US health agency to crack down on risky stem cell offerings
WASHINGTON — U.S. health authorities announced plans Thursday to crack down on doctors pushing stem cell procedures that pose the gravest risks to patients amid an effort to police a burgeoning medical field that previously has received little oversight.
The Food and Drug Administration laid out a strategy for regulating cell-based medicine, including hundreds of private clinics that have opened across the nation in the last decade. Many of the businesses promote stem cell injections for dozens of diseases including arthritis, multiple sclerosis and even Alzheimer’s. They can cost $5,000 to $50,000, but there’s little research that such procedures are safe or effective.
Researchers for years have called for a crackdown. FDA officials said they will focus their enforcement efforts on “bad actors” who inject stem cell mixtures into the bloodstream, nervous system or eyes. Regulators say those procedures pose the biggest risk to patients.
“We’re going to be prioritizing places where we see products — not just being promoted inappropriately — but putting patients at potential risk,” FDA Commissioner Scott Gottlieb told reporters on a conference call.