The FDA plans to crackdown on unsubstantiated and poor quality stem cell therapies in 2019, Law 360 reports.
"We'll be stepping up actions in this space in the coming months," said FDA Commissioner Scott Gottlieb, MD, at a Food and Drug Law Institute conference in Washington, D.C., Dec. 12. "You can all expect to see brisk activity from the FDA when it comes to some rogue stem cell outfits that are putting patients at risk."
At the conference, Dr. Gottlieb referenced lawsuits filed in May against stem cell clinics in Florida and California that marketed unapproved stem cell treatments. He also drew attention to the FDA's 2017 invitation for stem cell companies to have conversations with regulators about ensuring legal compliance, stating many companies have not yet responded. "Many of them will be hearing from us," he said.
Melissa Mendoza, the deputy director of the FDA's office of compliance and biologics quality, denounced companies for "aggressively promoting stem cell products for a wide range of serious and often life-threatening diseases" with little scientific basis. "There's more to come in this space, and soon, so be on the lookout," Ms. Mendoza said.