While You Were...Making History

Kudos to Michael Phelps for making it eight straight gold medals and setting a new record for olympic bling in a single games. And don't forget Dara Torres, darling of middle-aged weekend warriors everywhere, proving she's still got the goods to medal against women--I use that term loosely--young enough to be her daughters. Outside of Beijing and South Ossetia, it was a slooow weekend for news. Here's a look at some of the stories you may have missed while you were plugged into your neglectomat.

• The Pink Sheet Daily reports today that the Center for Drug Evaluation and Research's ability to review applications for new drugs and biologics within the timelines specified by the Prescription Drug User Fee Act has slipped a bit, dropping from 90% to 80%. But the drop has nothing to do with summer and those slackers at the FDA. Pink Sheet Daily notes that CDER's performance is better than might have been expected given the center's chronic staffing problems and increased workload.

• Addicted to Roche/Genentech news? The East Bay Business Times reports that a Reuters survey of industry analysts predicts Roche will boost its offer for Genentech to $53 billion, or $107.50-a-share. As colleague Jessica Merrill at Pink Sheet Daily noted in a piece last week, that kind of price tag could prove troublesome for Roche, which might have to cut research budgets or worse in order to wring necessary financial efficiencies out of the deal. Want the inside scoop on the deal? Check out our FREE coverage here.

• Investor's Business Daily has a review of the business strategy of The Medicines Co., which has eschewed blockbusters for more modest selling $200- to $300-million-a-year sellers instead, including the anticoagulant Angiomax and the high blood pressure drug Cleviprex. If the approach sounds familiar, that's because it's taken straight out of the little league manual. Get enough little hits--aka singles--and you score more runs than your opponent and win the game.

• The WSJ reports that Phelps isn't the only one commanding attention in Beijing. J&J, the maker of athlete's foot cream for half a century, has helped rescue one of China's most precious archeological treasures--its terracotta warriors--from a damaging athlete's-foot-like fungus. By nursing one of China's national symbols back to health, J&J hopes to get "a lot of lverage" in China, Alex Valcke, a European J&J exec told the WSJ.

• Finally, the NYT reports on the potential deadly side-effects associated with methadone. Once used mainly in addiction treatment centers to replace heroin, methadone is a synthetic form of opium being given out by family doctors, osteopaths and nurse practitioners for throbbing backs, joint injuries and a host of other severe pains. The drug, which is cheap, long-lasting, and powerful, has helped millions. But because it is also abused by thrill seekers and badly prescribed by doctors unfamiliar with its risks, methadone is now the fastest growing cause of narcotic deaths.
  

(Photo courtesy of Flickr user guano through a creative commons license.)

CDER Hiring Frenzy: More Reviewers Means Faster Reviews

Anyone concerned about today’s troubled economy and their own future employment prospects should submit a job application to FDA’s Office of New Drugs. They’re hiring.

Indeed, OND is on a virtual hiring frenzy to bulk up long-understaffed review divisions. As we reported in an earlier blog post, the Center for Drugs Evaluation & Research will hire 663 employees—helped in large part by new money into FDA, as well as CDER director Janet Woodcock’s successful efforts to gain direct-hiring procedures from HHS.

Now, according to new information released by FDA to The RPM Report, CDER is nearly halfway through that hiring goal, having brought on 309 new employees so far this fiscal year (ending September 30). That's not an insignificant number for CDER to swallow: the center for drugs employed 2,252 individuals as of May 13.

But there’s good news for drug sponsors: at 108 employees, new hires into the Office of New Drugs have far outstripped any other CDER office. (That's to be expected, given that OND is the largest office in CDER, but it is still worth mentioning.) Plus, most of the hiring is within the divisions themselves, with few, if any, additions at the immediate office level. That means more division-level medical reviewers, and more time spent on new drug applications.

Some review divisions are benefiting from the hiring frenzy more than others, depending on the previous level of understaffing. Divisions with the most new hires are Gastroenterology Products, which has hired 16 employees so far this fiscal year, followed by Cardiovascular & Renal Products (9) and Neurology Products (8). All divisions, with the exception of Anti-Infective and Ophthalmology Products, has hired at least one new employee.

(For a handy chart with a division-by-division breakdown, click here. You can also access a summary breakdown of new hires across CDER by clicking here.)

