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cliveandrews

Should I testify at this FDA public meeting?

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The FDA is about to strike again. Five years ago, the agency moved to begin regulating the use of adult stem cells as drugs. While it succeeded at curtailing the use of cells that have been expanded in culture (i.e. grown to greater numbers in an incubator), it did not gain control over "same-day" cell procedures in which cells are taken out of the patient's bone marrow and immediately re-injected in their original number. Lately these "same day" procedures have gained significant traction as viable treatments for orthopedic conditions, and the FDA apparently wants to put a stop to it by passing yet more regulations to classify these cell preparations as drugs. They're holding a "public meeting" later this year to solicit viewpoints on the issue:

https://kg236.infusionsoft.com/app/hostedEmail/85850/79214ccd9d246826/T

This issue is of great personal importance to me. However, I'm uncertain whether I should attend this event, because I surmise that their intentions are a forgone conclusion and that this is just a perfunctory formality to make it look like the FDA is open to opposing points of view. I would hate to plead for my freedom to people who have no respect for it. Maybe a politely worded, scathing denunciation of their actions would be appropriate? In that case, how harsh would be too harsh?

Any thoughts on this would be appreciated.

 

 

Edited by cliveandrews

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My first thought is that based on your posts in the past, it's a really good idea to assert your thoughts on this to the people actually making regulatory decisions. While it is true that your freedom to act has been denied, the FDA is simply a regulatory agency premised on a notion of a good for society. As far as I see, things like this aren't a formality, the FDA really wants information to decide what is best for society, not acting as a dark cabal.

My point is that thinking of this as a plea for freedom is probably a bad approach. You may be better off thinking of it as a way to assert yourself, that you as an individual are quite alright and capable of saying these procedures are critical for you. The problem of the FDA is less that it denies things, more so that it is overly concerned that it must protect people so ends up being cautious. So you could talk about 1) their caution being misplaced, and 2) how people like you are well aware of how the procedure works.

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I don't know the answer, but I would want to know if any person or group has successfully petitioned the FDA in such a forum with some degree of success. I'd suspect there must be at least some such cases. If so, what distinguishes them? Did the petitioners adopt some particular tactic, did they ask for some limited exception? Are the successful petitioners out there and willing to give advice? Who else would be on your side? Are there other patients in some type of support group? Are there some practitioners or researchers or companies that share your goal; and, if so, is there some way you can combine your efforts?

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