The FDA is ramping up enforcement activities against companies developing unapproved stem cell therapies, particularly for spine and orthopedic indications, according to the Regulatory Affairs Professional Society.
Few companies have sought regulatory approval for stem cell therapies before marketing, with a high number of products being marketed to patients without "evidence of safety and effectiveness," Wilson Bryan, MD, director of the FDA's Office of Tissues and Advanced Therapies, part of the Center for Biologics Evaluation and Research, said at a June 8 meeting.
Dr. Bryan said that the FDA's three-year period of enforcement discretion is now over for developers of stem cell therapies. Companies marketing these products must seek regulatory approval, except for limited circumstances, according to the report.
During the enforcement discretion period, the Center for Biologics Evaluation and Research sent 400 letters to manufacturers and providers who may be offering violative stem cell or related therapies.
The FDA recently obtained permanent injunctions against stem cell clinics in Florida and California that marketed unapproved stem cell treatments.