Public Health Crises and FDA Scrutiny

Every public health emergency or outbreak brings with it a corresponding urgent need for medical products to address the emerging crisis, and the 2019 novel coronavirus (coined COVID-19 by WHO) is no different. Product developers and marketers are quick to assess in such crises whether their products on the market or in development have utility or can play a role in addressing the crises. Earlier this year, the FDA committed all available resources to rapidly advance and make so-called medical countermeasures (drugs, biologics, and medical devices useful in public health emergencies) available for COVID-19.

With that said, public health crises bring added regulatory enforcement scrutiny to products in the marketplace, which have not followed proper FDA process or authorization to support marketing claims specific to individual crises such as COVID-19. We saw this in January 2020 when FDA issued a Warning Letter that treated hand sanitizer marketing claims specific to addressing the Ebola virus, norovirus, and influenza as claims requiring new drug approval and supportive adequate and well-controlled trials. FDA’s heightened scrutiny extends to the spectrum of products claiming to prevent, mitigate, or treat conditions associated with actual or potential outbreaks. As such, developers of medical countermeasures should carefully plan their regulatory and marketing strategies and seek feedback early. Some marketing considerations for those entering the COVID-19 area include:

  • FDA encourages companies interested in developing therapeutics to request a pre-IND meeting to discuss investigational new drugs for COVID-19. Developers should be mindful of FDA’s prohibition on promoting investigational drugs for yet-unapproved uses, and manufacturers with approved drugs that could have utility in COVID-19 should be mindful of off-label marketing restrictions and exposure.
  • For medical devices, much like the hand sanitizer Warning Letter issued by FDA, device marketers should be mindful of the allowable intended uses for which their devices may be promoted. For example, specific marketing claims of preventing or mitigating the contraction of COVID-19 for over-the-counter devices such as gloves and masks could trigger the need for additional marketing authorization for those products to support specific claims related to COVID-19.
  • On the in vitro diagnostic front, FDA issued the first emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s COVID-19 Real-Time RT-PCR Diagnostic Panel to detect COVID-19 in respiratory specimens. While FDA will help expedite the availability of such tests, it will also scrutinize those being offered without FDA’s authorization. Developers of laboratory developed tests (LDTs), which have historically not been subjected to FDA regulatory oversight, should be aware of FDA’s policy that allows for use of such COVID-19 tests for a reasonable period of time after validation and while EUA requests are being prepared (generally, 15 days).

In summary, the key to marketing success for public health emergencies like COVID-19 is following FDA’s premarket procedures and requirements and appropriately scoping marketing claims based on regulatory classifications, authorizations, and approvals.

  • Julie Tibbets

    Julie K. Tibbets is a Partner at Goodwin Law. Julie is focused on all aspects of FDA-regulated product development, advertising, promotion, and corporate communications. Julie appears on the Washington, D.C. Super Lawyers list of “Rising Stars” and The Best Lawyers in America for FDA law.

  • Steven Tjoe

    Steven Tjoe is a FDA Senior Associate, FDA Counseling Group at Goodwin. Steven advises drug, biotech, medical device, and diagnostic developer clients on a range of FDA regulatory matters, including product development strategies, lifecycle management & competition issues, advertising & promotion issues, and regulatory compliance. Prior to joining Goodwin, Steven served as regulatory counsel at FDA’s Center for Devices and Radiological Health.


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