FDA Extends Stem Cell Enforcement Discretion, With a Heavy Heart
[Thursday, July 23, 2020]

This week FDA announced that it has extended its enforcement date for illegal stem cell clinics by six months due to the pandemic. At the same time, FDA released a blog targeted towards patients telling them about the dangers of the illegal stem cell therapies, and a final guidance document reiterating FDA’s policies that almost all stem cell treatments offered in the US require formal clinical trials under IND applications and BLA approval prior to sale to patients. The timing of the extension and the two publications by the FDA is not a coincidence. FDA has long insisted that stem cell therapies offered by numerous physicians in the US for practically all indications are illegal and repeatedly pushed back to any attempts to deregulate such clinics. Stem cell clinics have operated on the fringes of the regulations for more than a decade. The regulations are unclear, and FDA has taken an approach to regulate via guidance documents rather than create rules. There are several scientific and ethical issues on both sides of the argument. While the quality and safety of stem cell therapies are obviously easy to question by the FDA since most clinics offering such therapies do not follow GMP, it cannot be denied that too many people have been treated with such preparations safely. While there is no authoritative and accurate count on how many people have been treated by these stem cell clinics, it is undeniable that the safety issues have be likely been few and isolated to the most egregious practitioners.  There is need for a clear policy and enforcement of the same. FDA has created confusion by on one hand tacitly allowing the stem cell clinics to proliferate and profit, while on the other hand releasing guidance document containing “Nonbinding Recommendations”, and blogs containing opinions and conjectures. If it is illegal and the FDA knows about it, it should be stopped immediately; and if it allowed, under whatever pretext, then FDA cannot expect patients to not explore those options. The FDA clock for enforcement is now at about 12 months. It is not clear exactly what would happen on that day. Will FDA do a nationwide swoop on all stem cell clinics and shut them down, will they send Warning Letters, will somebody be penalized financially or in other ways? While the status quo continues, confusion prevails.