Monday, March 17, 2008

FDA's Janet Woodcock: "Change Agent"

FDA Commissioner Andrew von Eschenbach expressed rare public irritability last week at the American Enterprise Institute.

What brought an edge to the voice of the usually unflappable, on-message commissioner? He bristled at the suggestion that the re-appointment of Janet Woodcock to head of the Center for Drug Evaluation & Research represents an attempt to rebuild the old ways of running the agency’s drug regulatory operations.

“I do not see her going back to CDER as business as usual,” von Eschenbach shot back in response to a question from a reporter during a Q&A session. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.”

Just because she has a long tenure in FDA management and is can be termed an “insider”, the commissioner said, “does not in any way, shape or form mean that she is not a change agent.”

For those that know the commissioner well, von Eschenbach’s sharp response came as a bit of a surprise. He generally maintains an unflappable demeanor and absorbs immense criticism for the agency and his management team without flinching. His restraint, in fact, is probably one of the factors in the constant beating on the agency in the media and on Capitol Hill.

So why get so irked about questions about the Woodcock appointment?

One answer is that von Eschenbach is worried that the staff within FDA is misinterpreting the appointment.

He says, in fact, that he has been “emphatic” within FDA in explaining his view of an active role for Woodcock at CDER. “The CDER that Dr. Woodcock will create for tomorrow is nothing like the CDER that she left,” he told the AEI forum.

Woodcock offers “understanding of the historical perspective as well as the external realities that are now impacting upon the agency,” the commissioner says (see here). She is “absolutely, the most extraordinarily gifted and talented person to lead” change at CDER, the commissioner told AEI.

Another reason for von Eschenbach’s pique is the lack of understanding from the outside world to the importance that he is putting on his end-of-term appointments at the agency. At this point on the down slope of his tenure at FDA, von Eschenbach appears to be viewing his recruitments and appointments to on-going agency management as one of his key lasting legacies for the agency.

The Woodcock appointment is “not the only appointment that has occurred and will occur at FDA; there will be others,” he declared. We have pointed out elsewhere the signs of stress and management holes within CDER (see here). FDA has a lot of mid-level and senior management positions to fill that will determine the character and focus of the agency through the next topside transition in early 2009.

Von Eschenbach stressed the need to “look at it in the totality of the kind of changes that are occurring both in staffing and in organizational structure and in the programs that we are implementing. In the totality of that, you will see the transformation that we are attempting to achieve.”

From the view of a lasting transformation, the Woodcock appointment is very savvy. She has identified herself in a court deposition as being a Democrat by political affiliation, but has clearly bought into one of the goals of the Bush Administration for FDA: to make the agency aware of changes that it can make to improve the drug development process–lumped for short-hand purposes under the sobriquet of the “Critical Path Initiative.”

By moving Woodcock off the commissioner’s staff to a line management position, von Eschenbach also opens up the possibility of recruiting someone for that deputy commissioner, chief medical officer position. If he can find someone to accept that position who has the credentials and political neutrality to survive a changeover of administrations, von Eschenbach may have a bigger role in shaping the post-election FDA.

Ex-FDA Commissioner Mark McClellan pointed out the key role for the chief medical office in a separate presentation at the AEI meeting. This is the job that was highlighted by the Institute of Medicine drug safety committee that reviewed and suggested structural changes needed at FDA in 2006. The position appeared to be designed for Woodcock, but now offers von Eschenbach a chance to find someone (probably from academia) who can try to survive the post-election changes.

McClellan told AEI that the deputy commissioner position could be a key slot for determining policy in the future. “The way you get the most done in the agency is to create a framework that enables people to get together and understand the weight of the scientific issues and get some scientific momentum behind the concepts and directions in which you want to take the agency,” McClellan said.

“Maybe the deputy commissioner for science at the agency…could bring together center directors and make sure that this gets built in consistently to what is going on in the agency.” McClellan said that driving policy at FDA takes a very hands-on consensus-building approach. It is like being a university president, he said. It cannot be achieved by “top-down directives.”

Instead, the management requires convincing “many people that are knowledgeable and pride themselves on being up-to-date on at least their particular area of expertise.” The commissioner cannot be expected to manage that process personally, McClellan suggested. The commissioner will have to rely on the next tier appointments–positions that von Eschenbach now has a chance to fill.

There is at least one other possibility why the commissioner reacted strongly at the AEI meeting: the question hit an exposed nerve. He senses that Woodcock will be challenged by FDA’s critics as a lame-duck appointment who will not have a significant impact.

And that view of FDA exists among knowledgeable people watching the agency. Former FDA Commissioner David Kessler was also at the AEI meeting. He sat silently, and unacknowledged, at the back of the room during the first day when von Eschenbach spoke. But on the second day, he quite pointedly spoke out from the dais about the state of leadership at the agency.

“I am interested in who is responsible for the leadership” on policy issues at FDA, Kessler declared. From practical experience, he suggested that the line operating heads at the agency cannot take time to deal with overall policy. “The center divisions have a lot on their plates,” he noted.

That leaves the challenge for guiding policy directly on the shoulders of the commissioner and his top staff. When does the commissioner's office get involved, Kessler asked. “Who is in charge on these broader policy questions? They are complex, they need to be driven. It is not just the day-to-day that you are dealing with.”

Maybe that is why von Eschenbach dropped his calm exterior for a moment. He knows that he is viewed as letting the agency float through a critical period. He is trying to assemble the right team for another FDA commissioner in the future, to try to influence a period even less under his control. That is a tricky and thankless task–one where a little anger is understandable.

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