Policy-ish

FDA's Hamburg Talks Tough

When you become FDA commissioner, one of your first jobs is to lay down the law for all the companies, legitimate and otherwise, that make the food, drugs, devices and other health-related products consumed by Americans.

Industry: FDA Commissioner Hamburg is watching you.

Industry: FDA Commissioner Hamburg is watching you. Getty Images hide caption

itoggle caption Getty Images

Margaret Hamburg, confirmed in May as the 21st head of the agency, mapped out the FDA's role as beat cop in a speech Thursday to a lot of lawyers who represent those firms.

She sounded pretty tough to us. Her prepared text featured the words "enforce" or "enforcement" 39 times.

Most of the details probably aren't that interesting except to legal beagles, but Hamburg talked about setting clearer standards for companies and faster timetables for action that the public may even be able to keep tabs on. Watch the video, if you want the nitty-gritty, including some Q&A.

A new wrinkle: FDA will being posting updates on its Web site when companies have remedied problems serious enough to warrant a warning letter from the agency. "I hope that receiving a 'close-out' letter quickly becomes a top industry priority," Hamburg said.

The Commish also had some tough love for FDA workers. After praising the career staff a couple of times early on, she made clear she wants things to happen faster at HQ.

In her first months on the job, Hamburg said she discovered, the time it takes the agency to do "certain things—things that are just routinely accepted—sort of boggle the mind of someone coming in from the outside."

She seemed unwilling to tolerate the status quo, saying her own "naivete" might help speed up the process. "Frankly, some of these time frames don't seem acceptable to me," she said.

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