Janet Woodcock's move to become director of the Center for Drug Evaluation and Research illustrates the operational challenges FDA faces: The agency remains deeply 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, Woodcock is returning to CDER on a permanent basis. Woodcock, who was the agency's chief medical officer, had been filling in as acting CDER director since October, and she will now resume that role outright.

The appointment is a return to form for both Woodcock and the agency. Woodcock 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 Also see "PDUFA’s Fairy Godmother: Woodcock Steps Into Breach As Acting CDER Chief" - Pink Sheet, 1 October, 2007., p. 3).

At the time Woodcock stepped in, many observers expected that the new drug 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 deeply familiar with the center's culture who had helped create many of the review processes that 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 the helm at CDER, the heads of the other centers all have extensive experience at FDA. Within CDER itself, the agency elevated Gerald Dal Pan when it picked a permanent head for its safety office after an extensive search (² Also see "FDA Gets Permanent Drug Safety Director In Advance Of Drug Center Overhaul" - Pink Sheet, 24 October, 2005., p. 3).

An Agent Of Change

While Woodcock's appointment has the appearance of continuity, FDA Commissioner Andrew von Eschenbach emphatically denied that Woodcock was simply a placeholder for the agency, telling "The Pink Sheet" that 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."

"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 that FDA has already announced is the "Safety First" and "Safe Use" initiatives (³ Also see "Safety First: FDA Unveils New Postmarketing Management Process For Safety" - Pink Sheet, 3 March, 2008., p. 4).

At the same time, CDER is now letting user fee deadlines slip for application reviews, and Woodcock understands that a smoothly functioning review process is critical to the success of any broader undertakings (see ⁴ Also see "FDA Misses User Fee Goals As Resources Tighten For Application Reviews, SPAs" - Pink Sheet, 17 March, 2008.).

Woodcock assumes command of a center with a dramatically broader mission then the one she left: The FDA Amendments Act expanded the agency's powers to ask for additional data and impose labeling changes and risk management plans on products.

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 (⁵ Also see "What Does AERS Mean? FDA Takes A Close Look At Spontaneous Reporting" - Pink Sheet, 11 February, 2008., p. 31). 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 release announcing Woodcock's move noted that she would stay involved in Critical Path activities, but that only serves to emphasize that the energy FDA is putting into the project is necessarily limited.

FDA said it would be searching for a replacement as chief medical officer, but the vacancy there comes as FDA's science program comes under increasing public scrutiny. The agency's Science Board recently recommended splitting the role into two as part of an effort to boost FDA's research resources (⁶ Also see "FDA Should Look Through IIRIS To Improve Science, Panel Says; Funding Is Worry" - Pink Sheet, 10 December, 2007., p. 15). And FDAAA calls on the agency to create an "Office of Chief Scientist," a provision included over the objections of the administration (⁷ Also see "FDA Reform Bill Leaves Senate With Reduced Safety Powers But Stiffer Fines" - Pink Sheet, 14 May, 2007., p. 16).

A CDERiffic gal

Woodcock was a perfect fit for the role, but those attributes will obviously serve her at CDER as well. She has appeared tough with industry, but has the respect of companies and is comfortable with congressional oversight. At a hearing of the House Appropriations Agriculture Subcommittee last month, she defended the user fee system.

"It is absolutely not the case that FDA is excessively influenced by industry in its judgement 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."

Despite that relationship, after the announcement of her move to CDER, Pharmaceutical Research and Manufacturers of America President Billy Tauzin released a statement praising Woodcock and highlighting her work on the Critical Path.

Tauzin also said "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. Her 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."

Woodcock's skills, vision and broad support are critical as she implements FDAAA at CDER, but her success may still come down to resource mechanics largely out of her control. The center is essentially drowning in user fees, and needs 550 new hires to bob to the surface (⁸ Also see "FDA’s “Dysfunctional” Hiring System May Be Good For Safety Databases" - Pink Sheet, 3 March, 2008., p. 3).

- Becky Jungbauer (r.jungbauer@elsevier.com)

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

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