Thursday, February 07, 2008

FDA’s Search for a Drug Chief Not Going Well: An Internal Candidate Emerges

We know all of you have been passing the time following the Presidential Primaries when the race you’re really interested in is who the next head of FDA’s drug center will be, right? Right.

A number of agency watchers and former officials agree that the longer the search goes on, the more likely FDA will be forced to look inside for a replacement. We talked to one former high-ranking FDA official with some knowledge of the search and here are some of the things we found out.

First, FDA Commissioner Andrew von Eschenbach is “concerned” that the recruitment for a director of the agency’s Center for Drug Evaluation & Research is taking so long and “not looking fruitful.” FDA chief medical officer Janet Woodcock is temporarily overseeing the center’s day-to-day operations until a permanent replacement is named. The absence of a CDER director has been magnified by the vacant director position at the Center for Food Safety and Applied Nutrition.

“He didn’t want the two largest centers without permanent leaders for a long time,” the former official says.

That’s why von Eschenbach made filling the CFSAN vacancy a priority. On January 4, FDA announced Center for Veterinary Medicine director Steven Sundloff would take over the food center.

There’s been some serious difficulty getting a large number of qualified external candidates, the ex-FDAer maintains, since the October 2007 departure of former CDER director Steve Galson due to his appointment as acting US Surgeon General. That’s understandable, according to the individual: “Who’d want a job when you won't know who your boss will be a few months out, where public perception is on the down slope, there’s little likelihood of getting substantial new appropriations, and you won't even be allowed to say you need more resources.”

That’s a convincing argument against wanting the job, wouldn’t you agree? When the search began in October 2007, an outsider taking over the drug center appeared to be a slam dunk. But now, as the French would say, c’est pas tout a fait evident. (Note: Washington Redskins fans are a little more cultured than the Eagles fans who occasionally write for this blog. We speak multiple languages, go to art museums, climb mountains…oh and we win Super Bowls.)

It appears that a serious internal candidate has, in fact, emerged.

We don’t know who it is, but we can speculate can’t we? Sure we can.

1) Center for Biologics Evaluation & Research Director Jesse Goodman:

As we noted in our earlier CDER search story, Goodman was the only FDA insider garnering serious consideration for the job at the outset. Goodman, a virologist, was named CBER director at the end of 2002, replacing Kathy Zoon, who moved to the National Cancer Institute.

The CBER head came to FDA in 1998, originally in the Office of the Commissioner directing the US Interagency Task Force on Antimicrobial Resistance. He later moved to CBER, where he worked on bioterrorism preparedness and blood and vaccine safety, eventually becoming deputy director before taking over for Zoon.

Most importantly for Goodman’s chances, he’s shown that he can run a large center within the agency’s organizational structure that operates in a similar fashion to CDER.

Odds: 3 to 1

2) CDER Deputy Director Douglas Throckmorton:

Time and time again, when the CDER search is brought up to FDA observers and former agency officials, I hear: “Why not Throckmorton?” Well, why not? Throckmorton would appear to be the obvious choice considering he has been the center’s number two for the last two and a half years. He served in an acting capacity for a year prior to that.

Before his promotion to deputy director, Throckmorton headed up the cardio-renal drugs division—a very high profile review group within FDA.

He also serves as chair of FDA’s Drug Safety Oversight Board, CDER’s liaison to the agency’s human subjects’ research review board, and chair of the center’s research coordinating committee.

Throckmorton has been involved in some interesting FDA meetings as of late. On January 9, “acting for” Woodcock, Throckmorton made a presentation to students and faculty at Duke University’s Fuqua School of Business along with Office of Medical Policy director Robert Temple. We know, we know, not the strongest evidence that he’s next, but still.

On January 17, the CDER deputy was involved in a senior CDER management meeting with PhRMA board representatives, including soon-to-be-retired Eli Lilly CEO Sidney Taurel, Lilly VP-global regulatory affairs, and PhRMA deputy VP for scientific and regulatory affairs Alan Goldhammer.

