FDA Alert

FDA Taking Overdue Steps to Accelerate COVID-19 Diagnostic Testing

March 21, 2020

In response to the COVID-19 pandemic, and in light of the persistent shortage of diagnostic tests for the SARS-CoV-2 virus, the U.S. Food and Drug Administration (FDA) provided recent but overdue guidance on the use of its Emergency Use Authorization (EUA) authority and has taken additional steps to liberalize its oversight of clinical laboratory diagnostic testing tor the SARS-CoV-2 virus.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 360bbb-3), the FDA may authorize “emergency use” of unapproved products or unapproved uses of approved products to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.  An Emergency Use Authorization (EUA) is possible only upon an emergency declaration or a threat justifying emergency authorized use, such as “heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents” or, in the present case, “a public health emergency… that involves a biological, chemical, radiological, or nuclear agent or agents.”

 Even without an emergency use declaration, FDA is authorized to approve expanded access of investigational drugs. FDA approves expanded access for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. For example, FDA has granted over 250 patients expanded access to Gilead Science’s investigational antiviral drug remdesivir.

Today, FDA also issued a new guidance implementing a policy to expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. Read the entire alert here.

Foley Hoag has formed a firm-wide, multi-disciplinary task force dedicated to client matters related to the novel coronavirus (COVID-19). For more guidance on your COVID-19 issues, visit our Resource Page or contact your Foley Hoag attorney.