In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the COVID-19 pandemic. Included in a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use,” this extension will give manufacturers additional time to determine whether they need to submit an investigational new drug (IND) or marketing application and to prepare and submit to FDA any required IND or marketing application before the enforcement discretion period expires on May 31, 2021. This extension should come as a welcome reprieve to manufacturers of affected products, many of which delayed seeking FDA approval of their products following release of the enforcement discretion policy guidance in November 2017.

Originally announced in November 2017 as part of a suite of guidance documents outlining FDA’s regenerative medicine policy framework, FDA’s enforcement discretion policy was intended to provide manufacturers and health care providers a period of three years to come into compliance with the pre-market review requirements for those Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) that do not meet the criteria for regulation solely under section 361 of the Public Health Service (PHS) Act and 21 CFR Part 1271.  The enforcement discretion period was originally set to expire on November 30, 2020.

The substance of FDA’s enforcement discretion policy has not changed in the final guidance. FDA still intends to exercise enforcement discretion with respect to the IND and the premarket approval requirements for HCT/Ps that do not meet one or more of the criteria for regulation solely as an HCT/P including those relating to minimal manipulation and homologous use, provided that use of the HCT/P does not raise significant safety concerns, such as those based on the route and site of administration and the intended use.

The guidance reiterated that FDA has increased its oversight of cellular and tissue products that do not comply with current standards and that patients should ensure that any regenerative medicine products they are using are FDA-approved or covered by an IND.

Spreeha Choudhury, a 2020 Summer Associate (not admitted to the practice of law) in the firm’s Washington, DC, office, contributed significantly to the preparation of this post.