The FDA is disappointed with the slow progress in the application of stem cell therapy and will strengthen law enforcement against the sale of unapproved products

Wilson Bryan, director of the U.
S.
FDA Center for Biologics Evaluation and Research (CBER) Organization and Office of Advanced Therapeutic Products (OTAT), stated at a meeting hosted by the Food and Drug Law Institute (FDLI) on June 8 that the FDA is The slow progress of companies selling stem cell therapies in the city is "concerned", and therefore, enforcement efforts are being strengthened against companies that manufacture unapproved stem cell therapies
.

Bryan said, “We have always been very concerned about the high number of cell therapies, especially stem cell therapies that are “used for a wide range of indications but have no evidence of safety and effectiveness” sold to patients.
“Almost no company has sold its products before Seek regulatory approval"
.

He said that because of this delay, "we will have to continue to increase our law enforcement operations

When the FDA announced its regenerative medicine policy framework in November 2017, it began a three-year period of enforcement discretion
.

At the same time, two guidelines were issued explaining the criteria for determining whether devices, drugs or biological products derived from stem cells should be approved by the FDA

[FDA announced a comprehensive regenerative medicine policy framework 2017/11/18]

Bryan said that for the manufacturers of these products, the period of law enforcement discretion is now over
.

Except in limited circumstances, manufacturers who sell stem cell therapies must seek FDA approval

[FDA has opened a new period of mandatory enforcement for regenerative medicine therapy, and stricter supervision is coming? 2021/04/27】

Bryan also tried to clarify a misunderstanding that people generally think that law enforcement discretion makes it legal to sell unapproved products
.

He said that law enforcement discretion "means that we will not enforce the law, or we will enforce the law in a more relaxed way

Bryan stated that during the law enforcement discretion, CBER sent approximately 400 letters to manufacturers and medical institutions that may provide stem cells or related products that violate the regulations
.

There are also two enforcement actions against injunctions against manufacturers of violating products; the FDA has successfully obtained permanent injunctions against these companies

Bryan said that products that are particularly worrying are those that are used for orthopedic indications and injected into joints to relieve pain
.

"These products are very popular, and we believe that these products need to provide safety and effectiveness data