The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges presented by the COVID-19 pandemic. However, in its announcement, FDA emphasized that this policy for IND and premarket approval requirements does not apply to products that have been associated with reported safety concerns or have the potential to cause significant safety concerns to patients. This “grace period” for HCT/P sponsors now ends on May 31, 2021.
In November 2017, FDA had issued a new regenerative medicine policy framework consisting of four guidance documents, which we previously discussed here. In this framework, FDA provided for a period of “enforcement discretion” ending in November 2020. This grace period, initially planned to last three years, was meant to give manufacturers time to assess whether they need to seek FDA approval. Citing only coronavirus-related concerns, FDA has now extended this grace period until the end of May, 2021.
In conjunction with today’s announcement, FDA also said it would extend until March 31, 2021, its Tissue Reference Group Rapid Inquiry Program (TRIP), which assists HCT/P stakeholders in obtaining rapid, preliminary, informal, non-binding assessments from FDA regarding how a specific HCT/P is regulated; we previously outlined this program here.
This enforcement discretion policy extension comes after FDA’s U.S. District Court victory against U.S. Stem Cell Clinic, which reaffirmed the agency’s authority to crack down on illegally marketed stem cell therapies. It also follows years of agency actions that demonstrate the government’s growing seriousness and commitment to policing stem cell therapies, which we recently summarized here.
Indeed, despite the extension of the deadline for some HCT/P sponsors, Center for Biologics Evaluation and Research (CBER) Director Peter Marks clarified that FDA’s policy of enforcement discretion only pertains to certain HCT/Ps “that do not raise potential significant safety concerns or reported safety concerns,” adding, “This policy was never intended to provide a cover for bad actors, and [FDA] intend[s] to continue to take action against manufacturers and health care providers who are offering unapproved regenerative medicine products that have the potential to put patients at significant risk.”
In a June 2020 article co-written with FDA Commissioner Stephen Hahn (“Identifying the Risks of Unproven Regenerative Medicine Therapies”), Marks had also recently warned patients that regenerative medicine products that have not been FDA-approved may be unsafe. Hahn and Marks cited an “increasing number of adverse events” following the use of unapproved regenerative medicine therapies as necessary cause for FDA to act to prevent harm. They sternly admonished: “Companies involved in selling products that violate the regulations do so under the erroneous assertion that they are exempt from these FDA provisions.”
Before May of next year, when FDA’s period of enforcement discretion ends and it begins cracking down on HCT/P facilities that do not comply with its regenerative medicine policy framework, it is imperative that facilities that process these products assure they are in compliance with FDA standards.