That much-anticipated public FDA stem cell meeting that was postponed from April will now take place in September and will have a much larger array of diverse speakers.
Many more voices at an FDA stem cell meeting are collectively a good thing, but delay is not.
The large and growing U.S. stem cell clinic industry makes it ever more important for the FDA to move forward quickly with clearer and more definitive guidelines on clinical use of stem cells. At the same time those investigators doing rigorous Phase I, II, etc. FDA-approved clinical trials on stem cells also need clarity. The current ambiguity that has been persisting for years is harmful.
Key questions need concrete resolution from the FDA. Are fat stem cells a drug? Besides some very specific cosmetic applications can fat stem cells ever be used in a homologous fashion? What about the use of bone marrow for conditions that intuitively seem clearly non-homologous such as brain, lung, and other conditions? What about devices? Marketing? The list goes on.
Looking through the participants it is striking how many different stakeholders are slated to talk, ranging from stem cell clinics to patients to associations to university representatives…and even to California’s own stem cell agency, CIRM. I’m very curious to hear what everybody has to say. Unfortunately due to prior conflicts, I cannot attend, but I’m hoping it will be webcast.
There are going to be a bunch of different opinions articulated at this meeting. Sometimes starkly opposing ones will be put forth one right after the other. Maybe this meeting will be a turning point for the FDA to provide a detailed regulatory roadmap for all of us and then consistently enforce what they say. Or maybe not.
If a year from now we find ourselves in basically the same gray zone situation as we are in today with stem cell oversight from the FDA and lack of consistency, then I’m guessing that there will be a near consensus amongst stake holders (despite their diverse opinions on the FDA when it comes to stem cells) that the agency failed in a big way because lack of clarity is harmful across the board.