FDA, safety and politics enmeshed

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FDA, safety and politics enmeshed By Rita Rubin, USA

TODAY

Tue Dec 27, 7:29 AM ET

Concerns about drug safety and political meddling

dogged the Food and Drug Administration in 2005.

The culmination was Commissioner Lester Crawford's

abrupt resignation in September, just two months after

his confirmation. In an e-mail to FDA staff, Crawford

said that at age 67, it was time to resign.

Crawford's tenure as FDA chief, which after two stints

as acting commissioner added up to two years, was

marked by controversy:

• Safety concerns led to the withdrawal of two popular

arthritis drugs: Vioxx in September 2004 and

Bextra in April of this year.

• In July and September, the FDA issued " approvable

letters " to the makers of two silicone-gel breast

implants, meaning the companies can market their

products as soon as they answer remaining questions.

Opponents said the companies haven't studied patients

long enough to prove the devices are safe.

• Some members of Congress held up Crawford's

confirmation because the FDA had not yet allowed Plan

B emergency contraception to be sold over-the-counter.

Although an FDA advisory panel and agency scientists

endorsed selling Plan B over-the-counter, the FDA has

yet to decide. In August, Crawford said there were

still questions about the manufacturer's proposal to

sell Plan B without a prescription to older

adolescents and women and only by prescription to

younger teens and girls.

Opponents charged that politics - namely, the belief

that Plan B aborts rather than prevents pregnancies -

trumped science. In August, Wood, head of the

FDA's women's health office, quit in protest. In

November, the Government Accountability Office

called the FDA's Plan B decision-making process

" unusual. "

In an e-mail, Deputy Commissioner Gottlieb said

the FDA made " unprecedented efforts " in 2005 to

" provide better information about both health advances

and safety concerns. " He said that " one of our top

priorities is to make sure the public " has " truthful,

scientifically rigorous and up-to-date information " on

which to base decisions.

After Crawford resigned, the Bush administration named

National Cancer Institute director von

Eschenbach to be acting FDA commissioner. Skeptics

questioned the logistics and the potential conflicts

of interest in von Eschenbach holding both jobs, so he

went on a leave of absence from the cancer institute.