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TOPIC: Unapproved SC products marketed in the US

Unapproved SC products marketed in the US 23 Jun 2015 07:13 #4723

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Alexey Bersenev wrote a quite interesting article on the subject, which has been a very HOT topic of discussion at the Cell Technology groups at LinkedIn in the past few years.
In the past I have spent weeks and weeks of studying the legislation and reading expert opinions, which really culminated in the language now recently issued by the FDA, which seems to be quite clear.

The question is- what happens with all that stuff i.e. products, which sneaked on the market by the manufacturer "claiming" the product is a socalled "361 product" which doesnt require FDA -drug approval, but in actual fact DOES require this, but which approval is NOT ENFORCED by the agency???

No one knows, but as stated above- Alexey wrote a piece on it : Self-launched 361 commercial “stem cell products”

An excerpt:

Business model
Despite FDA early letters (for Parcell and AlloSource in 2011), SC companies continued to do the same thing over and over again in 2013 (Osiris) and in 2014 (RTI Surgical). Very recent deal between Stryker and Osiris on transformation of Ovation into BIO4 is an example of continuing trend. Why didn’t they learn? Did they miss those FDA letters? Did they consult with FDA on classification of their products? Do they actually care at all about FDA’s “current thinking”? NO, NO and NO! It indicates that self-launch and self-claims are working well for a profit. It seems to me, their regulatory compliance people did not do their homework or were asked to follow the scheme:
- don’t consult with FDA!
- self-launch it with fancy label “stem cell”!
- pitch it to surgeons – they like to be innovative and “push an envelope”!
- enjoy a ride $$$ until FDA will crack down on you.
Why this business model is still thriving? Well, first of all, FDA may never come to you (they have limited resources) if you don’t kill any patient. Second, if FDA will sniff you, it may take 1-2 years before an audit is done, months to report, 1 year for responses and so on. Third, companies may get away with it by pleasing or negotiating with FDA (Osiris did it for Grafix) – changing marketing language (Biomet removed all osteogenic cells/ MSC-related language from description of Cellentra as advertised earlier in 2012) , narrowing down therapeutic indications, promise to do some post-marketing studies. Another possible model is divesting a product (Osiris sold Osteocel to NuVasive), partnership with big players (Osiris – Stryker deal).

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Unapproved SC products marketed in the US 23 Jun 2015 11:24 #4725

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Fas,
This excerpt from an FDA letter to Osiris makes the point

Please be advised that in order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product's intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]. 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.


The author is probably correct in assuming that until someone dies from a misguided procedure involving questionable cells the FDA will not pursue legal remedies.

The dilemma is that an outcome such as a death could so damage the reputation of regenerative medicine that recovery could take decades. In the meantime fraudulent procedures do nothing but create doubt of efficacy. I don't know how the FDA can regulate it. I don't think they do either.

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Unapproved SC products marketed in the US 25 Jun 2015 06:02 #4728

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The dilemma is that an outcome such as a death could so damage the reputation of regenerative medicine that recovery could take decades. In the meantime fraudulent procedures do nothing but create doubt of efficacy. I don't know how the FDA can regulate it. I don't think they do either.


All the present applications are basically "simple" non-evasive orthopedic- and wound healing applications. It is extremely unlikely that anything serious occurs, since all apps are based on adult cells and nothing risky like Esc´s or iPC´s ( which one reads more and more that even Induced Pluripotent Cells- stemming from adult tissue, induce carcinogenic cell growth).

Anyway- the first generation gear from Genzyme which Aastrom bought from Sanofi does not blow anybody away- which also happens with the Grafix and all other stuff, which can be classified as second generation. My view is that since regulations by the FDA were chaotic in the past and put cell app developers years back and were wasting time and shareholders money, they should be allowed to continue as first movers with the present products. Any new developments according to new now existing regulations. :whistle:

Time will tell. :nice:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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