While the hiring process itself is going quite well, CDER is also fighting attrition, as long-time FDA employees leave the agency, either for retirement or for more lucrative jobs in industry and academia. "We’re making progress, and we’re getting our head count up, but a miracle hasn’t occurred," Woodcock said in a recent interview with The RPM Report.

Indeed, several top-level FDA scientists have left for industry, including Robert Meyer, the former head of the Office of Drug Evaluation II, for Merck, and Mark Goldberger, the former director of the Office of Antimicrobial Products, for Abbott. Both departures came just weeks after the announcement that CDER director Steve Galson would be leaving to become surgeon general.

As USA Today reports in an article today, when companies siphon off FDA's most experienced scientists, they leave a leaner, less confident staff that is hesitant to approve new drugs. "What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely," Steve Brozak, an analyst with WBB Securities, told USA Today. "This cannot have any positive effect whatsoever."

We have a slightly more optimistic outlook: In addition to the new hires, two other recent developments will help improve the regulatory environment for drug sponsors: 1) Woodcock's return to CDER; and 2) FDA's new REMS authorities. It won't happen overnight, but like Woodcock says, it's slow and steady progress.

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.

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.

Vaccines: A Good News Story for FDA; Good for Goodman Too?

In the old days of Kremlin watching during the Cold War, analysts used to track who was standing next to Soviet bosses to get an idea of the sources of power and ideas.

There is a minor version of that game going on in the hierarchy at FDA as the agency prepares to find a new leader for its Center for Drug Evaluation and Research, the top manager in the regulatory group that controls the flow of new pharmaceuticals to the market--and, more and more, makes decisions on which products can remain on the market.

The job has been empty since last September. We have written about several of the likely candidates here. There appears to be an obvious incentive for the Bush Administration to try to get someone into that post before leaving office, to leave someone to take care of the remnants of the Bush FDA initiatives.

One hint of who might be rising in favor within FDA comes not from pictures of agency officials standing next to current Commissioner Andrew Von Eschenbach, but rather from what programs are getting the highest praise from FDA’s leadership.

From the rhetoric coming out of FDA now, the agency’s vaccine program is a good news story at a time when FDA is desperately looking for a way to show how it promotes the public health. As that program gets more attention, the star must be rising for the person in charge, Center for Biologics Evaluation and Research Jesse Goodman (pictured above).

Von Eschenbach gave what was billed to be a major address on the agency last Friday at the National Press Club in Washington, DC. That is the forum and audience that FDA commissioners in the past have used to speak forcefully to defend the agency in times of bad publicity.

We are not covering it until one week later. That says something about how stirring Von Eschenbach’s speech was on February 29.

Despite good intentions, Von Eschenbach appears destined to go down as one of most ineffectual public defenders of the agency in its history. Even during the bad days of the generic drug crisis in the late 1980’s, Frank Young was able to be more convincing about the agency’s ability to implement “Action Plans” to fix its processes.

To his credit, Von Eschenbach cannot be accused of over simplifying the challenges facing FDA or of relying on soundbites and glib reassurances. He is quite honest with the public that the agency continually faces a challenge of keeping up with advancing science and changing food, drug and device industries worldwide.

Von Eschenbach ended his NPC speech with the admonition: “All must understand that there never will be the end point—because the process of transformation, adaptation, and regeneration must be continuous and ever-evolving; that is the nature of the world in which we live.” True. It is just not the type of inspiring reassurance that the public wants about FDA now.

Still, the agency’s progressive and aggressive actions in the vaccine field drew the best rhetoric from the Press Club podium. Von Eschenbach mentioned the vaccine efforts nine times in a half-hour speech.

Here’s a sample of von Eschenbach’s praise for the agency’s role in bringing more manufacturers into the flu vaccine business in response to concerns about the next flu pandemic.

“Unlike three years ago, when we had only three licensed vaccine manufacturers of influenza vaccine licensed in the U.S., we now have six licensed firms. As a result, rather than a shortage that occurred a few years ago, this year we have excess capacity.”

And he noted that the agency has played a cooperative role with industry to get a H5N1 strain vaccine pre-approved. “In 2007, we licensed the first influenza vaccine against the H5N1 influenza virus.” He pointed to the step up in pandemic preparations as a sign that FDA can and “did change radically and rapidly with great benefit as a result.”

FDA would clearly like more tales of cooperation, with ample evidence of a clear benefit for society. If his rhetoric is a hint of where he thinks the agency’s success stories lie, look for Goodman to get more publicity and more responsibility.

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.