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http://www.thenewstribune.com/news/local/story/5203280p-4728771c.html

FDA chief abruptly resigns under fire

LES BLUMENTHAL; The News Tribune

Published: September 24th, 2005 12:01 AM

WASHINGTON – Lester Crawford, whose days as head of

the Food And Drug Administration were marked by

controversy, most recently involving over-the-counter

sales of a “morning after” contraceptive, resigned

Friday.

In a memo to FDA staff, Crawford said at age 67 and

after 31/2 years as the FDA’s deputy commissioner,

acting commissioner and commissioner, it was time to

“step aside.”

The announcement came just two months after the U.S.

Senate elevated him to commissioner.

He offered no elaboration but said the FDA

accomplished “great things for public health” during

his tenure, including steps to improve drug safety,

reforms to speed drug development and introduction of

manufacturer-paid fees to help fund the agency.

However, the agency also was criticized for the way it

handled the decision to pull the popular painkiller

Vioxx off the market after safety concerns were

raised. And it was criticized for delays in adopting

new cattle feed standards to guard against mad cow

disease and for seeking to loosen restrictions on

sales of silicone-gel breast implants.

Over the past several months, Crawford had tangled

with Sen. Patty Murray (D-Seattle) over delays in

deciding whether to allow nonprescription sales of the

emergency contraceptive Plan B.

“Dr. Crawford’s ability to lead a strong and

independent FDA was in question from the start,”

Murray said in a statement Friday. “Unfortunately,

during his tenure the FDA’s reputation as the gold

standard in public health has been tarnished.”

Crawford, a veterinarian who specialized in food

safety, was confirmed by the Senate just two months

ago after Murray and Sen. Hillary Rodham Clinton

(D-N.Y.), had removed a hold they had placed on his

nomination.

The two senators agreed to support his nomination only

after Health and Human Services Secretary Mike Leavitt

promised that the FDA would make a decision on

nonprescription sales of Plan B by Sept. 1. Just days

before the deadline, Crawford announced that action

was postponed indefinitely.

The delay prompted the resignation of Wood, an

assistant FDA commissioner in charge of women’s health

issues.

Murray said Crawford’s resignation offers President

Bush an opportunity to appoint someone who will

restore confidence in the FDA.

Democrats were not the only ones critical of

Crawford’s FDA.

“In recent years, the FDA has demonstrated a too-cozy

relationship with the pharmaceutical industry and an

attitude of shielding rather than disclosing

information,” said Sen. Grassley (R-Iowa), who

as chairman of the Senate Finance Committee has spent

the last 18 months tracking the agency’s actions.

Les Blumenthal: 202-383-0008

lblumenthal@...

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