FDA planning reorganization

FDA Commissioner Margaret Hamburg is reorganizing the agency's activities, but details on what is changing and what it means for FDA and companies likely won't become clear until later this year. Hamburg is adopting recommendations from a group of senior FDA officials -- including Janet Woodcock, director of the agency's Center for Drug Evaluation and Research (CDER) -- that she tasked last year with helping FDA adapt to changes in the regulatory environment, including globalization and new legal authorities and user fee programs.

According to an internal FDA memo, Hamburg agreed to organize FDA's regulatory and compliance activities around "commodity-based and vertically-integrated" regulatory programs, which the memo notes would include "pharmaceutical quality" and "medical devices and radiological health" as "commodity" categories. Hamburg also agreed that FDA inspectors and compliance officers should become more specialized in a particular regulatory program area. ...