HHS shed light on the broad nature of PREP Act immunity.  Covered persons are typically immune from liability for all claims for loss, except for willful misconduct that proximately caused death or serious injury.  However, even in cases of death or serious injury, certain acts or omissions may still be immune under the PREP Act.  For example, if a qualified person follows the Secretary of HHS’s directions regarding the administration or use of a covered countermeasure and provides the Secretary, or a State or local health authority, with information regarding the serious physical injury or death within 7 days, the person will be deemed to have not engaged in “willful misconduct” as a matter of law.⁹

Notwithstanding this guidance, it is important to note that PREP Act immunity is not absolute.  Notably, practitioners or providers are not insulated from civil, criminal, or administrative federal enforcement actions or claims under federal law for equitable relief.  Also, as a general matter, PREP Act immunity is limited to claims for personal injury or damage to property.  It is thus, critical that providers document the reasonable precautions they have taken when prescribing, administering, or dispensing drugs, biologics, vaccines, or devices to treat, diagnose, cure, prevent, or mitigate COVID-19.

For more information on the PREP Act, contact  Charmaine A. Mech.

[1] HHS, Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act, 1-9 (Apr. 14, 2020), https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf (hereinafter “Advisory Opinion”).

[2] 85 FR 15198 (Mar. 17, 2020); see also 85 FR 21012 (Apr. 15, 2020).

[3] HHS, Advisory Opinion at 6.

[4] Id. at 4.

[5] 85 FR 15202 (Mar. 17, 2020); 85 FR 21014 (Apr. 15, 2020).

[6] HHS, Advisory Opinion at 4-5

[7] Id.

[8] HHS, Advisory Opinion at footnote 2.

[9] Id. at 7.  See also 42 U.S.C. § 247d-6d(c)(4).