I didn’t know until recently that the FDA has a blacklist, which is called the “FDA Debarment List”. You can check it out here.
Should one or more particularly egregious unproven stem cell clinic operators should be on the list given their risk-taking with patients in the name of profit? There aren’t any on there now that I could see. It’s a fairly short list.
Why would FDA have such a thing more broadly? The blacklist is for those who have seriously broken regulations and the law.
The FDA describes it technically this way:
“The following is a public list of firms or persons debarred pursuant to sections 306(a), (b)(1) and (b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a), (b)(1), and (b)(2)) as published in the FEDERAL REGISTER (FR).”
What exactly triggers someone getting temporarily or even permanently banned from the drug arena completely?
Cornell Law School has some more of the legal provisions in a past piece. It seems like some kind of criminal conviction is a key trigger for consideration of debarment by the FDA, which apparently does not always have to be a felony conviction depending on the context and could even be a misdemeanor.
FDALaw Blog has an example of a debarment case from 6 years ago here.
FDA can also “disqualify” an investigator, which is described on another page. I’m not sure how the disqualification proceedings interface (or not) with the debarment “blacklist”.
It wouldn’t shock me to see a clinic firm or two pop up on the list in the next year or so, but who knows?
Also, the current debarment list has no firms and only lists people by name so I guess maybe a different question is in order: could a few stem cell clinic owners/leaders get on the FDA blacklist?
It seems like a serious criminal conviction is required and we haven’t seen that almost ever and not at all recently with clinics.
Update: note that as discussed in the comments, the FDA may treat non-compliant clinics, which don’t generally work within the IND system, in a different kind of way even if they are convicted of a crime. Clinic leadership could end up on the blacklist, but it’s much more likely they’ll face other kinds of punitive regulatory action.
The private stem cell clinics will never make it to the FDA’s debarment list, and perhaps you don’t understand what it is. It is a primarlily a list of clinical investigators (might also be sponsors) who have violated FDA clinical trial regulations (often times, patient entry criteria, or not using the exact approved form of the study drug) who have gone through an FDA internal administrative process and the end result is that the FDA bars the investigator from participating in further clinical trials as a sanction for the determined misconduct. There are lesser sanctions available. I did a couple cases back in the 90’s involving investigators at MD Anderson. Sometimes the FDA threatens to stop all investigations at a facility/university medical program based on protocol violations.
Therefore there’s no way a commercial stem cell clinic would get debarred, since they don’t do FDA approved clinical trials. They get enjoined from treating patients like Regenerative Science and the two pending cases.
rick jaffe
@Rick,
Yes, you are right. I was going to do an update to the post on this factor.
It is still possible someone at a stem cell clinic could end up on the list for a variety of reasons, but I agree far more likely FDA will address them/their conduct in other ways.