Hot off the press: The other shoe drops on stem cell clinics

Hot off the press: The other shoe drops on stem cell clinics

The Washington Times reported today that the FDA has filed permanent injunction lawsuits against the two most high profile U.S. stem cell clinics.
Here is the article:

Both of these clinics received FDA warning letters last year indicating that their operation violated federal law. Today’s action by the FDA in the logical and inevitable conclusion of the FDA’s multi-year effort to eradicate stem cell clinics using autologous stem cell treatments.

See my end of year post, laying out what the FDA did on stem cells and what’s coming:

In many of my past posts, I’ve lamented that the initial target of the inevitable FDA action would be the Florida clinic made infamous by causing partial blindness in three patients, and yes, that is one of the two clinic sued by the FDA today. The other was the stem cell network run Mark Berman and his partner. They stand accused of, among other things, using a toxin as part of the stem cell treatments.

I haven’t read the injunction papers yet, but it’s a safe bet that the FDA is arguing that the therapy is 1. an unapproved new drug, 2. misbranded and 3.adulterated. Dollars to donuts the FDA is also going to cite numerous violations/inadequacies with the manufacturing facilities/processes or in FDA speak, cGMP (current good manufacturing practices) and GTP (good tissue practices).

Challenging times are ahead for the two clinics as well as other high profile stem cell clinics who are on the FDA’s radar screen.

More after I’ve looked over the injunction papers.

Rick Jaffe, Esq.

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