The FDA has delayed the planned big April public meeting on stem cells until later this year.
Basically, the reason given is that more time is needed for stakeholders to comment.
It will be interesting to see if the FDA expands the meeting beyond the 1-day format, which was going to allow each speaker only 3 minutes. It would be helpful I think if the FDA held the meeting in a more centrally located city as well. I’m hoping now I might be able to attend.
The delay in this meeting risks leaving the stem cell regulatory sphere related to four recent draft guidances up in the air for a longer period of time, but we’ve seen from the recent stem cell clinic warning letter that the FDA will still take action based on its current thinking. You can also read my interview last week with the FDA on this meeting and the draft guidances here.
The announcement on the FDA website reads:
“There has been considerable interest in the Public Hearing, “Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products,” scheduled to take place on April 13, 2016. Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has postponed the hearing, which will be rescheduled later this year at a date to be determined. The agency also intends to schedule a scientific workshop to gather information from manufacturers of cell based products, clinical researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics.
Information on the rescheduled hearing, including date, location and registration information, will be made available on FDA’s website and will be published in the Federal Register. We will announce the dates for the hearing and the workshop in the near future.
FDA’s announcement will contain information on how stakeholders interested in speaking, including those who were scheduled to speak at the hearing on April 13th, can sign up to speak at the rescheduled hearing.”
i m suffeing fromm this bulbar problem right now i cant even swallow anybody out there rcan help tks
don mg
“The agency also intends to schedule a scientific workshop to gather information from manufacturers of cell based products, clinical researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics.”
I believe the FDA just raised the bar for the industry participants and may be looking to separate the anecdotal evidence from the real, quantitative clinical data.
Translation “We just got a big donor lobbying for us to vote one way or another, we’ll have to find a way to justify our flip-flopping”.
I also hope that FDA will listen to all voices including people that have had treatments but have only lost money and whose quality of life is reduced by these non-approved drug treatments.
I’m speaking from personal experience, as my father was treated (if that’s what it was) in Mexico for type 2 diabetes with SVF. Even though this was autologous, he had a severe immune shock and spent a week on a drip in the hospital. Needless to say he still has diabetes, but is $8,000 poorer for the experience.
It’s not all good out there, but you’re hearing a lot from people who were lucky enough to be the one in a hundred with some good results and from others who simply want to shout at the FDA due to frustration. But there are those whose experiences were simply criminal but won’t voice their opinions because they are deeply depressed. And some who also can’t because they are dead.
Listen to everyone FDA.
@ALSad
Please prove and/or expand your a) b) and c) comments. There are no supporting facts to what you are stating.
As a stem cell recipient for Multiple Sclerosis and ACL injury, I’m hoping this delay means that the FDA will listen to ALL voices and not rush to judgement to stifle medical innovation. What @ALSadvocate mentions above is how thousands of patients feel who’ve already had quality of life improvements being treated with our own cells. ” (a) it doesn’t make any sense (b) patients see enormous benefits (c) no safety issues with own cells.”
As we’ve discussed before, medical tourism is at an all time high because of FDA’s erroneous regulations. Too many of us have been treated and the word is out. Patients are seeing regeneration where there was degeneration. Lives are being saved. There are too many patients who are N=1. Patient voices/experiences have been marginalized as emotional, anecdotal, or political. I’ve experienced a lot of this type of marginalization on this blog. When PFSC initially started interacting with you 4 years ago, you spoke often of bridging gaps. I still have hope that we might be able to!
I AM N=1! My patient voice matters, and our group speaks for the thousands of “No Option Patients” who are too sick to speak for themselves!
FDA should realize that it is high time it quit making-up fake regulations that sound stupid to even the uninitiated in stem cell area. It might sound extremely intelligent to the folks writing these regulations, but if they just step out of their hula hoop, they will see that outside the hula hoop no one is dancing by FDA guidelines, because (a) it doesnt make any sense (b) patients see enormous benefits (c) no safety issues with own cells.
Its high time FDA admits it is wrong, apologize to patients and advance unhindered practice of medicine.