4 New Polls on FDA Regulation of Stem Cells

1. 

   Pete Shuster

   January 20, 2014 at 1:04 pm

   Check out my Stem Cell Clinical Trials group on linkedin to get more comments/reactions to the Poll: http://linkd.in/1mwhSh6
2. 

   Brian Sanderson

   January 15, 2014 at 12:58 pm

   Paul,
   I look at your questions and the options to vote for and I just can’t vote for any of them without the risk of misrepresenting my viewpoint.

   I’d agree with Richard A. Epstein that the FDA position has an “Alice in Wonderland” quality.
   http://www.manhattan-institute.org/html/lpr_17.htm#notes

   I also agree with the fundamental point raised by Epstein, there are two regulatory approaches:
   (1) Regulation by the FDA involves a complicated, costly, years-long premarket-approval process that keeps products and procedures off the market until the FDA is satisfied that they are safe and effective.
   (2) The standard devices by which the medical profession is regulated — the ex post review of medical procedures only kicks in when an event, such as a physician review panel, lawsuit, or patient complaint, triggers a response from a public authority.

   So the devil is always in the detail. For eample, I would argue that the FDA has no business interferring with Regenerative Sciences cultured autologous therapy. On the other hand, some iPSC method might be quite a different matter.

   One thing does seem apparent. A bureaucracy is typically created to meet some need — yet it always evolves to be an end in itself. Bureaucracies should, therefore, be dismantled from time to time.

   The FDA is primarily the responsibility of USA citizens but US hegemony makes it everyones problem. (FDA has beaten health regulators of other nations, like New Zealand, into mere clients.) Good luck to us all….
   1. 

      admin

      January 15, 2014 at 3:58 pm

      You make a good point on the polls. It’s always hard when designing a poll as one can be torn between making the poll have too many choices or too few choices.
      1. 

         Alex Denoon

         January 22, 2014 at 2:59 am

         Paul,
         I did vote, but I agree that matters are more nuanced than a simple serious of questions. By way of example, I would add that in most jurisdictions whether or not the cells should be regulated is not just a factor of the degree (and location) of manipulation, but is also influenced by the intended uses (“homologous use” in the US; “same essential purpose” in Europe).
         Alex

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