The US Food and Drug Administration badly needs some strong and stable leadership.
On 18 July, the US Senate finally confirmed Lester Crawford as commissioner of the Food and Drug Administration (FDA). Crawford has been acting commissioner since March 2004. This critically important agency has lacked a confirmed leader for more than half of President George W. Bush's tenure — and the cracks are beginning to show.
Crawford, a pharmacologist, veterinarian and member of the Institute of Medicine, has previously held senior positions at both the FDA and the Department of Agriculture. In 2002 and 2003 he was the FDA's deputy commissioner. Patient advocates praise him for trying to improve the predictability and efficiency of cancer-drug approvals. And he has expertise in food safety and animal health — relevant skills in an era of bioterrorism and bird flu.
On some issues, however, Crawford already stands accused of lacking the independence and leadership skills required of the position. One bone of contention, which held up his Senate confirmation for several months, concerns access to an emergency contraceptive. Despite the approval of a panel of outside scientific experts, as well as the FDA's own staff scientists, Crawford had failed to act on an application from the manufacturer to make the ‘morning after’ contraceptive known as Plan B available over-the-counter. This month, the agency finally promised to make a decision by 1 September. The troubling implication is that until his nomination got bogged down in the Senate, Crawford bent to political pressure from an anti-abortion White House, instead of making a decision based on the best scientific evidence, which concluded that Plan B is safe and effective.
Crawford also seemed to be caught flat-footed last autumn, when the UK authorities shut down a Chiron plant in Liverpool, halving at a stroke last winter's US supply of flu vaccine. The FDA had failed to re-examine the plant after it had contamination problems in 2003 — even after the company reported, two months before it was shut down last October, that millions of doses of flu vaccine had been contaminated.
Additionally, consumer advocates are worried by a recent sharp decline in FDA enforcement actions against false or misleading advertising. FDA warning letters to pharmaceutical companies fell by 70% between January 2002 and December 2004, at a time when drug companies were pouring unprecedented sums into advertising directly aimed at consumers. Crawford was the FDA's top manager for much of this period.
Now his position has been confirmed, Crawford has more leverage, and he should have plenty of opportunities to demonstrate the leadership that the agency requires. Another flu-vaccine shortage looms this winter, and bird flu threatens the prospect of a 1918-style pandemic. Public suspicion of the pharmaceutical industry continues to grow in the wake of the Vioxx withdrawal (see Business, Painkiller in the dock), amid evidence that drug-makers are still slow to file evidence about the safety of established products with the regulator. In the face of these challenges, Crawford has to prove that he is the right man for the job. He could start by doing the right thing by Plan B.
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