Dear FDA,

The stem cell center clock is ticking on you.

Before the Trump administration rolls in to possibly tie your hands on a lot of important areas of oversight including stem cell clinics, you need to take bold action now.

Your CBER branch has been preternaturally quiet on taking actual regulating actions on stem cell clinics for several years now despite the fact that there about 600 such clinics in the U. S. operating without any FDA home loan approvals putting thousands of patients and the stem cell field in danger. Everyone knows that you are now aware of these clinics. One caution letter in a period of years is a drop in the container.

For these same past few years you have released draft guidances that if implemented would substantially change  the way you regulate stem cells in ways that would quite helpfully stop the mushrooming stem cell clinic industry.

You  also held two public meetings on come cells in 2016, which was historic, and you received each verbal and written comments from stakeholders. The REGROW Act is history and the Cures Act is now regulation, with important language reinforcing your role in originate cell oversight. The clinics do not by any stretch out of the imagination meet the hurdles specified in Cures.

In short, much uncertainty is over. And you have  performed your due diligence. The time is right  to tackle the particular dangerous stem cell clinic problem. You have  delivered clear signals that you feel strongly about proper come cell oversight including via a late Nov opinion piece in the NEJM   only a few days ago. But words are not enough.

Concern a large coordinated series of warning letters in the next couple weeks towards the scores of  clinics grossly violating your regulations simply by experimenting on thousands of patients for profit with unapproved drugs.   Now is the time.

After Trump’ ersus inauguration all bets are off as to whether the brand new administration’ s FDA could still do anything about this severe problem. Strike now before his inauguration and create a profound positive difference.

Best regards,

Paul Knoepfler

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