F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics
WASHINGTON — The Food and Drug Administration announced a crackdown on dangerous stem cell clinics on Monday, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.
The agency reported actions against two large stem cell clinics and a biotech company, saying that it was critical to shut down “unscrupulous actors” in regenerative medicine, a broad umbrella that includes stem cell and gene therapies and immunotherapies.
“The F.D.A. will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” said Dr. Scott Gottlieb, the F.D.A. commissioner. [...]bioethics biotechnology fda human subjects research innovation medical safety pharmaceuticals regulation stem cells