As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier.
It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain suppliers are strong driving forces behind more patients being put at risk. Also, each supplier may enable dozens of clinics so there’s some logic here to the FDA putting energy into more oversight of suppliers.
The new warning letter went to supplier Stemell.
What an odd name, right?
I keep feeling like there’s a “C” missing in there. Is the idea that since the motto (see above) is “science beyond cells” that the “c” in cells isn’t needed? But at least some of their products are stem cells so I don’t know.
During a normal period of a couple weeks you’d think this warning letter would have been the main headline in the stem cell world, but as important as the letter is, so much more was also going on in including the sudden halt to some seemingly promising HSCT autoimmune trials and Google saying its going to no longer run ads for unproven stem cells and gene therapies. And then there was the resignation of the leader of a prominent stem cell clinic firm.
What a busy, chaotic sphere at the moment.
Getting back to the new warning letter to Stemell, which was addressed to its leader Peyman Taeidi, the letter noted that the products are in the FDA’s view unapproved drugs. Hopefully this helps to dispel the myth that perinatal products are somehow automatically 361 non-drug products across the board.
It’s very interesting too that the FDA specified that the fact that the firm is “just a supplier” didn’t seem to obviate the need for approvals. Here’s the relevant passage:
“Your website includes certain disclaimer language, including that “[s]tem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed,” but that “Stemell, Inc. is a supplier only … and … is not claiming to cure or treat any disorder or condition.” The Terms and Conditions of Sale section of your website further states, “The physician and the clinic are absolutely not allowed under Stemell, Inc.’s name to make claims for any cure or treating a disorder. If they do, Stemell, Inc. is neither responsible nor liable for any medical claims by the physician or the clinic.” (Emphasis added.) Your disclaimers do not alter the fact that your products are “drugs” and “biological products” within the meaning of the FD&C and PHS Acts, respectively.”
However, what about the other major perinatal stem cell-related suppliers such as here in California and the ones in Utah? What’s the difference in terms of the products and the FDA actions? Are those other products somehow not drugs? Or since they perhaps didn’t have CGMP problems, FDA views them as less of a risk and hence lower priority? Or something else is going on? Here’s a quote from the FDA PR accompanying the warning letter, which contains some words that should seem worrisome to stem cell suppliers in my view:
“We know that there are manufacturers and clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products. The FDA has consistently stated that this is not true,” said Acting FDA Commissioner Ned Sharpless, M.D. “This company failed to take appropriate measures to protect patient safety. The FDA will be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients. Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients.”
Also, take a look at the letter to R3 Stem Cell and its affiliates from some months back.
If the stem cell suppliers wanted to be much safer when it comes to FDA compliance they would just label all their products along the lines of “For in vitro use only. Not for use in humans.” But then most of the clinics wouldn’t buy them, right?
The perinatal arena remains complex and the FDA oversight continues to evolve here so it may become more consistent over time.