The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved.
Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for that, especially from stem cell clinics. For instance, I am publicly opposed to the REGROW Act, a piece of legislation that would dangerously weaken oversight of experimental stem cell therapies. Still, I have not yet seen a statement from major stem cell organizations on these issues. It was therefore a great boost to hear just now that the top stem cell biotech industry organization, The Alliance for Regenerative Medicine (ARM), has issued a statement firmly opposing the REGROW Act.
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. For more background on these pushes for stem cell deregulation, please see my past posts on the Bipartisan Policy Commission (BPC) report that proposed extreme measures such as conditional approval of experimental stem cell interventions, charging patients to be experimented upon, and eliminating Phase III trials in some cases and also see my post opposing the REGROW Act.
It is a big, positive decision for ARM to oppose the REGROW Act, and I’m encouraged to see that I’m not alone in opposing this overreaching legislation. The reasons for ARM’s opposition and my own rationales for being against the bill substantially overlap. We both focus on the dangers posed to patients by inappropriately extreme deregulation. I can’t speak for ARM, but my impression is that they like many of us support some changes in how stem cell therapies are regulated. Perhaps there is hope that the REGROW Act could reemerge in a new incarnation in the future that is more balanced and would chart a prudent path forward.
I’ve pasted ARM’s statement on the REGROW Act below:
“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.
Note that ARM leaders Michael Werner and Edward Lanphier seem to be the point people on the REGROW issue.