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THE NEXT BATTLE IN THE STEM CELL WARS — A two-day meeting hosted by the FDA kicks off today to hear public comment on four draft guidances put out in 2014 outlining the agency’s approach to regulating stem cell therapies. The meeting, first scheduled for one day in April on FDA’s campus, was delayed, expanded to two days and moved to an NIH auditorium to accommodate a tidal wave of requests for participation. The FDA has proposed some limited exemption from regulation for a narrow range of stem cell treatments — part of what is outlined in the guidances. But it is generally maintaining its traditional standards of safety and efficacy for more complex applications — the use of adipose stem cells to repair retinas, for instance. Many prominent scientists, entrepreneurs and stem cell trade associations, agree with the FDA’s approach. But others want a more lax standard: grant a preliminary approval once studies show a treatment is safe — meaning it could be marketed and used by patients while data is collected to establish whether it actually works.
… That’s the thrust of Sen. Mark Kirk’s REGROW Act, which he has been pushing this year, setting off alarm bells inside FDA and among consumer advocates, who worry about unleashing a wave of unproven treatments on patients seeking cures. For years, people have traveled to unregulated clinics in other countries for stem cell treatments. A report earlier this summer found that such clinics have also proliferated in the United States, with more than 351 companies in 570 locations. REGROW advocates say a lighter touch by FDA could help weed out bad actors while enabling small companies to get in the market and advance the science. But many experts say lowering the bar for stem cell treatments could badly tarnish a promising field of research if dangerous therapies are allowed to be sold. And there are many stories of the dangers. Here’s one. ICYMI, Brett’s story on REGROW. Note: Kirk policy hand Andrew Vogt said in an email that Kirk’s office would not be attending the FDA meeting. […]
… At a preliminary meeting on the science of stem cell treatments last week at FDA, Stanford’s Irving Weissman, a prominent stem cell researcher, said that the best way forward for the field would be “the triumvirate” of strong FDA requirements to prove the efficacy of treatments, revoking the medical licenses of providers who participate in unregulated, unproven trials and strong penalties against false advertising.
… Diana Zuckerman, president of the National Center for Health Research told Prescription PULSE that “it’s only the cowboys who want to do their own thing without anyone looking over their shoulder.”
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