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
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
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."
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.
In Washington This Month
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."
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.