FDA opens a new era of mandatory enforcement of regenerative medicine therapy and stricter supervision is coming...

Suppliers of unapproved cell-derived therapeutic products will find that the US FDA is about to terminate enforcement of these regenerative medicine products at its discretion, and start a new period of enforcement.

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

Now, Peter Marks, director of the FDA's Center for Biological Products Review and Research (CBER), said that the time is up and there will be no further delays.

“The improper advertising of these unapproved products in various media and the number of complaints about them submitted by consumers to the FDA are numerous.

Since December 2019, CBER has issued more than 350 warning letters and notices to manufacturers, clinics and individual doctors who "may provide unapproved regenerative medicine products.

In other warning letters during the COVID-19 pandemic, the FDA also pointed out that its risk-based enforcement approach means that regenerative medicine therapies designed to prevent or treat COVID-19 are more likely to attract the attention of CBER, including intravenous or intrathecal administration.

The Industry Association (ARM), which represents regenerative medicine companies, appreciates Marks' speech and the end of the era of law enforcement discretion.

Author: Zhilin-Acorn