Stem cell clinics get a reprieve from FDA oversight
Back in 2017, amid a rash of frightening injuries and questionable marketing, the FDA gave unregulated stem cell clinics three years to start behaving like proper drug companies. Now, with that deadline approaching, the agency is giving those clinics an extension.
As STAT’s Andrew Joseph reports, the new rules were meant to take effect in November, but the FDA has pushed them back until May 2021 “as a result of the challenges presented by the Covid-19 public health emergency.”
The issue relates to rapidly proliferating clinics that offer unproven and potentially unsafe stem cell treatments. Because of a loophole in federal law, those clinics aren’t bound by the rules that require drug developers to run clinical trials that are tightly regulated by the government. Once the change takes effect, stem cell clinics will have to undergo the same scrutiny required of companies developing pharmaceutical products.
Read more.
As STAT’s Andrew Joseph reports, the new rules were meant to take effect in November, but the FDA has pushed them back until May 2021 “as a result of the challenges presented by the Covid-19 public health emergency.”
The issue relates to rapidly proliferating clinics that offer unproven and potentially unsafe stem cell treatments. Because of a loophole in federal law, those clinics aren’t bound by the rules that require drug developers to run clinical trials that are tightly regulated by the government. Once the change takes effect, stem cell clinics will have to undergo the same scrutiny required of companies developing pharmaceutical products.
Read more.
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