I have several doctor friends who in the early days of cell therapy years ago argued that autologous cell therapies should be considered the practice of medicine - like stem cell transplants - and not require regulatory approval like drugs or devices. Indeed some of the motivation for the creation of industry self-accreditation bodies like FACT was to attempt to convince regulatory agencies that cell therapy products were best regulated by medical industry bodies. The FDA and other regulatory agencies were engaged in this discussion - they heard, they listened...and in large part they disagreed. My doctor friends came to grips with that reality and worked with the FDA to help create a regulatory framework that they now work within.
Even under the strictest regulatory frameworks there are some types of products which do not require formal approval. This blog will not be an overview of the regulatory distinctions between - for instance - s.351 and s.361 products (per FDA) but suffice it to say the differences between the products which do and do not require formal approval are, by now, fairly well defined in both US and Europe (albeit the latter only more recently). Furthermore, the regulatory agencies are eager to engage in dialogue with anyone who has questions about the proper regulatory pathway for their product.
And yet...there are those even now in the US and Europe who attempt to skirt the regulatory framework by conducting unauthorized and/or non-compliant clinical research and/or offering for sale commercial products without regulatory approval despite them falling clearly under the rubric of the regulatory requirements that such products be approved for such purposes.
It's one thing to be offering clinical products in unregulated markets that would would be or are regulated in other markets. I've previously opined here about the medical tourism industry and the issues it raises. But trying to conduct clinical research or sell clinical therapies that are not approved, in markets where there are clear rules governing the authorization to do so? Really?
Regrettably, yes. Two recent examples are described below. I'm not here to cast aspersions, don't want to spark any skirmishes, and certainly have no basis for suggesting impropriety on the part of those involved in these examples. I refer to these examples because they are recent, part of the public record, and, in my opinion, exemplify actions which should justifiably be called out and discouraged (if not penalized).
1. The first example comes out of Europe as described in recent reports in Science, MedPage Today, etc where the Lancet recently retracts a published article stating "... the editors rejected Dr. Strasser's assertion that products of tissue engineering are not medical products and therefore not subject to the Good Clinical Practice requirements."
Following is the report from MedPage Today (5 Sept 2008) :
Lancet Retratct Article on Incontinence Cell Therapy - Free Legal Forms
2. The second example comes from the US. Below is a copy of a recent letter sent to Regenerative Sciences, Inc (doing business as Regenexx) by the FDA .
FDA Warning Letter to Regenexx (Regenerative Sciences Inc - RSI) - Free Legal Forms
There are only three possible explanations I can come up with for why anyone would act as these two teams of people have done in clear contravention of the guidelines regulating their actions: (a) they simply don't understand, (b) they are looking to wage a fight or make a point, and/or (c) they believe their license to practice medicine supersedes regulatory authority (an argument long-ago tried, tested, and proven a loser). None of those reasons are justifiable in the circumstances.
In some instances, those who push the envelope help to shift the paradigm and improve the system they buck against. Even civil disobedience can - at least in retrospect - be occasionally justified if not even heralded as the impetus for positive change. This is not that.
This is playing with people's lives in clear contravention of the rules. That's not to say the FDA always has it right or that there are not issues to discuss or changes to make. The fact that neither of these treatments appear to pose any real risk to patient safety is certainly part of the argument for relaxed regulatory controls - I understand. But does that justify flagrant contravention of the guidelines as they exist using patients as pawns in the argument?
There are other ways to make this case. Go to a jurisdiction where the treatment is permitted, employ patient groups to lobby or litigate, engage industry and FDA in discussions to affect change in the regulatory regime.
Dear Doctor. The fact these therapies may be relatively harmless is no excuse for acting outside the regulatory framework and guidelines created to protect those people you're treating - agree with it or not, like it or not. Thanks.
--Lee
5 comments:
so does FACT regulates cell therapy and cell products manufacturing today or FDA does? or both of them?
and what is situation with cell therapy regulation in US, Canada, Europe and Asia? I think FDA regulates only cell and tissue products manufacturing in US? We can extrapolate FDA rules to other countries. But FACT suppose to be international.
sorry in previous comment i meant "we can not extrapolate FDA rules to other countries"
can't modify my comments here
FACT (http://www.factwebsite.org) is an industry body which sets standards and then accredits facilities against those standards. Participation is voluntary. It has no regulatory power and no official status with FDA or any other regulatory body but unofficially FDA officials will tell you that FACT accredited facilities are considered to be lower risk all things being equal.
FACT standards have now been adopted in other countries outside the US with inspection and accreditation programs set up in some of those countries.
This is also true of FDA rules. Some countries have mimicked or closely mimicked FDA rules.
FDA regulates any biological product coming into the US regardless of where it is manufactured so it has the authority - if not obligation - to inspect a facility outside the US if products made at that facility are being imported into the US.
Hope that helps.
thanks, it helps
Errata Statement re: Regenexx
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...
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