The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the judge’s order.

In its inspections, the FDA reported that it found some of the products were contaminated with pathogens. The company apparently disputes some aspects of the FDA’s claims and sued the FDA after which the judge intervened to block the most stringent of the FDA’s orders:

“Amniotic Therapies sued the FDA August 19 in the U.S. District Court for Northern Texas, asking Judge Ed Kinkeade to declare that the order exceeds the FDA’s authority, that it is arbitrary and capricious and to force the FDA to suspend the order until the legal case is resolved. The company filed an emergency temporary restraining order at the same time, asking Kinkeade to block the FDA’s order.”

It remains unclear to me how this legal case might play out. Typically the FDA is given wide legal authority. I’m not sure if the FDA can appeal.

Here’s more of the report on the judge’s action:

“Kinkeade ruled that same day to stay the FDA’s order, except as it applies to distribution of new product by Amniotic Therapies, estimating that destroying current inventory would cost the company about $360,000.

“Here, the FDA order was based on [the FDA’s] conclusion that there were ‘reasonable grounds to believe’ that products manufactured by plaintiff pose a danger to health rather than an actual finding that plaintiff’s products in fact pose a danger to health,” Kinkeade wrote, noting that Amniotic Therapies recalled the lot involved with the infections at St. Vincent’s.”

In part this case seems to boil down to different views of potential risk of infection from these products.

Kinkeade’s ruling doesn’t appear to pertain to the FDA indicating in the warning letter that the products in question are in their view unapproved drugs for which there is no IND and also there is no BLA.

There’s a lot going on in this case so it’ll be interesting to follow.

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