Meetings aside, Throckmorton has been viewed as somewhat of a rising star at FDA. He joined the cardio-renal drugs group in 1997 as a medical reviewer. Three years later, he was named deputy director of the division, and director two years after that.

So what’s the problem? One theory is that Throckmorton is too young. That seems a bit dubious considering all of his current responsibilities and fast rise up the career ladder. But if FDA were going to name Throckmorton as Galson’s replacement, they would have done it by now. After all, they passed on giving him the “acting” title altogether in favor of Woodcock, who previously ran the drug center.

Despite initially getting passed over, I still think he’s a very strong candidate and running right behind Goodman.

Odds: 5 to 1

3) Office of New Drugs Director John Jenkins:

Okay, we admit we are a bit in the tank for Jenkins. He recently took the time to speak at length with The RPM Report about the state of new drug approvals (aka the drug approval drought), drug safety, and the new drug reform regulations under the FDA Amendments Act. You can read it here if you haven’t already.

Before the interview, we thought Jenkins was a smart thinker and effective spokesman on regulatory issues. We are more convinced than ever afterwards.

Jenkins’ position alone as FDA’s top drug reviewer is enough for him to warrant consideration. He oversees 17 drug divisions and a number of important office-level groups within CDER. To see them all, click here.

You could argue that Jenkins’ ability to keep drug review times in check—actually reducing priority and standard review times in 2006—while reviewers are spread increasingly thin under a climate of poor morale makes him the most prepared to take over the drug center.

Case in point, FDA/Sponsor meetings have more than doubled over the last five years and Jenkins has calculated in the past that drug reviewers have nine industry meetings every working day of the year. In addition, new drug applications have increased in the 10% range while FDA’s budget has remained flat.

Publicly, Jenkins has been even more impressive. During a June House Oversight & Government Reform Committee hearing looking into the handling of heart risks linked to Avandia, Jenkins performed admirably before a host of Congressional lawmakers looking for blood.

He was equally impressive during a media briefing on January 25 to discuss how FDA planned on handling data from Schering-Plough/Merck’s ENHANCE study on the statin Vytorin. Click here to read our take on FDA’s response to questions about the Zocor/Zetia combination.

Jenkins is also an FDA veteran with 16 years under his belt, six as the head of the Office of New Drugs, and considered to be one of Woodcock’s “people.” One thing that could preclude him from getting the job is that the whole Vioxx debacle occurred while he was in charge of OND. But if that’s the case, none of the internal candidates listed here stand a chance of getting the CDER job.

Odds: 7 to 1

4) Office of Medical Policy Deputy Director Rachel Behrman:

Ah, the Dark Horse. There’s always a dark horse candidate. When you flip through the obvious internal candidates, Behrman doesn’t come to mind. However, one former FDA official says Behrman could be the most serious internal candidate.

Behrman was picked by Woodcock to head the Office of Critical Path Initiatives in the Commissioner's Office--an important priority for the agency in general and Woodcock in particular. That is in addition to her role as second-in-command to the dean of drug development Robert Temple in the medical policy office. And in her spare time, Behrman also serves as Director of the Cross-Centers Initiatives Task Force. That’s just the kind of collaborative position FDA Commissioner Andrew von Eschenbach has tried to promote within the agency.

Behrman joined FDA in 1989 and has some experience in the spotlight that the CDER director operates under. For instance, she testified before the Senate Special Committee on Aging regarding in 2005 regarding the impact of direct-to-consumer advertising on seniors. The full testimony is right here. The fact that the Division for Drug Marketing and Communication reports into the Office of Medical Policy probably serves as an advantage as DTC continues to remain a public and political focus.

Behrman’s obvious drawback as a candidate is that she has less direct experience with product reviews than the other candidates. Of course, if FDA's first choice would be an outsider, that drawback could actually be a selling point to the search committee.

Odds: 15 to 1

Place your bets.

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