If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a clearly non-compliant fashion?
FDA Commissioner Scott Gottlieb has used very strong language to describe stem cell clinics including the phrase “bad actors”, but so far we haven’t seen much action. Some of these businesses have allegedly seriously harmed patients already and more patients are almost certainly being hurt in various ways on an ongoing fashion.
It may be that the FDA saw e-cig’s as a much riskier situation, particularly with young people involved, and hence dedicated more resources there.
Also, the FDA branch that regulates e-cig’s is different than the branch, called CBER, that regulates biologics and hence stem cells.
Still the agency overall and CBER really should do far more on stem cell clinics and the 40 warning letters issued at once to the e-cig firms indicates that the FDA could go after dozens of what it views as the riskiest of the stem cell clinic firms if it decided it was a priority. Such a step would certainly send a message to the others to get compliant or else there may be real consequences. Some customers of clinics are children, elderly, or other vulnerable populations. Even 5-10 warning letters to the most egregious firms would be a positive step. Of course, stopping at warning letters if the firms in question do not become compliant is a problem too. Sometimes warning letters alone don’t make the major difference that is needed.
My sense including from talking to some of them is that the non-compliant clinics (of course, they don’t necessarily see themselves as non-compliant and there are compliant clinics out there) still just don’t believe there will be real, sizable consequences from the FDA so they keep blowing smoke that their expensive offerings help people and are safe, and they keep on raking in the dough from patients.
The FDA is under some added pressure on stem cell clinics as Sen. Chuck Grassley of Iowa recently sent them a letter in part about the stem cell clinic situation and patient harms in Florida, and the senator gave the agency a deadline of day after tomorrow to respond. We’ll see what the FDA says in response and hopefully we’ll see more action on this problem in the future.