Wednesday, June 04, 2008

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.

No comments: