Audit faults FDA decision-making on emergency contraception

Tuesday, November 15th 2005, 8:52 am

By: News On 6

WASHINGTON (AP) _ Lawmakers are again accusing the Food and Drug Administration of putting politics over science in the long-running saga over whether the morning-after pill should sell without a prescription.

A congressional audit released Monday cited ``unusual'' steps in the FDA's initial rejection of over-the-counter emergency contraception, including conflicting accounts of whether top officials made the decision even before scientists finished reviewing the evidence.

The FDA is reconsidering the decision on the pill, sold under the brand Plan B. While the report by the Government Accountability Office, Congress' investigative arm, doesn't say that FDA made the wrong decision, it does raise the most serious questions to date about agency credibility _ and increases pressure to settle the issue.

``Regardless of how you feel about whether Plan B should be available in the community, the fact is the FDA decision should be based on science, not cultural controversy,'' said Sen. Barbara Mikulski, D-Md.

``The FDA's mission is to improve our health, not play to a political base, and right now it's failing at its mission,'' added Rep. Carolyn Maloney, D-N.Y.

In a statement, the FDA stood by its rejection and said the audit ``mischaracterizes facts.''

``We question the integrity of the investigative process that results in such partial conclusions,'' the agency said.

A high dose of regular birth control, the morning-after pill can lower 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 the Plan B brand 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 it 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.

Maker Barr Laboratories reapplied, seeking to sell Plan B with age limits similar to those required for cigarettes: Females 16 or older could buy it without a prescription but younger teens would continue to need a doctor's note. In August, FDA leaders postponed a decision indefinitely, saying it wasn't clear how to enforce an age limit.

The result was unprecedented public discord from the normally secretive agency: Top-ranking FDA officials have acknowledged they overruled their own scientists' decision that nonprescription sales would be safe, and the women's health chief resigned in protest.

Asked to investigate FDA's initial rejection, the GAO found:

_Minutes of a Jan. 15, 2004, meeting show that Dr. Steven Galson, then acting drug chief, told employees that rejection was ``recommended'' because of the young-teen question even though they hadn't finished reviewing the science. Other FDA officials told investigators that they, too, were informed a decision had already been made.

Galson denied making a final ruling until he had reviewed his employees' evidence a few weeks prior to the May rejection, although GAO said he did acknowledge that he was ``90 percent sure'' as early as January.

_There was unusual involvement from high-ranking officials. During a Feb. 18, 2004, meeting, reviewers told then-Commissioner Mark McClellan there was no evidence to back Galson's concerns about young teens. Minutes show McClellan questioned those conclusions.

_Three FDA directors who normally would have been responsible for signing off on the drug's fate did not do so. They weren't asked to, and Galson did instead, because they were known to disagree with the decision.

_The age rationale was novel; FDA never before required special teen evidence for birth control but could have extrapolated data from older teens showing no effect on sexual behavior.

In a letter Monday, 18 lawmakers asked FDA's boss, Health and Human Services Secretary Mike Leavitt, to intervene to ensure the agency's final decision on Plan B isn't based on ideology. They also asked Leavitt to probe whether FDA illegally destroyed documents from McClellan's tenure that might have shed more light on the decision.

Leavitt's office didn't return phone calls.

Plan B remains on sale by prescription _ except in eight states that have passed laws lifting that requirement on their own _ while FDA evaluates public comments on whether to allow age-limited nonprescription sales.