The FDA Alliance tirelessly pushes for more money for the Food and Drug Administration, and generally I am supportive. The agency was starved for funds for most of the Bush administration and an adjustment was in order.

But as I pointed out last week, passage of the FDA Amendments Act in 2007 started the rejuvenation process, which is now well underway. Non-user fee employment at the agency grew from 7,116 pre-FDAAA to 9,413 last year. In the budget announced by President Obama yesterday, that total would grow to only 9,689 in 2011, assuming Congress passes the 6 percent or $146 million budgetary increase requested by the president.

In its press release, the 180-member FDA Alliance expressed disapointment in a budget jump that exceeded most other agencies on the discretionary spending list. "The FDA needs a real increase if it is to establish needed new programs and hire new people to carry them out," said Wayne Pines, president of the Alliance.

Why do I think a one-year cooling-off period makes sense? First, the projected growth in user fees from tobacco regulation will push total employment at FDA from 12,335 to 13,586, which constitutes another substantial jump. I know from informal discussions with FDA staffers that the agency is scrambling to train the hundreds of new employees it has added in the past few years. In the coming year, top managers at the agency who oversee the new employee absorption process will have to devote their attention to starting up this whole new area of regulation. 

In addition, the pace of new drug development remains at a comparatively  low level. While this is a user-fee generating activity and thus doesn't affect the general budget, it suggests that ancillary support staff will not be facing inordinate new pressures. Meanwhile, the FDA has earmarked $25 million in new funds to upgrade regulatory science at the agency to cope with genomics, personalized medicine and new methods for evaluating clinical trial evidence.

Take the two together -- the ongoing slowdown in drug development and its changing technological base -- and it suggests to me that the frontburner personnel issue for the agency, at least its drug and biologics divisions, should be retraining current staff as much as training new employees. 

Indeed, many of the new tools created by FDAAA are still months if not years away from being available for both new and veteran employees. The FDA recently awarded a 4-year, $72 million contract to Harvard Pilgrim to compile 50 million patient records in its "mini-Sentinel" system, which will allow FDA personnel to search for safety signals after drugs hit the market (the full system by law is supposed to incorporate 100 million patient records). At a conference I attended a few weeks ago, Richard Platt of Harvard, who will run the system, said its architects were still many months away from having it be ready for use by FDA epidemiologists and safety surveillance experts.

And then there's the larger question of properly managing new employees and having proper operating systems that will allow them to be effective. The FDA's most visible failings of the past decade -- Vioxx, Chinese heparin, food poisoning outbreaks -- were a product of structural failings at the agency as much as they were caused by a shortage of personnel.

For instance, the Center for Drug Evaluation and Research had all the information it needed to question the safety of Vioxx before 2004. All it required was managers willing to pay attention to their own staffers, or to articles in the medical literature that warned about the drug's dangers as early as 2001.

Something similar could be said about the nation's food safety system, which clearly needs thousands of new people to insure that food imported from abroad -- an increasing share of our food supply -- is sanitary. But without a revamped reporting and tracking system, those new people could wind up with salmonella-ed egg on their collective faces the next time a foodborne illness breaks out.

But that's the direction that appears to have been taken by the administration. This morning's Washington Post described the requested budget increase for the agency this way:

A large chunk of the additional funds would be spent on food safety, which has been flagged by Obama as a domestic priority. The FDA is reorganizing the way it monitors the production of food, with plans to step up inspections of domestic and foreign food suppliers, expand its laboratory capacity, and improve its ability to trace the source of an outbreak of food illness, among other things.

The bottom line is more resources and a better monitoring system (with Congressional help) for food, and more training but fewer new employees for drugs and biologics. The administration's budget request priorities gets it just about right.