FDA Starts to Turn the Screws on the Stem Cell Clinics
​[Thursday, January 10, 2019 ]

Just a few days before Christmas, FDA sent letters to several stem cell clinics asking them to respond to FDA’s finding that they are offering stem cell products that are not compliant with the law. The letters are gentle reminder that FDA is not going to ignore these clinics for long and that it intends to follow-through on its promise of strict enforcement by Nov 2020. Stem cell clinics offering most autologous stem cell therapies for practically all ailments have been in the crosshairs of the FDA for a few years. Most of these clinics claim to follow the ambiguous Human Cell and Cellular and Tissue therapies (HCT/P) regulations under 21 CFR 1271. The scope of the regulation is subject to interpretation where FDA has taken a more conservative interpretation that strictly limits the use of such therapies while the physicians and patients have taken the opposite stance. FDA tried to regulate such therapies via guidance documents. Of the most the 10 guidance documents released by FDA over the last decade providing FDA’s interpretation of the regulations, most provide FDA’s assertion of the limited scope of the 1271 regulations. In many ways, FDA has tried to expand the regulation via guidance. FDA even organized public hearings on the topic and met strong public opposition to FDA’s interpretation of the laws. Even several state regulators have not supported FDA’s interpretation. Still FDA has persisted with cherry-picked facts and, in the opinion of many, the weakly supported claim of safety issues. But FDA is the final decider of the law and it has taken it upon itself to rein in the stem cell clinics forcing everyone to either follow the IND and BLA route for most offerings or close shop. The letter sent to clinics is a step to scare clinics to comply with FDA’s wishes. And comply they will unless someone decides to challenge FDA in the courts. And that would be an interesting debate. Fingers crossed.