It’s been a big 2 weeks in terms of media interest in talking about the upcoming FDA meeting on stem cell oversight taking place in just a few weeks. There are many questions about this meeting and I’m planning to tackle some of the questions in upcoming posts including next week.
These questions include, “who are the specific individuals attending and what are their perspectives?”
What exactly are all the organizations that are on the agenda and what are they going to say?
Another big question follows: “What’s the FDA going to say at this meeting?”
The list goes on and on, but the biggest question of all is what will be the outcome of this FDA stem cell meeting in terms of actual actions?
Will the FDA stick with its draft guidances that would for example make fat stem cells a drug and if it does, what will that mean for the hundreds of stem cell clinics using fat stem cells on patients without the FDA’s OK?
It could well be that the FDA will stick with the guidances but at the same time practically speaking do next to nothing in the real world about all those clinics seemingly not following the rules.
Could the FDA weaken its stance and end up going in the other direction in terms of less oversight?
It’s hard to know.
I will go out on a fairly safe limb to predict that the FDA’s actions following the meeting are likely to make no one happy.
I doubt the FDA will back down, but I also think it’s a long shot that the FDA will suddenly become more active in dealing with the US stem cell clinic industry despite evidence of it having nearly 600 unapproved stem cell clinics and growing fast. I hope I’m wrong about that latter prediction.
Whatever the FDA does after this meeting we can also bet that it won’t happen quickly. Still it is possible that in 2017 we may see an FDA that takes some kind of more pronounced action on stem cells to protect patients and the stem cell field. Another thing they could do is grant breakthrough designation to one or more promising stem cell therapies that have rigorous data supporting it next year.
When it comes to the FDA, though, I’ve learned that change doesn’t come easy.