“I want to send kudos to ARM and its more than 250 members.
For years in this debate there was a bright line between the academics as well as mainstream organizations in the stem cell arena (together supporting the need for rigorous science-based stem cell medicine and for the FDA, even if some reforms are needed) versus the dubious stem cell clinics out to make a quick buck and wanting as little regulation as possible.
However, in the past year we’ve seen a troubling seismic shift such that some academics and others who used to support the FDA have begun arguing for dramatically less regulation of experimental stem cell treatments.”
“My understanding is that the dubious stem cell clinic lobbying force is happy with the REGROW bill as it would shift the regulatory framework toward their philosophy even if they don’t get everything they want. REGROW proponents want to rocket forward with stem cells into patients by eliminating Phase III trials and establishing a risky conditional approval paradigm. I haven’t seen any evidence that Phase III clinical trials for stem cells are unnecessary nor that the conditional approval paradigm would be safe.
The Alliance for Regenerative Medicine (ARM) has issued a statement firmly opposing the REGROW act.
ARM Statement in Response to U.S. Senator Kirk’s REGROW Act – March/April 2016:
The Alliance for Regenerative Medicine is appreciative of Senator Kirk’s longtime support of the regenerative medicine sector and his belief in the transformative durable treatments and potential cures this field holds for patients. Our organization is committed to our continued cooperation with Senator Kirk and his staff to advance policies supportive of this sector and expediting potentially life-saving cell therapies, gene therapies and other regenerative medicine products.
However, ARM cannot support the REGROW Act. We continue to believe the proposal does not contain critical statutory protections for patients. We look forward to a continuing dialogue with the sponsors of REGROW Act as well as other stakeholders to create alternative approaches to ensure access to safe and effective regenerative medicine therapies without putting patients at risk, disadvantaging American therapeutic developers and potentially damaging a very promising field of medicine.