WASHINGTON (AP) — A whole lot of clinics pushing unproven stem cell procedures caught an enormous break from the U.S. authorities in 2017: They might have three years to indicate that their questionable remedies had been secure and labored earlier than regulators began cracking down.
However when the Meals and Drug Administration’s grace interval expired in late Could — prolonged six months because of the pandemic — the results turned clear: A whole lot extra clinics had been promoting the unapproved remedies for arthritis, Alzheimer’s, COVID-19 and lots of different situations.
“It backfired,” says Leigh Turner, a bioethicist on the College of California, Irvine. “The size of the issue is vastly bigger for FDA right now than it was at first.”
The persevering with unfold of for-profit clinics selling stem cells and different so-called “regenerative” therapies — together with concentrated blood merchandise — illustrates how rapidly experimental medication can outpace