It's a Maybe for Drug Safety Unit (per Nominee to head FDA)

[papau]

http://www.latimes.com/news/nationworld/nation/la-na-fda18mar18.story

THE NATION
It's a Maybe for Drug Safety Unit
Nominee to head FDA, pressed by senators, says he's open to discussing an independent office.
By Ricardo Alonso-Zaldivar
Times Staff Writer

March 18, 2005

WASHINGTON — 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.

"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.
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