Much to the surprise of most close observers of the Food and Drug Administration, Janet Woodcock agreed last month to resume control of the Center for Drug Evaluation and Research. She headed CDER for ten years before moving up to be deputy commissioner and, more recently, FDA chief medical officer. But when CDER director Steven Galson left last year, Woodcock shifted back as temporary CDER chief. And now, after a long search for a replacement, she has decided to take on the job herself.
Woodcock returns as head of CDER at a difficult time for the organization. A main task is to implement the myriad provisions of the FDA Amendments Act (FDAAA), which involves writing new rules and multiple guidances as well as expanding programs and operations on many fronts. The good news is that CDER has added resources to hire some 700 additional staffers; the bad news is that the hiring and training process will consume considerable time and energy.
Pharmaceutical companies applauded the move, much relieved to see a well-known and highly regarded old hand take the reins. Woodcock demonstrated that she has the political skills necessary to deal with a highly belligerent Congress in responding to sharp questioning a few weeks ago from the House Appropriations subcommittee that oversees FDA’s budget. Woodcock is sure to have many more experiences of the sort, as the legislators probe FDA’s funding needs, oversight of clinical trials, field inspection system as well as drug and food safety monitoring. While agency critics continue to question FDA’s ability to keep harmful medical products off the market, patient advocates and their allies press for faster access to life-saving therapies. Heading CDER right now is a tough job, and FDA is lucky to have Woodcock willing to take it on.