US FDA's Drug Seizures Seen As Most Significant Aspect Of Stem Cell Crackdown

06 Sep 2017

Former Office of Compliance and Biologics Quality Deputy Director Mark Schwartz says dishonest players have not often seen serious enforcement actions from the agency.

Seizure of property. Yellow warning tapes with inscription "SEIZURE OF PROPERTY"

Stem cell manufacturers have rarely been subject to aggressive US FDA enforcement actions, but Commissioner Scott Gottlieb's recent announcement about a crackdown on unscrupulous companies in the regenerative medicine industry along with the seizure of product from a California facility could signal a meaningful change in how the agency targets dishonest industry players, a former FDAer says.

The Center for Biologics Evaluation and Research (CBER) has not often directed the seizure of unapproved product as it did...