Gupta in for Galson: What's Next for Former FDAer?

Anyone looking at the FDA public calendar this week (who doesn’t love to keep track of the comings and goings of government officials?) may have noticed something peculiar: Steven Galson, the former director of the Center for Drugs, was listed as an FDA participant in a recent meeting at the agency.

According to FDA’s website, Galson joined FDA commissioner Andrew von Eschenbach and Center for Drug Evaluation & Research director Janet Woodcock at a “meet and greet” with the University of Florida officials at FDA’s Silver Spring headquarters on December 17. Galson and Woodcock are listed as “other FDA participants.”

There are a lot of changes expected in FDA leadership in the next few weeks, but Steve Galson’s return to the agency was not one of them. So naturally, we were a bit curious. Could Galson, who left CDER in October 2007 to become acting US Surgeon General, be returning to FDA? Or did the agency’s webmaster err in including him on the calendar?

We reached out to Galson to ask him to explain. It turns out he was invited to participate in the closure of an agreement between FDA and the University of Florida on a new fellowship program. That program, which is designed to bring fresh blood into FDA, is a pet project of von Eschenbach’s and one that his principle deputy commissioner, Frank Torti, has been overseeing since joining FDA last summer.

Galson was invited not in his capacity of a former FDA official (despite what the public calendar says), but because the Florida deal involves officers in the Public Health Service, and as acting Surgeon General, Galson is the Commander of the Commissioned Corps. (He’s also a Rear Admiral.)

But that doesn’t necessarily mean that a return to FDA isn’t in the cards. Galson is expecting to be out of a job in the next few months: according to the Washington Post, President-elect Barack Obama has offered the Surgeon General position to prominent neurosurgeon and television talking head Sanjay Gupta.

Galson is a career government official—not a presidential appointee—so he's not expected to be immediately asked leave the Surgeon General’s office once Obama takes office. But with Gupta as the apparent pick as his successor, it looks like Galson will be looking for another job in the next few months. So what’s next for the former FDA official?

Galson says “is not ruling out any possibilities”—including a potential return to FDA. His next move, Galson says, will depend on how certain appointments come out (presumably the FDA commissioner spot), but he's “looking at all options.”

We’re sure Galson has lots of options—in addition to FDA, he has held senior-level positions at the Environmental Protection Agency (as head of the Office of Science Coordination & Policy) and Department of Energy (as chief medical officer) and worked earlier in his career at the Center for Disease Control and Prevention.

But Galson did join FDA specifically to help the agency revamp its postmarketing surveillance program. That was in 2001, and the agency is still revamping its postmarketing surveillance program. We're just speculating here, but maybe that “meet and greet” at FDA will be the start of Galson's next career move.

The Long Campaign for FDA Commissioner (Part 2)

Yesterday, we told you about Steve Nissen's presentation during the FDA/CMS Summit for Biopharma Executives.

He wasn't the only speaker at the conference whose name has been mentioned as possible commissioner material. The opening keynote, for instance, was by Janet Woodcock, the head of the Center for Drug Evaluation & Research and the hands-down first choice of biopharma executives to be the next commissioner.

That is the first reason why she almost certainly won't get the job. As we wrote previously, industry support is definitely not something the Obama team is likely to weigh too highly when it gets around to making the pick. Nor is it likely that the new administration will pass up the opportunity to give the plum post to an outsider it would like to reward, rather than to a career FDAer, even one as abundantly qualified as Woodcock.

Indeed, the day before Woodcock spoke at the Summit, Rep. Bart Stupak (the chair of one of the Congressional committees that oversees FDA) wrote to the President-elect to declare that no agency insiders should be considered for the post even on an interim basis. Stupak, as "The Pink Sheet" reports, wants "a complete change in FDA's leadership."

Stupak, as it happens, chose the losing side in an internal Democratic party fight over leadership of the Energy & Commerce Committee, so his opinion may not carry as much weight as it once would have. But we're betting that the transition team won't be looking to antagonize Stupak unduly by nominating Woodcock for the job.

As for giving her the post on an interim basis, not only would that antagonize Stupak, but it would probably do exactly the opposite of what her supporters want: if Woodcock is the acting commissioner, she would almost certainly leave the agency once a Senate confirmed commissioner comes on board.

