Hamburg: Flexible Enforcement Is an FDA Priority

The FDA is pursuing more flexible enforcement mechanisms to handle situations such as the recent contamination of GlaxoSmithKline’s pediatric Rotarix vaccine, Commissioner Margaret Hamburg says.

Creative enforcement may involve taking an action that some stakeholders do not see as an explicit FDA authority, Hamburg said at the 2010 Food and Drug Law Institute Annual Conference.

FDA Chief Counsel Ralph Tyler pointed out that just because Congress has not said explicitly that the FDA may ask physicians to stop using a vaccine does not mean that the commissioner is without power to do so.
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