Legal Update
Jun 5, 2020
HHS Secretary Amends PREP Act Declaration to Clarify Definition of “Covered Countermeasures”
On June 4, 2020, the Secretary for the US Department of Health and Human Services (HHS) issued a Notice of Amendment (Amendment) to his March 10, 2020 Declaration that had applied the federal immunities of the Public Readiness and Emergency Preparedness Act1 (PREP Act) to the fight against COVID-19. The Amendment clarifies that “Covered Countermeasures” under the Declaration include “qualified pandemic and epidemic products that limit the harm COVID-19 might otherwise cause,” thereby adding a key phrase that was inadvertently omitted from the statutory definition of “Covered Countermeasure” in the Declaration.
As we previously reported, the PREP Act permits the Secretary of HHS to declare that certain “Covered Persons” are immune from liability (i.e., loss sounding in tort or contract, except for claims involving “willful misconduct” as defined in the PREP Act) for taking certain “Covered Countermeasures” that are necessary to respond to a public-health emergency. On March 10, 2020, HHS Secretary Alex Azar issued the Declaration in accordance with the PREP Act, and in doing so extended the Act’s immunities to the battle against COVID-19.
The PREP Act specifies that a covered countermeasure must be a “qualified pandemic or epidemic product”; a “security countermeasure”; a drug, biological product, or device authorized for emergency use in accordance with various sections of the Federal Food, Drug, and Cosmetic Act; or certain approved respiratory protective devices.
The Secretary’s March 10 Declaration, however, inadvertently omitted a phrase in the statutory definition of covered countermeasure, which states that qualified pandemic and epidemic products may also include products that “limit the harm such a pandemic or epidemic might otherwise cause.” In yesterday’s Amendment, the Secretary clarified that HHS intended to include all qualified pandemic and epidemic products defined under the PREP Act as covered countermeasures.
According to the Amendment, “qualified pandemic and epidemic products that limit the harm that COVID-19 might otherwise cause” are those that would not have been manufactured, administered, used, designed, developed, modified, licensed, or procured but for the COVID-19 pandemic, even when the products are manufactured, administered, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure health threats or conditions other than COVID-19. For example, the pandemic has resulted in shortages of certain drugs and devices that the FDA has authorized which may be used for COVID-19 and other health conditions. Those shortages constitute “harm[s] [COVID-19] might otherwise cause.”
According to HHS, replenishing these shortages reduces the strain on the American health care system by mitigating the escalation of adverse health conditions from COVID-19 and non-COVID-19 causes. And mitigating that escalation conserves limited health care resources—from personal protective equipment to healthcare providers—which are essential in the whole-of-Nation response to the COVID-19 pandemic.
The Amendment is currently unpublished but is scheduled to be published in the Federal Register on June 8, 2020.
As we reported, on April 8, 2020, the Office of the Assistant Secretary for Health (OASH) issued guidance authorizing licensed pharmacists to order and administer COVID-19 tests that the Food and Drug Administration (FDA) had authorized.
On April 10, 2020, the Secretary amended the Declaration to extend liability immunity to covered countermeasures authorized under the CARES Act.
And as we reported here, on April 14, 2020, the HHS Office of General Counsel (OGC) issued an advisory opinion specifying that PREP Act immunity may extend beyond actual “qualified persons” and approved “countermeasures”—even though they are technically not covered by the PREP Act—if one could have reasonably believed the persons or countermeasures were covered.
More recently, we advised that HHS’s OGC had issued another advisory opinion which concluded that the PREP Act preempts any state or local law that prohibits a pharmacist from ordering and administering authorized COVID-19 tests.
1. See 42 U.S.C. § 247d-6d.
