FDA Suspends Routine Domestic Drug and Device Inspections Due to COVID-19

For-cause inspections will proceed if deemed “mission critical.” The US Food and Drug Administration (FDA) had previously announced on March 10 that routine foreign inspections were suspended. FDA suggests that it may attempt to conduct domestic inspections through other means.

FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve. Domestic for-cause inspection assignments will be evaluated and will proceed if deemed “mission-critical.”

FDA indicated that it was evaluating alternative methods to conduct inspections (e.g., record reviews) during this interim period that would not jeopardize public safety and protect both company employees and FDA staff. The agency did not discuss how (or whether) it would address preapproval inspections required for certain medical device, drug, and biologic submissions (e.g., marketing applications and supplements), though these inspections will likely be delayed. It is possible FDA could exercise discretion on a case-by-case basis to approve products based exclusively on a desk review.

As noted in our prior LawFlashes on medical devices and drugs and biotechnology products, FDA issued a press release on March 10 stating its intent to postpone routine foreign inspections until April. FDA also stated inspections outside the United States deemed mission-critical (e.g., for-cause inspections) will still be considered on a case-by-case basis.

In the March 10 and March 18 communications, FDA explains that it will continue to rely on its other tools to oversee the safety and quality of FDA-regulated products. These include

• screening products imported into the United States through FDA’s risk-based import screening tool (PREDICT);
• evaluating product performance through required manufacturer product reporting of events; and
• relying on manufacturers to comply with the current Good Manufacturing Practice (cGMP) regulations.

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Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Dennis Gucciardo
Michele Buenafe
Jacqueline Berman