Tuesday, March 11, 2008

If You Want a Job Done Right....

Well, this is a bit of a surprise.

After a lengthy search for a permanent head of FDA’s Center for Drugs Evaluation & Research, the agency is turning the reins over to an old hand—Janet Woodcock.

We admit it: like most of Washington, we didn’t see this one coming. While we wrote about the probability of a candidate emerging from inside FDA in last month’s issue of The RPM Report, we didn’t predict that Woodcock would be the final choice to head CDER.

But we take some comfort in the fact that no one else did either. For most folks in the policy world—including those on Capitol Hill—Woodcock’s return to CDER (she was director from 1994 to 2005) was a big surprise, and frankly, a bit of a head-scratcher.

After all, moving from the number-two spot at FDA to head the center for drugs could be seen as a demotion of sorts—especially since Woodcock was given a position in the commissioner’s office at a time when it was perceived that she might leave the agency altogether.

Rather than risk her leaving FDA altogether, Crawford gave Woodcock the title of deputy commissioner for operations and chief operating officer, and named Steven Galson to succeed her as CDER director. Under Andrew von Eschenbach, Woodcock became FDA's chief medical officer. But when Galson was tapped to be the acting Surgeon General, she stepped back in as acting head of CDER.

So if nothing else, relinquishing her commissioner office-level roles to become the permanent head of CDER frees up Woodcock's schedule a bit. According to FDA, the agency will be looking for someone to succeed her as deputy commissioner and chief medical officer. That may not be an easy task, given that the position of CMO was created precisely with her in mind after it was recommended by the Institute of Medicine in a review of the agency's drug safety programs.

So it comes as a bit of a shock that Woodcock is back in the director’s chair. But given that she was leading the CDER director search committee—and therefore ultimately picked herself as Galson’s successor—we assume she found enough good reasons to return.

Many point to a potential political advantage: as director of CDER, Woodcock will be well-positioned with the incoming Administration. Being outside the Office of the Commissioner will allow Woodcock to be viewed more as the career FDA official she is, rather than a political functionary of the outgoing Bush Administration.

But someone like Janet Woodcock doesn’t need to worry about playing politics to stay employable: there are plenty in industry and elsewhere who would welcome her with open arms—and a hefty pay raise. And people that know her well argue that she’s not the kind of person that would try to preserve her job at all costs.

Perhaps what Woodcock’s appointment really reflects is a commitment on her part to steer CDER through this time of transition. After all, there will be plenty of action in the drug center around the implementation of the FDA Amendments Act, a task Woodcock herself has acknowledged will be a unique and historical challenge.

Plus, she’ll be returning to CDER at a time when the future of the prescription drug user fee program is in question, so she’ll have an opportunity to fix the program that she first helped implement back in 1992. Indeed, the news that Office of New Drugs Director John Jenkins had given his medical reviewers the green light to slip a little on user fee deadlines may have helped push the CDER announcement along.

Plus—and let’s be frank here—given the resource and morale issues at CDER right now, who else would want that job? As one policy person we spoke to pointed out, there are only so many “buckets” of people that would even qualify.

FDA can’t bring in anyone that might appear to be conflicted, or risk the ire of Capitol Hill, so candidates with industry ties are out. That leaves either:

(1) academia. With CDER in such disarray, there are few academics with the management skills to steer the center through choppy waters; or

(2) current FDA officials. While CBER chief Jesse Goodman looked to be a solid pick to head the drugs center, Woodcock’s experience—and a thick skin that was on display at Rep. Rosa DeLauro’s appropriations hearing last month—ultimately helped make her the only viable choice.

For industry, this couldn’t be better news. Woodcock is well known by pharmaceutical and biotech manufacturers, and is certainly a familiar face to head CDER. While some critics question whether she is too cozy with industry, on the whole, she is seen outside the agency as a smart, honest and pragmatic leader.

The Pharmaceutical Research & Manufacturers of America issued a statement of strong support, noting her “willingness to work with diverse partners.” And one VP of global regulatory affairs, Amgen’s Paul Eisenberg, gave her a thumbs-up. When we asked him what type of person Woodcock should pick for CDER, he suggested that she should pick someone like herself. “She is really a leading driver for improvement of how FDA focuses on science and approvals," Eisenberg said.

Well, if the right prescription for FDA was to find someone just like Janet Woodcock to run CDER, then she certainly made the right choice.

1 comment:

Anonymous said...

From the inside, VonEschenbach wanted Woodcock out of the FDA completely, but politically just could not pull it off. Inside and outside, she has been more than a bit too cozy with industry. CEDR did not thrive under her leadership in the past and will not in the future. Change and leadership are critically needed and these will not come from within the FDA.