On Friday, March 13, 2020 Covington & Burling hosted a Briefing Call titled “COVID-19: Evolving Considerations for the Life Sciences Industry” spearheaded by the firm’s Food, Drug and Device industry practice. Contributors cited were Grant Castle, Denise Esposito, Nigel Howard, Mike Imbroscio, Jen Plitsch, and Paula Katz.
The discussion was wide-ranging and made some important points. We cover these below.
FDA’s New Authority
The March 4 State of Emergency declaration made by Alex Azar, Secretary of Health and Human Services gave FDA broad new authority. Some of the powers of interest allow FDA to grant Emergency Use Authorizations (EUAs) which allow new products/indications etc. onto the market without the usual applications normally applicable to drugs, devices, diagnostics, and biologics. FDA will work with manufacturers to evaluate evidence of safety and effectiveness at hand; companies may be allowed to proceed to market using, for example, anecdotal evidence or incomplete clinical trials. The decision will depend on a risk assessment and documentation of evidence at hand, but FDA is amenable to working closely with firms and waiving the usual requirements.
Manufacturers with emergency product clearances are eligible for immunity from lawsuits resulting from products cleared under the declaration.
Money is available to enter into contract development with agencies within HHS and manufacturers should examine the contracts carefully to determine how using government funding will affect intellectual property, especially patents. Many normal contract restrictions, e.g. sole source, small business set-aside, can be lifted.
FDA is also being flexible with GxP considerations as long as an alternate plan is documented; e.g., quality review done by teleworking rather than in-person supervision. Deviations in GCP are expected in clinical trials (recruitment, in-person assessments) as long as protocol changes are documented and the risk is assessed; trial sponsors should work with their IRB and FDA.
Reporting and Shortages
Reporting requirements remain in place, especially in the case of shortages and FDA expects to hear about expected and actual shortages. For supply chains, they will relax rules specifying outsourcing goods and services as long as risk assessments are in order.
Inspections and Desk Audits
Foreign inspections, except for “mission-critical” inspections, have been postponed. A slowdown in domestic inspections is also expected; FDA is considering the use of desk audits, relying on specified documentation from the manufacturer.
Covington & Burling experts invite questions from health industry manufacturers. Contact information is available at www.cov.com.
NOTE: Shortly after the Covington & Burling briefing, FDA announced that Roche had become the first commercial test developer to achieve EUA status for a diagnostic test for COVID-19 in an application granted within 24 hours of agency receipt. In another update Friday, FDA Center for Devices and Radiological Health Director Jeffrey Shuren said over 60 developers have worked with the agency on potential EUA submissions, and more than 30 labs have said they plan to begin testing under the recent FDA coronavirus policy allowing use of pre-EUA lab-developed tests.