FDA Proposal Would Speed Up Enforcement Actions

Industry's time to respond to warning letters limited.

Published on: Aug 10, 2009

While, admitting that some Food and Drug Administration enforcement actions have been hampered by unreasonable delays, FDA Commissioner Margaret Hamburg has outlined her commitment to prevent harm to the American people through swift, aggressive, and effective enforcement of FDA laws and regulations. Hamburg made the announcement while addressing an industry group organized by the Food and Drug Law Institute.


Hamburg
's proposal would give regulated industry no more than 15 days to respond to a warning letter. At the same time warning letters would only be reviewed by the Office of Chief Counsel when significant legal issues are present. Follow-up on warning letters and other enforcement actions would be prioritized. Speed coordination with regulatory partners when public health is at risk; be prepared to take immediate action in response to public health risks; and develop and implement a formal warning letter "close-out" process when a firm has fully corrected violations.