The enforcment action comes after years of scientists’ demands for agency to do more.
By William Wan and Laurie McGinley April 3 at 6:10 PM The Food and Drug Administration on Wednesday sent 20 letters to companies in the burgeoning stem cell industry, telling them they are selling an unapproved product in violation of federal laws.
For years scientists, doctors and consumer advocates have pressed FDA to move more aggressively against for-profit stem cell clinics. In the face of relative inaction by FDA, the industry expanded exponentially. Scientists believe stem cell research may lead to solutions to complex and intractable diseases. But scientific societies, medical associations and leading researchers have issued warnings against for-profit clinics, comparing them to modern snake oil salesmen.
“I do think warning letters have had a deterring effect,” Gottlieb said, adding that each warning letter requires immense FDA resources. “The unmistakable message is that the firms’ time to come into compliance is rapidly running out,” said Paul Knoefler, a stem cell biologist at the University of California at Davis and frequent critic of the for-profit stem cell industry. “It may be by the end of 2020 we’ll see fewer risky stem cell clinics out there than in 2019.”
In a public version of its warning letter sent to Cord for Life, FDA officials redacted the name of a third party copied on the letter. But the unredacted version shows Liveyon as the third party copied, according to someone who has seen the letter and requested anonymity to describe it.
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