FDA decision on pill called 'preordained'

WASHINGTON — Top federal health officials may have rejected easier access to the morning-after pill before reviewing all the scientific evidence, according to an independent audit Monday that renewed charges that politics trumped science.

Congressional auditors reported that the Food and Drug Administration's May 2004 decision on emergency contraception deviated from 10 years of agency practice in evaluating over-the-counter sales of prescription drugs — and was unusual in several respects.

Critics in Congress declared their suspicions confirmed and urged the FDA's boss to intervene to assure that a still pending reconsideration of the pill's fate isn't based on ideology.

"We are deeply opposed to this subversion of science," Rep. Henry Waxman, D-Calif., and 17 other lawmakers wrote Health and Human Services Secretary Mike Leavitt on Monday. "It appears that the decision . . . was preordained from the outset."

Also, the lawmakers asked Leavitt to probe whether the FDA illegally destroyed documents from the office of then-Commissioner Mark McClellan, now the government's Medicare chief, that might have shed more light on the controversial decision.

Monday's report is the latest blow to the credibility of an agency that by law is supposed to base decisions on science, not politics or industry pressure. Top-ranking FDA officials have acknowledged they overruled their own scientists' decision that nonprescription sales of emergency birth control would be safe — and the agency's women's health chief resigned in protest.

A high dose of regular birth control, the morning-after pill lowers the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex. The sooner it's taken, the better it works, but it can be difficult for women to get a prescription in time.

In December 2003, FDA's scientific advisers overwhelmingly backed over-the-counter sales of one brand, Plan B, for all ages. They cited assessments that easier access could halve the nation's 3 million annual unintended pregnancies.

Conservatives who consider the pill tantamount to abortion intensely lobbied the Bush administration to reject nonprescription sales, saying they would increase teen sex.

In May 2004, FDA leaders rejected the nonprescription switch, saying there was no data proving anyone under 16 could safely use the pills without a doctor's guidance.