Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss

Janet Woodcock's move to become director of the Center for Drug Evaluation and Research illustrates the operational challenges FDA faces: The agency remains committed to its historic bargain with the drug industry to take user fees in order to improve application review, but it is finding it increasingly hard to meet deadlines or to perform any other outside projects.

After two years in the FDA Commissioner's office as chief medical officer, Woodcock is returning to CDER on a permanent basis. She had been filling in as acting CDER director since October.

The appointment is a return to form for both Woodcock and the agency. She served as CDER director for over a decade, moving to the commissioner's office in 2005.

She was replaced by Steve Galson, whose appointment as acting U.S. Surgeon General last fall created the vacancy that Woodcock has been filling on a temporary basis (¹ 'The Tan Sheet' Dec. 10, 2007, In Brief).

When Woodcock became acting CDER director, many observers expected the new center's next chief would be an FDA outsider, someone who would be seen as unscarred by the deep rifts between the application review and safety oversight segments of the center.

But at the end of the six-month search, the best candidate was one who was deeply familiar with CDER's culture and had helped create many of the review processes it uses today.

The decision follows FDA's routine practice of identifying leaders from within the agency. While Galson was a relative outsider when he took CDER's helm, the heads of the other centers all have extensive experience at FDA.

An Agent Of Change

While Woodcock's appointment may appear as an effort toward continuity, FDA Commissioner Andrew von Eschenbach emphatically denied that she was simply a placeholder for the agency, saying she would be an agent of change.

"First of all, I want it absolutely clear in everyone's mind - and I'm very emphatic about this even within the agency - people have said, 'Oh, Dr Woodcock's going back to CDER.' That's absolutely not true. The CDER that Dr. Woodcock will create for tomorrow is nothing like the CDER that she left. I do not see her going back to CDER, business as usual, but going back as a very, very strong change agent," the commissioner said.

"We have mapped and discussed many of those changes that she is embarking upon. So, the fact that she's an 'insider' does not in any shape, way or form mean she's not a change agent, but in fact has the benefit of really understanding the historical perspective as well as the external realities that are now impacting the agency, and by virtue of that is absolutely the most extraordinarily gifted and talented person to lead that change," von Eschenbach said.

The agency "did a very extensive national search and had many, many very talented candidates. I also will tell you that it's not the only appointment that has occurred or will occur at FDA. There will be others. I hope you'll look at it in totality, the kind of changes that are occurring both in staffing and organizational structure and the programs that we're implementing. And in the totality of that, see the transformation that we're attempting to achieve."

One step forward, FDA has already announced is the Safety First and Safe Use initiatives (² (Also see "FDA “Safety First” Initiative, Agency’s Requests Draw Doubts From DeLauro" - Pink Sheet, 3 Mar, 2008.), p. 9).

At the same time, CDER is now letting user fee deadlines slip for application reviews, and Woodcock understands a smoothly functioning review process is critical to the success of any broader undertakings.

Woodcock assumes command of a center with a dramatically broader mission than the one she left: The FDA Amendments Act expended the agency's powers to ask for additional data and impose labeling changes and risk management plans on products (³ (Also see "FDA Reauthorization Steers Clear Of Agency’s OTC Authority, DSHEA, AER Law" - Pink Sheet, 24 Sep, 2007.), p. 3).

Along with the new powers came a boost in user fees and a charge to create an active surveillance network to help detect and analyze adverse events. That new technology holds the promise to allow FDA and industry to calibrate their safety activities much more accurately, but the project also illustrates the agency's dilemma in moving Woodcock to CDER.

While the top spot at CDER is now full, FDA is without a top medical officer, a critical role as the agency hopes to create transformative drug development and surveillance systems.

The announcement of Woodcock's move noted she would stay involved in Critical Path activities, but that only emphasizes the energy FDA is putting into the project is necessarily limited.

FDA said it will search for a replacement as chief medical officer, but the vacancy there comes as FDA's science program comes under increasing scrutiny. The agency's Science Board has recommended splitting the role into two as part of an effort to boost research resources (⁴ (Also see "Advisors Say FDA Funding Fails Science, Senators Pan Food Safety Plan" - Pink Sheet, 17 Dec, 2007.), p. 10).

Further, FDAAA calls on the agency to create an "Office of Chief Scientist," a provision included over the objections of the administration.

The Industry's Perspective

Woodcock's leadership "comes at a time when Congress has granted FDA's drug center new authorities, bolstered appropriations, combined with enhanced user fees paid by America's pharmaceutical research companies," Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America says in a release.

"Her stable guidance will be particularly important to an agency that is striving to implement groundbreaking reforms to better position itself to tackle future challenges," Tauzin adds in the release.

Indeed, she defended her user fee system at a hearing of the House Appropriations Agriculture Subcommittee last month.

"It is absolutely not the case that FDA is excessively influenced by industry in its judgment about drugs," she said.

"Our staff has an adversarial relationship with industry and it always has. It goes up and down over the years, probably in an up phase right now," she added.

- Becky Jungbauer ([email protected])