With the heat turned up on the Food and Drug Administration regarding its failings as a consumer watchdog, the Bush administration has decided that the man already in place is the one to battle the blaze.
The White House announced it was nominating Lester Crawford, who has served as acting commissioner of the FDA since March 2004, for the post.
Critics were quick to express disappointment that the administration hadn't turned to an outsider to show it was serious about addressing the agency's shortcomings. Though Dr. Crawford is expected to be confirmed by the Senate, the process will undoubtedly provide yet another forum for critiquing the embattled agency.
"I was hoping for someone who could actually redirect the agency to what its legal and legislative mission is: to protect the public from unsafe drugs," says Vera Hassner Sharav, president of the Alliance for Human Research Protection and a longtime FDA critic. "Instead, the agency is in the business of fast-tracking the approval of drugs even before they've been found to be safe."
In recent months, a simmering stew of issues has kept the FDA under constant scrutiny. Concerns that antidepressant drug use among children could increase their risk of suicide in turn raised cries for a more open policy on publication of clinical trials by drug companies, and spurred questions on the FDA's role in promoting that openness.
Last fall, the FDA seemed to be caught by surprise when half of the annual supply of flu vaccine, about 40 million doses, was declared tainted and unsafe for use. As the public fretted and waited in long lines for the existing doses, the government scrambled to find new supplies. In the end, a mild flu season has left the nation with an oversupply of doses.
Wednesday an advisory panel to the FDA begins three days of hearings on heavily marketed and highly popular painkillers known as Cox-2 inhibitors. One, with the brand name Vioxx, has been voluntarily removed from the market by its manufacturer, Merck. Two others, Celebrex and Bextra, made by Pfizer, remain on the market. In a number of studies, the drugs have been implicated in higher incidences of fatal heart attacks and other cardiovascular problems.
Critics have questioned why the FDA has taken so long to recognize the problem and take action. The agency could ask for strong warnings on the products or demand their removal from the market. David Graham, a whistle-blower within the FDA, will be allowed to testify, but has said he does not feel free to present new unpublished data about the drugs.
In an editorial released Wednesday, accompanying three more studies linking Cox-2 drugs to heart problems, Jeffrey Drazen, editor of the New England Journal of Medicine, wrote that "It is reasonable to ask whether the use of the drugs can now be justified" and said that the same zeal that had suggested the drugs offered new benefits to patients had not been applied to ensuring that they were safe.
The press reports have sent patients and doctors fleeing from the drugs. Sales of Cox-2 drugs dropped 43 percent in December from a year earlier, according data released by IMS Health in Plymouth Meeting, Pa. "I've been in practice for 30 years, and I've never seen such a mess," Michel Dubois, director of the New York University Pain Management Center, told the Associated Press.
Tuesday, the FDA announced it would be establishing an independent drug-safety oversight board to help ensure the safety of drugs already in the marketplace. A number of critics had been calling for such a step as part of revamping the FDA.
"Dr. Lester Crawford is an outstanding choice for Commissioner of the Food and Drug Administration," said Mike Leavitt, Secretary of Health and Human Services, in announcing the nomination Monday. "Dr. Crawford has dedicated his career to advancing the nation's public health and will lead the way as we enter a new era of individualized medicine and rapidly developing science. With Dr. Crawford's leadership, the FDA will provide the world's safest drugs and empower citizens with the tools they need to make informed choices about their health."
Crawford's background is in veterinary medicine and pharmacology. Before joining the FDA he worked in the food industry for the National Food Processors Association.
Among the topics likely to be discussed at his Senate hearing is the FDA's proposed budget. Though overall funding would increase about 4.5 percent under the president's budget proposal, the plan also calls for the FDA to cut the number of inspections of food-processing plants, blood banks, and foreign drug plants, USA Today reported Tuesday. New funding would be put into fighting bioterrorism and establishing the drug-safety office.
• Material from wire services was used in this report.