FDA at a Crossroads - Pharmaceutical Technology

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FDA at a Crossroads
Will more resources and new leadership fix FDA, or is a major overhaul in order?

Pharmaceutical Technology
Volume 33, Issue 1, pp. 32-40

Jill Wechsler
Last year was particularly tough for the US Food and Drug Administration. The international heparin crisis erupted just as the agency was digesting a scathing assessment of its capabilities from its advisory Science Board. That report outlined how a depleted work force, obsolete information-technology (IT) systems, and a weak science base prevented FDA from carrying out its mission.

The following months brought more contaminated food, drug-safety problems, a campaign against cough and cold medicines for children, and public airings of internal dissension. FDA recently drew additional fire over the discovery of melamine in baby formula and plastic containers that could harm infants. "FDA is barely hanging on by its fingertips," attorney Peter Barton Hutt told the House Energy and Commerce Committee in early 2008, 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 Alastair Wood in an April 2008 New England Journal of Medicine editorial. A leading critic is Rep. Rosa DeLauro (D-CT), who chairs the House Appropriations subcommittee that oversees FDA's budget. At an April 2008 meeting about "Science at FDA" sponsored by the Institute of Medicine, DeLauro asserted that FDA needs "urgent and dramatic reform" because it cannot perform basic functions such as keeping track of clinical trials, conducting required inspections, and following up on commitments for postmarket studies. DeLauro blames many of FDA's ills on manufacturers and has blocked funding for the new Reagan–Udall Foundation until its organizers ensure that it's "not just another tool for industry."

In Washington This Month
She also fears that FDA's Critical Path Initiative may persuade agency scientists that it's more important to develop methods to support product approval than to objectively evaluate safety and efficacy data. DeLauro, moreover, would like a three-year moratorium on direct-to-consumer advertising of newly approved drugs and added curbs on conflicts-of-interest among members of advisory committees.

A new administration and new FDA leadership will provide an opportunity for change. This is "a watershed time for FDA and the pharmaceutical industry," says 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 2008 meeting sponsored by the Generic Pharmaceutical Association. Woodcock's aims are 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."

Food fight

Achieving these goals may require broader changes in FDA's structure and operations to better fit the global world of pharmaceutical and food production. FDA is responsible for ensuring the safety and quality of about 80% of the US food supply, an activity that has suffered from insufficient resources and limited authority. Because the regulatory model for food is different from that for drugs and medical devices, DeLauro and others propose to transfer

FDA's responsibility for food regulation to a new federal agency. Such an entity would assume responsibility for multiple programs (e.g., meat and dairy inspections, import controls, and pesticide regulation) now spread among a dozen government offices. The Department of Health and Human Services has opposed such a move, claiming that food safety is primarily a public-health issue. But much of the food consumed in the US is now produced in foreign regions, and this shift has created a difficult situation for an overloaded public health agency to monitor.


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