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What ails the FDA

October 19, 2006

A GUILTY PLEA FROM FORMER FDA Commissioner Lester M. Crawford shows that the ethics guardians are making some progress against conflicts of interest at the Food and Drug Administration. Now they need to delve deeper into ethical lapses at the agency, which has been suffering a crisis of confidence.

Crawford, who resigned as commissioner a little more than a year ago, pleaded guilty Tuesday to lying to investigators about stock he owned in companies that were regulated by the FDA. Yet, according to one study, more than a fourth of the experts who sit on the FDA's advisory panels, which review the safety and effectiveness of drugs, have potential economic stakes in drugs they consider.

Other independent reports have found that regulators often ignored safety experts and refused to move against drugs that showed signs of serious side effects. That's one reason Vioxx, despite its heart risks, remained on pharmacy shelves long after it should have been pulled. Political pressure also has weighed on the agency, which dithered about approving over-the-counter sales of Plan B, the morning-after contraceptive pill, despite its positive ratings from agency scientists.

Current legislation to make drug evaluators and safety experts work together more closely, and to give the safety side more autonomy, would take the agency one step forward. But Congress should take the opportunity to impose more comprehensive reforms next year when it reconsiders the user fees that provide much of the FDA's funding.

Reforms will require striking a sensible balance between the need for expertise and tolerance for conflict. The agency needs specialists well versed in the substances it regulates, but such people often gain their expertise by working or consulting for drug companies. One way to mitigate such conflicts of interest is to require disclosure -- and recusal when there is a meaningful conflict.

The FDA also has suffered from both a literal and metaphorical lack of leadership, spending most of the last two years under acting and interim commissioners. The current acting commissioner, Texas surgeon Andrew C. von Eschenbach, is a solid replacement for Crawford. He deserves to be confirmed by Congress so that the FDA can turn its full attention to regaining the public's confidence and protecting its health.

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