The 2019 novel coronavirus (coined COVID-19 by the World Health Organization) is the latest in a series of public health emergencies in recent years to challenge product developers in the life sciences community. With every challenge comes an opportunity, in this case to leverage product development plans and technologies to be first-to-market with products useful in remediating some aspect of COVID-19 and its spread. Earlier this year, the U.S. Food and Drug Administration (FDA) announced its commitment to extend all available resources to help expedite the development and availability of medical countermeasures (MCMs) to prevent, treat, or diagnose COVID-19 and, in fact, issued the first emergency use authorization (EUA) shortly thereafter. For life sciences companies exploring potential opportunities to leverage their programs to help treat, detect, or address some aspect of COVID-19, a number of regulatory mechanisms may be available to facilitate and advance product development plans:
- For developers of vaccines, available mechanisms include early engagement opportunities with the FDA as part of pre-EUA submissions and interactions as well as more standard pre-IND processes.
- For developers of therapeutic drugs and biologics, available mechanisms depend upon the stage of product development, and may include pre-EUA submissions, pre-IND submissions, and providing access to investigational drugs and biologics through FDA’s expanded access or Right to Try authorities.
- For developers of devices, including diagnostics, available mechanisms include interactions with FDA through FDA’s Q-Submission Program or through pre-EUA activities. For marketed products, manufacturers should be mindful of introducing claims that extend beyond the scope of those permissible for their products (such as COVID-19 marketing claims).
- For developers of diagnostic tests, FDA makes available an EUA review template for tests that detect the virus. Upon return of the draft template to the FDA in the form of a pre-EUA submission, diagnostic developers should expect a highly interactive review.
Contact Goodwin FDA team members Julie Tibbets or Steven Tjoe for any questions on engaging with FDA on product development plans for COVID-19 MCMs.
Julie TibbetsPartnerChair, Life Sciences Regulatory & Compliance Practice