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.
So loss of the company’s inventory is more important than patient safety? Can’t see this injunction lasting long.
“… the infections all occurred because one physician at an Ohio hospital repeatedly failed to follow package instructions meant to ensure sterility.”
“Judge Kinkeade said that no other infections have been reported and that the company recalled the products associated with the four infections. “So, there is not a risk to the public,” the judge wrote.”
So the company did lose inventory and the judge did consider patient safety. This issue at hand is losing ALL of its inventory for ALL of its products, even the ones that were not implicated in the infections. That’s ridiculous!
Not really. The organism contaminating the product was mycoplasma hominis. It was found in all of the product samples checked. There was no attempt to culture mycoplasma prior to using the amniotic tissue. If they are not checking for contamination of this product, they are not checking on any of their products.
The product implicated in the infections was not the same product that the FDA wants destroyed. An injectable product was implicated in the infections seen only in patients of one doctor. A warning letter applies to the injectable– basically the same letter BioD and Mimedix has received stating that the FDA considers injectables more than minimally manipulated and wants them regulated as a biologic. The product that they want destroyed is a patch. The patch is terminally sterilized via radiation.