The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees?
Who is likely to say what?
If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have a satirical cartoon from some time ago I drew imagining such a future.
I’ve put together a “field guide” to the meeting in the form of a list of 10 bullet points.
- FDA speaks. The FDA is of course hosting this meeting and is presenting at it too. I’m very curious to hear what they have to say. I’d predict that they will present the case for their draft guidances including that fat stem cells are a drug and that their use is often non-homologous.
- Clinic picks and their customers/patients. The stem cell clinics and their favorite patients are out in force. Expect them to push for less FDA oversight of stem cells and in particular for not classifying fat stem cells as a drug or bone marrow stem cells used in a non-homologous fashion as drugs. Note that some of these clinics/businesses have been the subject of past FDA actions and others could be wondering if they might be contacted by the FDA in the future so it’ll be an interesting dance.
- Questions to think about regarding clinic talks. My advice to watchers of the meeting? Listen for unsubstantiated medical claims of safety and efficacy, impressive-sounding anecdotes, claims that publications of data are in the works, and assumptions that oversight is only harmful. Also consider who is making money off of stem cell marketing to patients and who stands to gain if there’s less oversight.
- Will the disturbing, but important topic of the 3 women who were recently blinded by a fat stem cell clinic in Florida come up? It should. At last week’s FDA science meeting on stem cells, Dr. Albini presented the cases of 3 women who were literally blinded by a Florida stem cell clinic at which fat stem cells were injected into their eyes. Interestingly, it is possible that that the so far unnamed clinic may itself be presenting at the meeting so I’m wondering if someone will have the courage to confront them about this disastrous outcome.
- J&J has its say. Johnson and Johnson, a biomedical powerhouse, is on the agenda. This m means that they are clearly interested in stem cell oversight. Will they advocate for less oversight? Or will they support the current FDA approach for the most part? What else might they say?
- Tissue banks out in force. Quite a few cell and tissue banking type of organizations are on the agenda. What might they have to say? Since presumably they have an interest in the freer use of stem cells and other materials, which creates more demand, I’d guess that at least some will advocate for less oversight, while others won’t.
- REGROW on stage? To what extent will the REGROW Act, which seeks to reduce FDA oversight, take center stage in some of the talks? This bill has largely gone off the radar this summer, but could make a comeback in the fall and this FDA meeting seems that it could be a springboard for REGROW fans.
- Will CIRM advocate for less FDA oversight again? The short answer is “yes”. How strong will CIRM’s words be at this FDA meeting? If they push fairly vigorously for less oversight how will that come off with so many stem cell clinics at the same meeting also pushing for less oversight? It could be a tightrope walk for CIRM as they are opposed to the clinics.
- Academic institutions have sway? There are some universities and academic researchers from such institutions slated to talk. What will they say? Less regulation is needed? The current system largely works but needs to be more efficient? Mixed bag? We could see more blurring of the lines.
- What happens after the meeting ends? This is the most important question to think about throughout the meeting. Will the FDA begin a period of more proportionate activity in providing oversight of the stem cell clinic arena? Will it pretty much stick with the status quo of doing next to nothing on stem cells (maybe 1 warning letter every year or two?) despite there being around 600 such clinics in the US today that largely lack FDA approval or licensing? It seems to me if the FDA is going to stick with the status quo then what’s the point of evening having these meetings so I’m hopeful that change is in the air. It might not come until 2017, but the odds are that the FDA will step up its game on stem cell clinics eventually.