The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery.
What’s going on here?
With Halloween coming, one has to wonder if the FDA letter to Osiris was more like a trick or a treat. My take is that it sure doesn’t seem like a Snickers bar.
The FDA letter of September 26th detailed issues that an FDA inspection had found with some of the company’s products.
More specifically, the FDA seems on the face of it to define the company’s Ovation® and Grafix products as biological drugs and to suggest that a BLA and an IND are probably needed. Of course there could be more to the story going on behind the scenes and the FDA never comments publicly on such cases so maybe this a case where appearances can be deceiving with this letter leading those of us who are outside the loop to misinterpret it. But a lot has been said about this situation in the public domain by others including the company itself that is notable.
Osiris put out a PR on October 21 that seemed to put a noticeably positive spin on the FDA visit and associated untitled letter using words like the company is “pleased” and “excited” about the situation with the FDA, which it characterized as related to an “agreement” between the two.
A storm erupted when Adam Feuerstein wrote a piece on the financial site, The Street, about this situation entitled in part, “FDA slaps Osiris For Misleading Medical Claims…”
Osiris quickly issued a counter statement slapping Feuerstein for his supposedly misleading piece leading to a barrage of comments on Twitter.
Osiris called Feuerstein’s piece “wholly false“, “wholly erroneous“, and “reckless“. It also implied that it could file a lawsuit about this. The Street piece, in its original form, did have one error because it apparently called the untitled FDA letter a “warning letter”. A warning letter is a more serious action than an untitled letter from the FDA so the distinction is important. But this was corrected and as for the rest of the content in Feuerstein’s piece…I’m not clear on how it was so off base as the company asserts.
Osiris went further in a later PR indicating it believes that a BLA is not required for Grafix and that the product is NOT a biological drug. These statements seem puzzling to me given the FDA letter’s language.
So does Grafix, for example, require a BLA or IND or not? Is it a 351 drug or a 361?
Here’s what Osiris said publicly via PR (emphasis mine):
Grafix, indicated as a wound cover for the treatment of acute and chronic wounds, is regulated solely as a human cells, tissues, and cellular and tissue-based product (HCT/P) under section 361 of the Public Health Service Act (PHS Act).
Direct verbiage from the FDA letter to Osiris includes this statement that sure seems to suggest otherwise, at least to me (emphasis mine):
You are currently registered with the FDA to screen, test, package, process, store, label, and distribute a variety of amniotic/chorionic-based products. These products include: Ovation®, Grafix PRIME®, Grafix CORE®, and Grafix XCTM, all of which are intended for use, among other things, in the repair, replacement, or reconstruction of tissue defects, as well as wound healing and tissue repair. These amniotic/chorionic-based products are human cells, tissues, and cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, these products are HCT/Ps that do not meet all of the criteria in 21 CFR 1271.10(a) and therefore, are not regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations in 21 CFR Part 1271.
What the heck?
Are you confused too? Wait, there’s more from the FDA letter:
The HCT/Ps referenced above are drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)].
That is a very clear, serious statement from the FDA defining Osiris products as biological drugs.
Osiris says in its PR, “After discussions with the FDA, the regulatory status of Grafix is confirmed”.
Confirmed as what? Drugs requiring INDs and/or BLAs…or simply cell and tissue products….both…..wait, what?
The FDA goes on to say:
None of the amniotic/chorionic-based products described in this letter are the subject of an approved biologics license application (BLA), nor are there INDs in effect for any of these products. Based on this information, we have determined that your actions have violated the Act and the PHS Act.
That sounds like another unambiguous statement from the FDA of not such good news for the company.
If it were me, I wouldn’t want this FDA letter in my corporate Halloween candy bag.
I contacted the company twice in the last few days for a response to this situation, which I will print verbatim, but no reply as of yet.