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Tuesday, November 11, 2008

FDA Commissioner: Myths And Reality

Everyone wants to know who the next FDA commissioner will be, and we certainly have done more than our share to stoke speculation about the answer to that question. And we expect to do more of the same in the weeks and months ahead.

But before the frenzy gets entirely out of hand, we would like to offer a few rules of thumb about the commissioner search process.

(1) FDA May Be Your Top Priority, But It’s Not Obama’s

Just because the pharmaceutical industry considers FDA one of the most important positions in a new Administration doesn’t mean the transition team sees it that way.

In this climate, priority goes to economic posts (where the Securities & Exchange Commission is a more critical regulatory agency than FDA) and to Defense/National Security.

Even when the US is not at war or facing a financial crisis, FDA typically is way down the list of posts to fill. The Centers for Medicare & Medicaid Services usually is filled first, for example; with so much money under management by CMS it almost has to be.

And, in this Administration, when attention turns to health care appointments, the focus will be on health care reform teams as much as on agency appointments.

During the last transition, the first political appointment to FDA didn’t come until August, when Dan Troy was named chief counsel. As a Senate-confirmed post, commissioner takes longer—and in 2001 it took until nearly the end of 2002. Everyone hopes that long a delay can be avoided this time, but even with haste, there is unlikely to be a commissioner confirmed and on the job much earlier than 12 months from now.
(2) It’s Not Necessarily Obama’s Pick Anyway
There’s always some give-and-take between the White House staff and the new Health & Human Services secretary when it comes to filling the FDA post, and without knowing for sure who the HHS secretary is—and whether he or she sees FDA as a critical priority—there is no way to handicap that dynamic effectively.

And then there is the Kennedy factor. Historically, Ted Kennedy, the long-time chairman of the Senate Health Committee, has played a pivotal role in the commissioner selection process, holding veto power over any Republican selections and playing an even more direct role in the pick during Democratic Administrations.

However, Kennedy’s health may not allow him to play that role in 2009; if he steps down, his successor (potentially Maryland’s Barbara Mikulski) will certainly want some say in the process. But there may be a stronger voice for House members like Henry Waxman, whose staff has worked closely with the Obama campaign.

So no one can say for sure who will be involved in making the pick—which makes it hard to say who the pick might be.

So let’s face it: at this point, there’s a good chance the nominee will be someone no one has mentioned yet. Remember: Mark McClellan wasn’t even considered for FDA until after he’d already been nominated and confirmed for a different post in the Bush Administration.
(3) It Won’t Be An Insider
The biopharma industry would be thrilled if Center for Drug Evaluation & Research Director Janet Woodcock ends up as commissioner. Heck, the biopharma industry would be thrilled if she were President.

Don’t get your hopes up.

FDA is too plum a post to give to a career civil servant. There are too many people to reward and too few rewards to dole out to allow for that.

Even if the Obama team decided FDA is in such a state of crisis that they have to turn to an insider, the fact that Woodcock is so widely seen as industry’s top choice (like here) probably rules her out. Remember: the Bush Administration couldn’t get an “industry” pick at FDA. Why would an Obama Administration even want to try?

Woodcock could end up with the job nevertheless—but only if the outside choice (and maybe several outside choices) doesn’t make it through the Senate. And, as pleased as industry would be to have Woodcock running FDA, the prolonged uncertainty it would take before she really had a chance to get the job would be tough on the agency—exactly the outcome that industry wants to avoid in backing her for the post in the first place.
(4) It Might Be Nissen
Just as the perception that Woodcock is industry’s top choice isn’t going to help her get the job, the widespread suggestion that the Cleveland Clinic’s Steve Nissen would be the worst for industry doesn’t hurt him.

We have no idea if Nissen will end up at FDA—but as an Obama advisor he has already been vetted in case he is picked for some kind of government post. Maybe there is something in his background that rules him out, or maybe Obama, his HHS secretary, Kennedy, Waxman or someone else will want to go in a different direction.

But this we know: the opposition of industry won’t be the thing that keeps him out of the job.
(5) Nissen Might Not be so Bad After All
There’s no question that Nissen is unpopular with some in industry (like anyone who ever had anything to do with marketing Avandia or Vytorin).

But there are at least three reasons why industry might not be so bad off if he ends up at FDA.
First, as commissioner, Nissen can’t just lob grenades as products the way he has been in recent years. Sure, he might pull Avandia outright, rather than cripple it commercially—but as commissioner he also has to set some constructive public health agenda that doesn’t simply involve taking potshots at individual products.

Second, Nissen is not a drug safety gadfly at heart. Believe it or not, he wants to see industry succeed at developing innovative products. After all, he does drug development himself, and has spoken out in favor of products like Lilly’s prasugrel. As commissioner, you can bet Nissen would work just as hard to encourage the types of products and studies he likes as he would to discourage those he doesn’t.

Last but not least, there is the Kessler Effect: the last time a commissioner was appointed who defined himself by making enemies in industry, he also gave the agency the credibility it needed to establish accelerated approval and the user fee program. Kessler was never popular with industry, and drug companies celebrated his departure. But drug approvals have been in steady decline ever since. Coincidence or not, those were the good old days.

So happy speculating. Say, where is David Kessler anyway?…

1 comment:

John Mack said...

I invite all readers of In Vivo Blog to vote for the NEW FDA Commissioner!

Vote online here: http://tinyurl.com/5flc3r

After completing the survey, you will be able to see a summary of the results (de-identified to protect respondents anonymity).

Your comments are confidential (anonymous).

For more information, see: http://tinyurl.com/6aer9h