FDA Turnaround Time

Jan 01, 2009

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."

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She even fears that FDA's Critical Path Initiative may send the message to agency scientists that it's more important to develop methods to support product approvals than to objectively evaluate safety and efficacy data. DeLauro would like a three-year moratorium on direct-to-consumer advertising of newly approved drugs and stiffer curbs on conflicts-of-interest for members of advisory committees.

Watershed Time

A new administration and new FDA leadership could provide an opportunity for change. This is a watershed moment for FDA and the pharmaceutical industry, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). The public is concerned about drug quality and imports, industry is struggling with a productivity crisis, and the global financial meltdown may dry up investment for biomedical innovation, she observed at a fall meeting sponsored by the Generic Pharmaceutical Association. Woodcock's aim is to restore public confidence in the drug regulatory process, capitalize on advances in science and technology, improve postmarket oversight, and make FDA "the recognized leader in drug regulation."

Efforts to achieve those goals will be shaped by FDA's next commissioner. Many names have been circulated for the position in the last month—a sign of the agency's high visibility and importance to the new administration and to Congress. There's considerable hope that FDA's new leader will be named and confirmed by the Senate in a few months, instead of languishing at the bottom of the White House appointments list.

FDA's leader needs management and leadership skills, and familiarity with FDA's mission is helpful, says former commissioner Mark McClellan, now at the Brookings Institution. "This is a complex agency," he notes, "And it can't be run by command-and-control, but by providing support for staff to do outstanding science-based work."

One priority for the new commissioner will be to justify continued growth in appropriated funds for the agency's 2010 budget. The Alliance for a Stronger FDA has called for a 20 percent increase in FDA appropriations, to $2.25 billion for next year. That's less than $400 million in new money —a drop in the bucket for most federal agencies.

FDA and industry also hope that with Democrats in control of both the White House and Congress, there will be fewer attacks on the agency from Capitol Hill. An effective commissioner can provide "a heat shield from criticism for the agency," says McClellan, adding that it's easier to get financial support when there's clarity about the direction FDA will take.

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