FDA commissioner: Agency to revamp enforcement system

ROCKVILLE, Md. With a new administration and a new commissioner, the Food and Drug Administration plans to step up enforcement.

FDA commissioner Margaret Hamburg announced Thursday a plan “to prevent harm to the American people” through “swift, aggressive and effective” enforcement of FDA laws and regulations. Hamburg said that some FDA enforcement actions over the past several years have been subject to delays, resulting in serious violations going unaddressed for long periods of time.

Under Hamburg’s plan, the agency will take six initial steps to change the agency’s enforcement system. These include clear deadlines for responding to FDA inspection findings; speeding up the warning letter process; working more closely with other regulatory agencies; prioritizing follow-up on enforcement actions; being prepared to take immediate action in response to public health risks; and developing a formal warning letter “close-out” process for when a company has corrected violations.

“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” Hamburg told attendees of a speech sponsored by the Food and Drug Law Institute in Washington. “WE must get the word out that the FDA is on the job.”