It has been pointed out to me by legal counsel that the 25 July 2008 letter from the FDA to Regenerative Sciences, Inc regarding what FDA observed as apparent "violations" of FDA regulation by Regenexx, was not a "Warning Letter" as that term is officially defined but rather an "Untitled Letter" which has less or no formal effect.
My previous reference to the letter as a "warning letter" was a colloquial rather than legal use of the term. In any event, to avoid possible confusion, I hereby formally point out that the letter was not a "Warning Letter".
Despite the FDA's observations of what it then said appeared to them as Regenexx "violations" of FDA regulation in that Untitled Letter, since the date of the letter the FDA has not followed up with any Warning Letter, Cease and Desist Letter, or sought any other relief in court either in an action of its own or in the action brought against the FDA by Regenerative Sciences, Inc.
This fact has emboldened many to believe that the FDA will not take any action to remove Regenexx from the market despite its observations in 2008 that Regenexx appeared to violate the existing FDA regulatory framework.
Some take this one step further and believe that by its lack of action the FDA has demonstrated it now believes the product does not, in fact, violate the regulations. Others are convinced the FDA's lack of action is merely a lack of action and not a change of conviction. In the face of a lawsuit by RSI, after all, the FDA has to pick its battles carefully.
Only time will tell...
3 comments:
Stem Cell Therapy Clinics and regenerative medicine: The amount of information in the media, both professional and popular, is huge. Nonetheless, most of it, although interesting and supportive for further development, is not applicable for present patient's needs. If we want to evaluate the current potential of a new therapy, the most important parameter is how close it is to clinical utilization.
"Centeno circumvents the FDA", says Denver Post, after "a letter in 2008 warning him that lack of FDA licensing for Regenexx appeared to be in violation of the Public Health Service Act".
Meanwhile, the "International Cellular Medicine Society, which Centeno helped establish to set professional guidelines for adult stem-cell therapies and now counts 300 physicians in its ranks, is meeting this month with the FDA to discuss the issue of whether a patient's own cells classify as a regulated drug."
It will be interesting to see the fallout from this meeting.
In another development, a study was published last month in the peer-reviewed journal Current Stem Cell Research and Therapy detailing the recovery of 227 Centeno patients. Using high-resolution MRIs, the study showed no patients developed tumors or other serious complications from the treatment.
"The safety has been quite good," Centeno said.
Click Here for the full story from DenverPost.com
Thank you for explaining this!
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