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It’s a Maybe for Drug Safety Unit

Times Staff Writer

President Bush’s nominee to head the Food and Drug Administration told a Senate panel Thursday that he would consider setting up an independent drug safety unit within the beleaguered agency, as some critics have demanded.

Such a watchdog office would go beyond fixes that the Bush administration had announced to deal with concerns that the FDA was failing to detect deadly side effects in drugs approved for widespread use.

And it would fulfill a key goal of congressional reformers, who contend the FDA had created a conflict by requiring the office that monitored the safety of approved drugs to report to the branch that granted approval in the first place.

“An independent office of drug safety is something I am certainly open to discussing,” acting FDA Commissioner Lester M. Crawford told the Health, Education, Labor and Pensions Committee, which is considering his nomination.

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“An independent drug safety office within the FDA ... is a critical step in restoring the public’s trust in the phrase ‘FDA-approved,’ ” Sen. Christopher J. Dodd (D-Conn.) said after the hearing. Dodd introduced legislation last week calling for such an office.

Crawford’s nomination could run into stiff opposition unless he can convince senators that he would follow through with changes at the FDA.

He faced sharp questioning Thursday from committee Democrats over drug safety and the FDA’s delay in deciding whether the morning-after pill should be available without a prescription. Crawford said the FDA was weeks away from a decision on the contraceptive, which would involve resolving the question of whether it could be used safely by women younger than 16.

Crawford, a veteran government manager who holds doctorates in pharmacology and veterinary medicine, tried to defend the FDA while simultaneously pledging to transform its internal culture.

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“I don’t think we’ve been tarnished,” Crawford said. “I don’t want to see that happen. The specter has been raised in the past few months.... I don’t want the FDA to be tarnished in any sense.”

Crawford was referring to recent controversies over how the FDA had dealt with the suicide dangers associated with antidepressants used by adolescents and the heart risks of a popular painkiller. In both cases, FDA scientists had unsuccessfully tried to warn their superiors of emerging problems.

Last fall, the FDA belatedly issued a strong warning that taking antidepressants could prompt suicidal thoughts and actions among some teenagers. That was followed by Merck’s withdrawal of its arthritis painkiller Vioxx, after a study confirmed suspicions that it increased chances of heart attacks and strokes.

“There is a crisis of confidence over drug safety in the public mind and even among some clinicians,” said Sen. Barbara A. Mikulski (D-Md.).

Sen. Edward M. Kennedy (D-Mass.) asked Crawford whether he felt there were any lapses in the agency’s handling of Vioxx. Crawford responded that the painkiller’s effects on the heart “could not have been anticipated.” That prompted an exasperated reaction from Kennedy.

“ ‘Couldn’t be anticipated’ is a rather ominous response,” Kennedy said. “I’m trying to detect whether it’s going to be business as usual. I’m not sure the American people are going to be satisfied by [Crawford’s saying] there are a number of situations that can’t be anticipated, and therefore that’s the way it should be.”

The Democratic critics have an influential Republican ally in Sen. Charles E. Grassley of Iowa. He heads the Finance Committee, which has jurisdiction over healthcare programs, although not the FDA.

After Thursday’s hearing, Grassley released a list of 30 questions he wanted answered before he made up his mind on Crawford’s nomination. Grassley accused the FDA of withholding information from Finance Committee investigators.

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The Bush administration acknowledges that the FDA needs to improve its oversight of drugs on the market. It has increased the budget of the FDA’s drug safety office and pledged to warn the public promptly about suspected or emerging risks. The FDA also is setting up a drug safety board, composed of government and independent experts, to advise the commissioner. But under the administration’s plan, the drug safety office, where FDA scientists and reviewers work, would remain part of the branch that approved new drugs.

“It needs to be independent of the whole bureaucracy, reporting only to the commissioner,” Mikulski told Crawford.

A committee vote on Crawford’s nomination is set for mid-April. The FDA has been without a permanent commissioner for a year.


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