So who will the next FDA commissioner be?

We're betting that the closing speaker at the Summit, FDA deputy commissioner Frank Torti, will end up claiming that title--albeit only on an acting or interim basis. That, at least, is what the natural order of things would dictate, a fact that has been clear since Torti joined the agency six months ago.

And after that? Well, that's what campaigns are for.

Stay tuned: On Monday we'll bring you Part 3 of our campaign-for-commish series.

FDA's Internal Advisory Committee Meetings

Avandia. Vioxx. Ketek. Elidel. Palladone.

What do those drugs have in common? The obvious answer is that they are all associated with a major safety problem that resulted in a significant FDA regulatory action—either a “black box” warning in product labeling, or, in the case of Palladone and Vioxx, outright removal from the market.

But they have something else in common as well. In the months preceding those major regulatory steps, each product was the subject of a relatively unknown internal meeting at the Food & Drug Administration: a regulatory briefing.

Regulatory briefings can be described as “internal advisory committees” at FDA—a chance for review divisions to ask others in CDER for advice on how to handle a tricky regulatory or scientific decision. (For more on regulatory briefings, check out our coverage in The RPM Report. If you’re not a subscriber, you can sign up for a free trial to view the article.)

If you’ve never heard of a regulatory briefing, you’re not alone. Regulatory briefings have been kicking around FDA’s Center for Drug Evaluation & Research for more than a decade, but because they are closed to industry—and review divisions don’t always inform sponsors when one is held—many companies are unaware that they exist. But now FDA is holding more of them, as many as one per week. And they are quite popular with reviewers.

The good news for drug sponsors is that regulatory briefings are not intended to be decisional meetings; the final approvability decision remains with the review division after the meeting is over. But given the typical attendance list—John Jenkins, Janet Woodcock, Bob Temple, Doug Throckmorton and 50-100 other drug reviewers—it would be hard to ignore any advice.

A drug does not have to rise to the level of an Avandia or a Vioxx to be discussed during a regulatory briefing—given the frequency of such meetings, that could not possibly be the case. But, as the list above indicates, they do tend to skew toward the more problematic end of the continuum. The need for a regulatory briefings should not spell doom and gloom for a sponsor, but it could be an indication that something is wrong. That alone makes them worth watching.

image via FDA

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.

Janet Woodcock’s To Do List For CDER

Given that Janet Woodcock has been back at the Center for Drug Evaluation & Research for six months now (with two months as permanent director), we figured it was high time to check in and see what she’s been up to.

The answer? Quite a bit.

As Woodcock told The RPM Report in an interview, she's the kind of person that likes to get things done. So upon returning to CDER last October, Woodcock settled on two immediate objectives:

(1) Gaining direct hire procedures from HHS’ Office of Personnel Management.

(2) Dedicating more attention on post-marketing safety.

Check and check.

As a result of Woodcock’s efforts, FDA just won direct-hiring procedures from HHS and has since embarked on a major hiring initiative to staff up its scientific ranks. CDER alone will hire 663 employees—444 new positions and 219 in backfill. The hiring frenzy will eventually help end the “lean years” at FDA, when the agency's regulatory mandate outstripped its available resources.

On post-marketing safety, Woodcock launched the “Safety First” initiative last October, putting post-marketing drug safety on par with new drug approvals. As part of that multidisciplinary, team-based approach, the Office of Surveillance & Epidemiology is now an “equal partner” with the Office of New Drugs. Remember those public fights over Avandia and Ketek? Woodcock hopes that "Safety First" will put those to rest.

Of course, there are still challenges ahead. CDER needs to train all those new hires, and the Center is still feeling its way on the “Safety First” initiative and implementation of the FDA Amendments Act in general.

And then there’s the issue of those new risk evaluation and mitigation strategies, or REMS, which have Woodcock weighing in on new drug applications more than usual. For more on that, as well as the status of drug approvals under her stewardship, click here. If you're not already a subscriber to The RPM Report, you can sign up for a free trial to view the article.

The Heat is On...The Hill

It may be springtime in Washington, but things just keep heating up for FDA and the pharmaceutical industry on Capitol Hill.

