For some reason, and for the life of me I can’t figure out what it is, up until now, the FDA has been extremely shy about confronting cord blood manufacturer/resellers. I can’t think of a single warning issued against these folks, even though they claim to their physician customers that their products are FDA exempt, which I have publicly doubted is the case. (See my post: http://rickjaffeesq.com/2019/02/08/is-cord-blood-um…-treatment-legal/
Per the NY Times today, that changed last Friday, and for those living under a rock, but with access to the internet, here is the NY Times article.
Here is the actual warning letter sent to the company on Friday, March 29, 2019.
Big surprise, the FDA takes the position the company’s umbilical cord stem cell product is an unapproved new drug, not an exempt or solely regulated under a Section 361 type HCT/P product, under 21 CFR 1271.10. Also, and again no surprise here, the manufacturing facility is not up to cGMP snuff.
If you read my stuff, you know what’s coming next procedurally: a response by the company in which they’ll claim they are exempt and a promise to endeavor to look into fixing some of the cGMP issues, dead time, FDA response that the compnay’s response to the warning letter is unsatisfactory. Maybe another response, then more dead time and thereafter, if the company still has the same name and location, an FDA injunction lawsuit.
If the FDA has performed inspections at other umbilical cord facilities, and there are a number of them out west, expect another warning letter or two.
What effect is that going to have on the doctors buying and using this and other company’s product?
In the short term, none, whatsoever.
Why? Think whack-a-mole, and some economic and market realities. The econmic realities are that cord blood products are typically cheaper or alot cheaper than the autologous fat/MSC/SVF surgical proceedures, and cheaper is more popluar obviously, since the entire market is cash/non insurance reimbursable. Second, less training and equirement outlays for the docs for injecting products manufactured by others. Even chiros and naturopaths are getting into the non-autologous market. Third, skyrocketing demand based on the ineffectiveness of current treatment for many othopedic and other conditions. When you combine all three, you’re going to need a whole lot of hammers to whack all these moles.
But at least I give the FDA credit for going after the manufacturers, or the discredit for interfering with people’s rights to get the treatment they want without government interference. It all depends on your perspective.
AND NOW FOR THE MORE TO COME!
In a statement released eariler today, April 3, 2019, the outgoing FDA Commissioner issued a public statement about this warning letter and 20 others that have recently been filed. These are not on the FDA’s web site, but I suspect they soon will be. We’ll see if it includes the usual cord blood suspects in the western part of the country or if it includes folks other than manufacturers.
Here is the commish’s public statement:
Rick Jaffe, Esq.