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Monday, January 12, 2009

The Panetta Formula

What does CIA have to do with the FDA? Not much (we hope) in the normal course of business.

But as the interest and speculation builds about the selection of the next FDA commissioner, there may be a relationship.

President-elect Obama’s selection of Leon Panetta to head the CIA is the connection. Not the man, but the nature of the choice. The CIA selection demonstrates how the Obama team is resolving appointments where there is a clash between key constituency groups. The Obama solution: find an experienced government manager above the fray.

FDA obviously doesn’t have the profile of the CIA appointment; but the position is well-recognized in government circles as one that deserves careful attention. FDA can make a lot of decisions and get embroiled in a lot of health and safety issues that quickly bubble up and catch an administration unawares.

High among the qualities that the new administration is looking for at FDA is strong leadership from a new commissioner. That was one of four qualities cited by HHS-secretary designate Tom Daschle at his January 8 confirmation hearing before Sen. Ted Kennedy’s Health, Education, Labor and Pensions. The new head will make sure that FDA decisions come from evidence and effectiveness, not ideology, Daschle said. The former Senate Majority Leader said that the agency needs strong policy, resources up to par, and coordination.

The administration appears to be looking for someone at FDA who can be sold to the public as being a strong advocate of public health, science and safety – without raising the threat of being an inexperienced crusader (“no impassioned amateurs need apply” - as one advocate for the agency says).

If the search follows that pattern, then the formula for a successful candidate will be an image of experience and unimpeachable public service credentials in someone who can be firm without being controversial. That could negatively affect two of the leading candidates: Cleveland Clinic cardiologist Steve Nissen and Baltimore City Health Commissioner Joshua Sharfstein. That will quietly please some pharma companies that have the limited goal behind the scenes in the selection of trying to make sure that anybody but these candidates gets the top FDA post.

We have been on a soapbox for nearly two years that the agency needs a fresh, forceful leader who will be perceived as tough on industry but at the same time will re-open the door for a period of increased drug development. That sounds paradoxical on the surface, but the tough regulator who is interested in drug development has occurred in the past and could be good for the industry and society. It would be a share if the new administration took the term drug safety and changed that to mean a safe and stolid agency as a way to avert the risk of headline actions.

If FDA experience and gravitas dominate the search, that does lead back to one former tough regulator and drug development advocate: former FDA Commissioner David Kessler. But he was controversial as commissioner, particularly with Republicans on Capitol Hill who faulted him as a turncoat for ostensibly changing his tone at FDA from his time as an aide to Sen. Hatch and for attacking tobacco with a vehemence. He may have a hard time shaking that reputation. He could draw more fire in a confirmation hearing than the FDA position is worth to the new administration.

We have noted previously the recent rise in speculation for another former commissioner, Jane Henney. Her name is re-emerging in a number of general press stories on the post. Henney was never controversial but also may have difficulty filling the role of the strong leader. FDA did approve RU-486 under her tenure and that may be enough to create the image of the leader focused on science and not ideology.

The interest in Henney highlights that there is a lobby to get a woman back at the head of the agency. Here is where another tie between CIA and FDA comes to light: the time for a little FDA-inology (like Kremlinology).From photo analysis and rhetoric reading worthy of the 1960’s, one potential candidate for the position gets a boost -- George Washington University’s Susan Wood. Look back at some of the early Hillary Clinton rallies and you can see Wood standing right next to Maryland Democrat Senator Barbara Mikulski. Similarly, listen to Mikulski at the HELP Daschle hearing. Mikluski is a key figure in the choice for an FDA commissioner: she views FDA as a local constituency.

From Mikulski’s point of view, Wood’s departure from a top staff position at the agency over the delay of Plan B was a sign of the inappropriate politicization of the agency. Wood’s resignation from the agency in 2005 fixed her permanently in the minds of some influential Capitol Hill figures as the emblem of integrity and public spirit that define strong leadership -- maybe that will be enough to earn her the strong, knowledgeable but non-controversial mantle that may be emerging as the formula for FDA.

2 comments:

James said...

If FDA experience and gravitas dominate the search, that does lead back to one former tough regulator and drug development advocate: former FDA Commissioner David Kessler. But he was controversial as commissioner, particularly with Republicans on Capitol Hill who faulted him as a turncoat for ostensibly changing his tone at FDA from his time as an aide to Sen. Hatch and for attacking tobacco with a vehemence. He may have a hard time shaking that reputation. He could draw more fire in a confirmation hearing than the FDA position is worth to the new administration.

Anonymous said...

Given her role as a board member of both pharma and the insurer Cigna, there may also be problems if Henney is nominated b/c if her Forbes bio is correct, she is on the boards of both pharma and the health insurer Cigna.