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In connection with the ongoing COVID-19 pandemic, many Americans have read reports about the Food and Drug Administration’s (“FDA”) use of emergency actions (“Emergency Use Authorizations” or “EUAs”) in connection with bringing COVID-19 in-vitro diagnostic tests and personal protective equipment to market as quickly as possible, without undergoing the full FDA review and approval process. We have prepared the below summary of how the EUA process works for the benefit of our readers.
Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the “Act”) (21 U.S.C. § 360bbb-3), the Secretary of Health & Human Services (“Secretary”) may make a determination that there is a public health emergency that affects, or has a significant potential to affect, national security. Upon the making of such a determination, the Secretary may authorize the introduction into interstate commerce, during the effective period of such a declaration, “a drug, device, or biological product intended for use in an actual or potential emergency.”
Upon the making of such an emergency declaration, the FDA may then issue an EUA for a product if the FDA finds that: (i) the agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition; (ii) based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing (as applied here: in vitro diagnostics), treating, or preventing (as applied here: personal protective equipment) the serious or life-threatening disease or condition; (iii) the known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition; and (iv) there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition.
On February 4, the Secretary determined, pursuant to section 564 of the Act, the significant potential for a public health emergency. On the basis of that determination, the Secretary declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices and in vitro diagnostics for detection and/or diagnosis during the COVID-19 outbreak. On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to the COVID-19 public health emergency.
In connection with the in vitro diagnostic EUAs, the FDA has released an “Accelerated” Template for Laboratories Certified to Perform High-Complexity Testing Under CLIA: EUA Template, as well as a Test Kit Manufacturer: EUA Template. As of March 23, 2020, the FDA has issued at least 15 EUAs in connection with in vitro diagnostics.
On a related note, emergency federal legislation signed earlier this month provides manufacturers of N95 face masks protection against lawsuits when selling certain masks to health-care workers which may otherwise have only been otherwise permitted to be sold for other purposes. Vice President Pence stated that change will enable producers like 3M and Honeywell to sell tens of millions more masks per month to health care providers.
If you have any questions regarding the process for securing approval of COVID19 related therapeutics, testing and preventive materials, please let us know.
Visit our COVID-19 Resource Center often for up-to-date information to help you stay informed on the legal issues related to COVID-19.