This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15. More than 150 people attended in-person, including our own Joanne Hawana, with another 500 webinar attendees.
Two of the draft guidances at issue describe what constitutes “homologous use” and “minimal manipulation.” A third document focuses on adipose (fat) tissue and cells obtained from adipose, which are already being used clinically in many different patient populations. Specifically, those drafts elaborated upon the “same surgical procedure” exemption, the meaning of “minimal manipulation” of cells and tissue, and fat-derived stem cells. Additionally, in February 2015, FDA also released a draft guidance document that discusses how HCT/P manufacturers should investigate and report adverse reactions due to communicable diseases experienced by recipients of HCT/Ps.
Currently, HCT/Ps intended for implantation, transplantation, infusion, or transfer into a human recipient have been subject to a distinct set of FDA regulations under the Public Health Service Act (PHSA) and the agency’s authorities to prevent communicable disease transmission for several years. Lower-risk HCT/Ps are regulated solely under Section 361 of the PHSA, and these so-called “361 HCT/Ps” do not require any sort of pre-market approval by FDA before they can be marketed – meaning advertised, sold, and distributed – in the United States, although certain regulatory requirements do apply (e.g., FDA registration, product listing, and compliance with applicable “current Good Tissue Practices”).
Stem cell clinics and other regenerative medicine businesses operating under the lower level of regulatory scrutiny have come under intense fire recently, in the popular media but also from scientific authorities. This seems to have sparked focused attention from FDA that resulted in the issuance of the four draft guidance documents. Counter to this direction is the REGROW Act (S.2689), a bipartisan legislative proposal that seeks to accelerate and create flexibility in the approval process for new regenerative medicine treatments. Certainly this proposed legislation will continue to move through the legislative process, albeit slower now in light of the upcoming November elections. As a result, it may be several months or even up to a year before FDA expands upon or revises these draft guidances and issues them in final form.
Mintz Levin’s Health and FDA lawyers, as well as the health policy experts at ML Strategies, are closely monitoring these HCT/P regulatory and legislative activities. Mintz Levin and ML Strategies have issued a Client Alert on the hearings, which can be found here.