The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs.
That would be a good thing for patients who are often being put at risk by many of the clinics. This is the reality no matter what some of the patient advocates who promote the clinics might say. Such finalized FDA regs that unambiguously state that, for example, fat stem cells are drugs, would be bad news for the clinics that are after patients’ money. Update: It is important to note that not all patients or patient advocacy groups are pro-clinic and anti-FDA. Every patient has a different story and I’ve met many that know the clinics aren’t some kind of Robin Hoods of stem cells.
It is perhaps not surprising then that at the planned upcoming public FDA meeting on stem cell regs in April, there’s going to be a crowd of anti-FDA, anti-regulation forces converging to speak. The agenda of this meeting, with a few notable exceptions, reads like a who’s who of the for-profit stem cell clinic world. I’ve pasted the agenda at the bottom of this post.
An interesting additional factor going on here is that there are some highly respected organizations also coming to the meeting that, reading the tea leaves, are also almost certainly going to advocate that the FDA be less comprehensive in its regulation of stem cells to accelerate translation. For instance, CIRM recently has made some statements about the FDA needing to speed up and maybe not be as strict.
CIRM probably realizes that there will be many folks at this FDA meeting who have no particular interest in participating in the standard FDA approval process at all. These stem cell clinic folks may cheer on statements from CIRM, if such are made, that come off as wanting a weaker FDA regulatory sphere for stem cells. I cannot imagine that CIRM would want that and I know that CIRM does not support these clinics.
As a result, there’s a vital need for CIRM to choose its approach to this meeting very carefully and cautiously. It may be a fine tightrope to walk. Accelerating evidence-based treatments based on stem cells is one thing, but weakening much-needed regulatory oversight that leads in the near future to clinics taking more money from more patients that they put at risk is quite another.
In short, CIRM’s agenda is very different than that of the clinics. Yet the stem cell clinic crowd could even be hoping to use CIRM’s words at this meeting for their own future publicity. They might even try to get their picture taken with CIRM staff to use on their websites. Historically the stem cell clinics have been very anti-CIRM, but that doesn’t mean that they won’t pounce on a PR opportunity if it arises.
The Alliance for Regenerative Medicine (ARM), which has done and continues to do amazing things, is also likely to push for a relatively more permissive stem cell regulatory construct at this meeting too. I hope that they are cautious not to align themselves with the dubious clinics. The membership of ARM consists of good citizens of the stem cell and regenerative medicine biotech community who work with the FDA and follow regs. This is a night and day difference from the stem cell clinics.
Regardless of how this meeting plays out, it will be fascinating to see and hear the views at this unprecedented gathering.
The agenda as of Feb. 10.
Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15 Public Hearing Draft Agenda April 13, 2016 FDA White Oak Campus 10903 New Hampshire Ave, Building 31, Room 1503, Great Room Silver Spring, Maryland 20903
8:00-8:15 AM: Presiding Officer Opening Remarks and Introduction of Panel Members 8:15-9:46: Session 1 • 8:15-8:18: Allosource • 8:19-8:22: Atlanta Medical Center • 8:23-8:26: AZ Pain Centers • 8:27-8:30: Birth Tissue Recovery, LLC • 8:31-8:34: California Stem Cell Treatment Center and Cell Surgical Network • 8:35-8:38: CAREStream America • 8:39-8:42: Celebration Stem Cell Center • 8:43-8:46: Centeno-Schultz Clinic • 8:47-8:50: Harvard Apparatus Regenerative Technology • 8:51-8:54: INCELL Corporation LLC • 8:55-8:58: Intellicell BioSciences • 8:59-9:02: Johnson & Johnson • 9:03-9:06: LifeLink Tissue Bank • 9:07-9:10: LifeNet Health • 9:11-9:14: Long Island Plastic Surgical Group • 9:15-9:18: MedCentris • 9:19-9:22: Info Health Global • 9:23-9:26: Millennium Medical Technologies • 9:27-9:30: MiMedx Group, Inc. • 9:31-9:34: Minnesota Medical & Rehabilitative Services • 9:35-9:38: Musculoskeletal Transplant Foundation • 9:39-9:42: National Spine & Pain Centers • 9:43-9:46: Oregon Regenerative Medicine 9:47-9:55: Questions from panel 9:55-10:25 Break 10:25-11:56: Session 2 • 10:25-10:28: Organogenesis Inc. • 10:29-10:32: RTI Surgical • 10:33-10:36: StemGenex, Inc. • 10:37-10:40: U.S. Stem Cell Inc. (FKA BIOHEART Inc.) • 10:41-10:44: Robert W. Alexander, M.D. • 10:45-10:48: Scott R. Graham, M.D • 10:49-10:52: Shay Bess, M.D. • 10:53-10:56: Julie Cerrone • 10:57-11:00: Ann A. Connolly • 11:01-11:04: Shawn Connolly • 11:05-11:08: Elio Coradin • 11:09-11:12: Terri Coutee • 11:13-11:16: Charles S. Cox, Jr., M.D. • 11:17-11:20: Pamela Fricke • 11:21-11:24: Brian Gates • 11:25-11:28: Jarvis P. Green • 11:29-11:32: Candace Hart • 11:33-11:36: David Jacobs, M.D. • 11:37-11:40: Carolyn M. Salafia, M.D. • 11:41-11:44: George U. Sauter • 11:45-11:48: John Klimkiewicz, M.D. • 11:49-11:52: Samantha Wilkinson • 11:53-11:56: Rebecca Baergen, M.D. 11:56-12:00 Questions from panel 12:00-1:00: Lunch: Ala Carte items will be available for purchase on site 1:00-1:35: Session 3 • 1:00-1:03: MaryAnn Chirba, J.D. • 1:04-1:07: Case Western Reserve University • 1:08-1:11: Indiana University School of Medicine • 1:12-1:15: Wake Forest University School of Medicine • 1:16-1:19: Navigant Consulting • 1:20-1:23: OrthoKinetic Technologies, LLC • 1:24-1:27: Parenteau BioConsultants • 1:28-1:31: Alston & Bird LLP • 1:32-1:35: Topher Stephenson, M.D. 1:36-2:52: Session 4 • 1:36-1:42: Alliance for Regenerative Medicine • 1:43-1:49: Alliance of Wound Care Stakeholders • 1:50-1:56: American Association of Tissue Banks • 1:57-2:03: Bipartisan Policy Center • 2:04-2:10: California Institute for Regenerative Medicine • 2:11-2:17: Coalition of Wound Care Manufacturers • 2:18-2:24: Curemonos • 2:25-2:31: Foundation for the Accreditation of Cellular Therapy • 2:32-2:38: International Society for Cellular Therapy • 2:39-2:45: National Center for Health Research • 2:46-2:52: Patients for Stem Cells 2:52-3:00: Questions from panel 3:00-3:30: Break 3:30-4:53: Session 5 • 3:30-3:36: The Amputee Coalition • 3:37-3:43: The Cord Blood Association • 3:44-3:50: The Cure Alliance • 3:51-3:57: Academy of Regenerative Practices • 3:58-4:04: Alliance for the Advancement of Cellular Therapies • 4:05-4:11: American Association of Neurological Surgeons and Congress of Neurological Surgeons • 4:12-4:18: American College of Surgeons • 4:19-4:25: American Society of Plastic Surgeons • 4:26-4:32: Biologic Orthopedic Society • 4:33-4:39: International Cellular Medicine Society • 4:40-4:46: International Federation for Adipose Therapeutics and Science • 4:47-4:53: The Plastic Surgery Foundation 4:53-5:00: Questions from panel 5:00-Close: Closing statement from Presiding Officer