FDA's New Enforcement Approach Will Put More Warning Letters In The Mail

Full article reprinted from "The Gray Sheet" - August 10, 2009

FDA Commissioner Margaret Hamburg is honing the agency's enforcement system to get warning letters out faster and create a formal "close-out" process that publicly indicates when a firm has addressed FDA's concerns. Read more...

FDA's New Enforcement Approach Will Put More Warning Letters In The Mail 

Full article reprinted from "The Gray Sheet" - August 10, 2009

FDA Commissioner Margaret Hamburg is honing the agency's enforcement system to get warning letters out faster and create a formal "close-out" process that publicly indicates when a firm has addressed FDA's concerns.

Hamburg outlined six immediate steps FDA will take to improve its enforcement efforts at an Aug. 6 Food and Drug Law Institute meeting in Washington, D.C.

With the formal close-out procedure, once FDA determines that a company has fully corrected violations raised in the warning letter - usually based on a follow-up inspection - it will send a close-out letter to the company and post the information on its Web site.

"I hope that receiving a close-out letter quickly becomes the top industry priority," Hamburg said at the FDLI meeting, billing it as "an effort to work with industry to support and foster a rapid recovery when they've done the right thing."

FDA hopes to begin the process with letters issued from Sept. 1 onward.

Hamburg also announced that FDA will limit the number of warning letters that are reviewed by the Office of Chief Counsel to those that raise significant legal issues, which will get warning letters out the door faster.

- Jessica Bylander

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