Dear FDA,
The stem cell clinic clock is ticking on you.
Before the Trump administration rolls in to possibly tie your hands on many important areas of oversight including stem cell clinics, you should take bold action now.
Your CBER branch has been preternaturally quiet on taking actual regulatory actions on stem cell clinics for several years now even though there about 600 such clinics in the U.S. operating without any FDA approvals putting thousands of patients and the stem cell field at risk. Everyone knows that you are now aware of these clinics. One warning letter in a period of years is a drop in the bucket.
For these same past few years you have issued draft guidances that if implemented would substantially change how you regulate stem cells in ways that would quite helpfully put a stop to the mushrooming stem cell clinic industry.
You also held two public meetings on stem cells in 2016, which was historic, and you received both verbal and written comments from stakeholders. The REGROW Act is history and the Cures Act is now law, with important language reinforcing your role in stem cell oversight. The clinics do not by any stretch of the imagination meet the hurdles specified in Cures.
In short, much uncertainty is over. And you have done your due diligence. The time is right to tackle the dangerous stem cell clinic problem. You have sent clear signals that you feel strongly about proper stem cell oversight including via a late November opinion piece in the NEJM only a few weeks ago. But words are not enough.
Issue a large coordinated series of warning letters in the next couple weeks to the scores of clinics grossly violating your regulations by experimenting on thousands of patients for profit with unapproved drugs. Now is the time.
After Trump’s inauguration all bets are off as to whether the new administration’s FDA could still do anything about this serious problem. Strike now before his inauguration and make a profound positive difference.
Best regards,
Paul Knoepfler
I had a question?? I have heard that even if the FDA wanted to take action to make the guidelines the law that congress would have to vote on it? Is that true? I figured that you would know if thats the case.