No, FDA Did Not Change Stem Cell Regulations As Advertised
​​[Posted on: Thursday, November 30, 2017]

The week before Thanksgiving, FDA announced “a comprehensive regenerative medicine policy framework” with great fanfare and it appeared that it is finally going to make significant changes to its policies for regulating stem cells. But a review of this framework shows that it is mostly a rehash of old statements and policies. Four new Guidance Documents, a statement by the Commissioner, and new webpage dedicated to regenerative medicine products all add up to mostly reemphasizing old paradigms packaged into new Guidance Documents. The most significant piece of information was FDA’s announcement of the “enforcement discretion” for 36 months for products it knows to be in violation of the current laws. For all practical intents and purposes the so-called enforcement discretion was already in effect by virtue of FDA not taking any substantive action against hundreds of stem cell clinics openly doing business all over the country. There are several reasons this should have been expected. First, FDA does not create laws it only enforces the laws passed by the Congress. The last law that had any provisions for stem cell therapies was the 21st Century Cures Act which only created the Regenerative Medicine Advanced Therapy (RMAT) designation, plus asking FDA to create new guidance documents; which is what FDA did. Second, FDA did not revise 21 CFR 1271, which it does control. Rule-making takes more efforts and is subject to legal and procedural challenges. Guidance documents on the other hand are non-binding documents. FDA took the easier and faster route for itself to create final guidance documents for old documents, and retiring a couple of Guidance documents that became unnecessary due to the new Guidance documents, but overall did not change its message. Using examples, the Guidance documents on minimal manipulation and same surgical procedure, reemphasize FDA’s insistence than anything more very bare bone processing would make a product subject to IND and BLA requirements ignoring the extensive clinical experience with these products for the last decade and hundreds of comments received to the previous guidance documents on these topics. The RMAT guidance and the regenerative device guidance documents also contain confirmation of what should be well known information. The most puzzling provision is the loosely defined 36 month period for companies to become complaint with the current laws. There is no stick at the end of this carrot, so the hundreds of clinics selling various stem cell therapies, which are technically illegal, can keep doing it without any fear for the next 36 months, and thereafter, assuming FDA starts enforcement actions, can decide whether to comply or close shop. FDA did not address many of the comments raised at the public hearings on stem cells in late 2016. It did emphasize that it will closely monitor more risky applications of adult stem cells but did not provide any specifics for how. This framework is neither a new policy nor promise for significant changes.