Heparin safety, the overseas inspections process, DTC advertising, FDA's budget and the integrity of the agency's scientific mission have all been the subject of one or more hearings so far this year.

Indeed, one influential member of Congress alone—Energy & Commerce Oversight & Investigations subcommittee chairman Bart Stupak—has already held four hearings related to pharmaceutical regulation. That doesn’t count his hearing today on DTC advertising and a crowded schedule in 2007, which included a two-part series on drug safety and a four-part series on food safety.

Center for New Drug Evaluation & Research director Janet Woodcock has shouldered more than her fair share of that hearing burden, testifying several times already this year, most recently on the heparin crisis and drug safety in general. She acknowledges the stress of the schedule she’s been keeping on Capitol Hill, but hopes that her testimony has helped put some issues to rest.

“We’ve had a good show for ourselves, at least at CDER,” she says. “We can get criticized, but I think we have answered the criticism, and that’s what we need to keep pressing on.”

One positive outcome may be more money for FDA: Sen. Ted Kennedy (D-Mass.) supports increasing FDA's fiscal 2009 appropriations by $375 million over FY 2008, with larger increases for the next five years. Commissioner Andrew von Eschenbach may have dampened enthusiasm for that big of an increase, however, by telling the Senate Appropriations Committee April 15 that FDA could absorb an additional $100 million in funding in FY 2009.

But the attention isn't all upside: We’ve said it before, but when FDA officials are hauled up to Capitol Hill and bashed over the head for doing a poor job, that doesn’t reflect too kindly on the industries it regulates. Woodcock expressed hope that the attention will start to shift to other issues. “They will continue to have oversight hearings,” she said, but “Congress will become more interested in the electoral process very soon.”

Well, not quite yet. FDA isn’t appearing at Rep. Stupak’s hearing on DTC advertising—executives from Pfizer, Merck/Schering Plough and Ortho Biotech are testifying today. But that doesn't mean they won't be next. We hate to say it, but this is exactly the kind of attention that we (ahem) predicted would happen following the Vytorin/Zetia kerfluffle. Given Rep. Stupak’s preference to hold multiple hearings on a single topic, you can bet it won’t be the last word.

The Other FDA Drug Chief

The drug industry is breathing a sigh of relief now that Janet Woodcock has permanently assumed the role as head of FDA's drug center.

But let's say Woodcock had turned down returning to oversee the Center for Drug Evaluation and Research, who would have been Commissioner Andrew von Eschenbach's next choice? Well, you can take a look at my incredibly accurate odds-making piece I wrote a few months ago. There were a number of internal candidates who may have been the choice. To read it, click here.

However, if von Eschenbach had decided to look outside, there were a number of names being thrown around as candidates. Two that I've mentioned before are Cornell pharmacologist Marcus Reidenberg and former University of Utah cardiologist Jeffrey Anderson. You can read a little more about them in The RPM Report by clicking here (registration required for non-subscribers).

Recently, I learned that another outside candidate was being pushed heavily by former FDA officials: Indiana University pharmacologist David Flockhart.

Flockhart appears to be exactly the type of candidate the agency would have been looking for in an external contender. Flockhart, chief of the division of clinical pharmacology at Indiana, is a believer in the personalized medicine revolution and the basic tenets behind FDA's Critical Path Initiative. To read more about his points of view on medicine, science, genetic testing and drug safety, click here.

A former Georgetown University researcher, Flockhart is credited with establishing Indiana as a site for NIH/National Institute of General Medical Sciences’ Pharmacogenetics Research Network. He received his MD from the University of Miami School of Medicine and PhD from the Welsh National School of Medicine in Cardiff.

So why does this matter? Well, it's interesting, isn't it? But more importantly, these are the types of thought leaders to keep on your radar for later down the road in different administrations or as possible liaisons between FDA and the academic world for key FDA/NIH/CMS initiatives. That's why they matter.

I'll keep my ear to the ground for other candidates that were interviewed or championed for the CDER director position so we can start a whole web series on "People Who Weren't Named CDER Director."

Finally, tune in next week for my Personalized Medicine Mailbag blog post. I wanted to thank everyone for the overwhelming response to my personalized medicine post. Apparently, people care about this issue. It's not too late to email me with your take on the personalized medicine vs. cost effectiveness debate.