PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical Countermeasures Against COVID-19. This expansion allows a broader scope of products to be afforded PREP Act protections, including certain products not directly involved in the treatment of COVID-19. Notably, because the Amendment is stated as a clarification of the original Declaration, this change likely would be construed as retroactive by a court.

The PREP Act[1] provides an affirmative defense to lawsuits with respect to covered drugs, medical devices, and other covered products that are used to respond to a declared emergency, such as the current COVID-19 pandemic. The Act provides immunity from liability under federal and state law for ". . . all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure. . ." consistent with a PREP Act Declaration.[2]

Prior to the Amendment, the Declaration defined “covered countermeasure” in relevant part as “any antiviral, any other drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.” The Amendment is significant as it expands this definition substantially, to include products that “limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might otherwise cause.”[3] HHS explains that the definition is meant to include products used “to diagnose, mitigate, prevent, treat, or cure health threats or conditions other than COVID–19” if the products “would not have been manufactured, administered, used, designed, developed, modified, licensed, or procured but for the COVID–19 pandemic.”[4]

HHS further notes that the expanded definition of "covered countermeasure" includes products that are being manufactured to address drug and device shortages caused by COVID-19. In HHS's analysis, procurement and use of such products will reduce the strain on the health care system as a whole, thereby limiting the harm that the COVID-19 pandemic might otherwise cause. Also, a drug or medical device (e.g., a sedative or a ventilator) that may have multiple uses, including use in the treatment of both COVID-19 and non-COVID-19 health conditions, should qualify under the expanded definition even where the items is used to treat non-COVID-19 conditions.

Notably, the expanded definition set forth in the Amendment supersedes the preamble language indicating that a covered product is one that would not have been manufactured, administered, used, designed, developed, modified, licensed, or procured “but for the COVID–19 pandemic,” and requires only that the drug or device be “used” to limit the harm that might have otherwise been caused by COVID–19, or the transmission of SARS–CoV–2. Therefore, it should not be necessary to prove that a product would not have existed “but for” the pandemic, or to demonstrate that its use was related to the pandemic, as long as the product is used to limit harm associated with COVID-19.

As a final point, it is worth noting that while this amendment expands the universe of products that are considered "covered countermeasures," limits on the contexts in which product is distributed and provided continue to apply in the PREP Act coverage analysis. We analyzed these limitations on distribution in a previous alert.

If you have any questions about how the PREP Act may apply to a product that your company is manufacturing, selling, distributing, or donating to assist in the response to COVID-19, please do not hesitate to contact our team.


[1] 42 USC § 247d-6d.

[2] 42 USC § 247d-6d(a)(1).

[3] 85 FR 34740 (June 8, 2020).

[4] 85  FR at 34741 (emphasis added).


Authored by Allison Pugsley, Joy Sturm, David Horowitz, Peter Spivack, Lauren Colton, and Emily Lyons


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