Drug safety dominates hearing for FDA chief

Nominee says he's open to an independent unit within embattled agency

March 18, 2005|By Ricardo Alonso-Zaldivar | Ricardo Alonso-Zaldivar,LOS ANGELES TIMES

WASHINGTON - President Bush's nominee to head the Food and Drug Administration told a Senate panel yesterday 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 has announced to deal with concerns that the agency is failing to detect deadly side effects in drugs approved for widespread use.

And it would fulfill a key goal of congressional reformers, who believe the FDA has created a conflict by requiring the office that monitors the safety of approved drugs to report to the branch that grants 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 committee considering his nomination.

"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, a Connecticut Democrat, said after the hearing.

Crawford's nomination could run into powerful opposition unless he can convince senators that he will follow through with reforms at the FDA.

He faced sharp questioning yesterday 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 can be used safely by females 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.

"I don't think we've been tarnished," he 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.

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 of Maryland.

A panel vote on Crawford's nomination is set for mid-April.

The Los Angeles Times is a Tribune Publishing newspaper.

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