FDA Turnaround Time

Jill Wechsler
First, there was the international heparin crisis. Then more contaminated food, a crackdown on cough-and-cold medicines for children, melamine in baby formula, and multiple drug safety issues. The Science Board said that FDA cannot do its job due to a depleted work force, obsolete information systems, and a weak science base.

"FDA is barely hanging on by its fingertips," attorney Peter Barton Hutt told Congress a year ago, leading the chorus seeking increased resources for the beleaguered agency.

Since the Vioxx debacle four years ago, FDA's credibility has crumbled, opening the door for Congress and the media to play "kick the FDA," commented professor Alastair Wood in a New England Journal of Medicine editorial last April. A leading critic is Rep. Rosa DeLauro (D-CT), who chairs the House Appropriations subcommittee that oversees FDA's budget. At an Institute of Medicine meeting in April, DeLauro asserted that FDA needs "urgent and dramatic reform" because it cannot perform basic functions, such as tracking clinical trials, conducting required inspections, and following up on postmarket study commitments.

DeLauro blames many of FDA's ills on Big Pharma, and has blocked funding for the Reagan-Udall Foundation until its organizers ensure that it's "not just another tool for industry."