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On both coasts, campaigns are building to get desperate patients faster access to stem cell treatments — in some cases, before they are proven to work. And that is making some scientists nervous.
In Washington, a US senator recently introduced a bill that would allow the FDA to grant conditional approval to stem cell treatments without data from the big Phase 3 trials usually required before a drug hits the market. The bill has drawn the support of some stem cell companies, patient groups, and researchers, but a number of industry groups, scientists, and patient advocates have come out strongly in opposition.
Proponents say an accelerated regulatory process will help patients, but a chorus of critics warn that faster approvals could undermine the FDA’s authority to ensure that only rigorously tested therapies make it to market.
“There’s this misperception about why these trial requirements exist,” said Dr. Aaron Kesselheim, an expert on regulatory issues. “Clinicians need data to guide their decision-making, and patients want treatments that work.”
Read full, original post: Drive to get more patients experimental stem cell treatments stirs concerns