Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist human cell, tissue, and cellular and tissue product (HCT/P) manufacturers, as well as stakeholders that market HCT/Ps, to “obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated.” Under the program, FDA will respond within three business days to each inquiry that contains sufficient detail for evaluation, “resources permitting,” informing the requestor whether an HCT/P appears to be (a) appropriately regulated under section 361 of the Public Health Service Act (PHSA), (b) appropriately regulated under section 351 of the PHS Act and/or Federal Food, Drug, and Cosmetic Act (FDCA), or (c) not an HCT/P.
In November 2017, FDA had issued a regenerative medicine policy framework consisting of four guidance documents (previously discussed here), and announced a period of enforcement discretion ending in November 2020. This three-year grace period was meant to give manufacturers time to assess whether they need to seek FDA approval. Now, at the midway point between those two dates, Dr. Sharpless expressed concern that those offering HCT/Ps, including stem cell treatments, have been coming into compliance with these requirements “slower than expected.” As a result, Dr. Sharpless said, FDA will be streamlining regulatory responses in this space, in order “to help stakeholders that may have questions about how their products are regulated.”
This comes on the heels of 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 three years of agency actions that demonstrate the government’s growing seriousness and commitment to policing stem cell therapies, which we recently summarized here.
The TRIP program supplements FDA’s existing mechanisms for evaluating the 361 status of marketed and contemplated HCT/Ps, which include (1) standard requests for recommendations from the Tissue Reference Group, (2) formal Requests for Designations (RFDs) from the Office of Combination Products, which result in binding, final agency determinations, and (3) requests for pre-RFDs, which result in preliminary, non-binding feedback from the Office of Combination Products on the classification of an HCT/P. A company or organization contemplating these options should consider the risks and benefits carefully, including whether they may give rise to disclosure obligations, may create competitive advantages or disadvantages, and may provide insights into how to ensure continued ability to offer HCT/Ps after November 2020.
The TRIP will run until December 31, 2019. For any questions relating to FDA’s regenerative medicine policy framework, including engaging the agency through TRIP on your product’s classification and Biologic License Applications/Investigational New Drug requirements, please contact any of the authors of this article or the Hogan Lovells lawyer with whom you regularly work.