FDA’s Options Against ‘Violative’ Stem Cell Clinics

Attorney Mark Schwartz (Hyman, Phelps & McNamara) says FDA has a number of enforcement options it can turn to after its enforcement discretion for stem cell facilities and certain other HCT/P manufacturers ends 11/2020. Writing in his firm’s FDA Law Blog, Schwartz says FDA indicated in a news release that it is “discouraged” about how few manufacturers have wanted to interact with the agency during the enforcement discretion period.

He says that given the number of facilities in operation and the low number contacting the agency, “it is highly unlikely that most of these clinics will voluntarily cease operations by the end of the period. In that eventuality, what are FDA’s options?”

So far, Schwartz writes, FDA’s policy with regard to stem cell facilities has largely been wait-and-see, with some untitled letters and Warning Letters but rarely any additional enforcement actions.

He identifies three potential enforcement options for the end of 2020: 

•          continue to only litigate the types of cases already being litigated, meaning primarily facilities where there are allegations of serious or life-threatening adverse events;
• ·         also litigate instances of facilities administering stem cells via routes of administration associated with higher risk, even when there are no allegations of serious or life-threatening adverse events, and/or instances of facilities administering stem cells that are intended for non-homologous uses that are intended for prevention or treatment of serious and/or life-threatening diseases and conditions; or
•          litigate even more broadly any alleged violations of the four regulatory criteria.

Schwartz says the third option would be so bold as to be unmanageable given the number of facilities currently in existence, and it also doesn’t allow for any reasonable means of prioritizing which cases to bring. He says the first option is likely to be unsatisfactory for FDA given that it has been exercising this option for the past several years and the stem cell industry still continues to flourish.

“That leaves option #2,” he concludes. “The question is how many lawsuits will FDA need to bring under this option for the hundreds of facilities … to reconsider marketing their stem cell products, and does the agency have the resources and the intestinal fortitude to bring all those cases. Time will tell.”