WASHINGTON — Federal drug regulators compromised their usual science-based decision-making process when they ruled in 2004 against letting the "morning-after" birth control pill be sold without a prescription, congressional investigators said Monday.
A detailed report by the nonpartisan Government Accountability Office bolstered critics' charges that the Food and Drug Administration had yielded to political pressure from social conservatives, who feared that easier access to the drug would encourage promiscuity.
In an examination of the agency's May 2004 decision, the GAO found that "four aspects of [the] review process were unusual" and that the entire decision-making process was "not typical" when compared with similar cases.
The contraceptive, manufactured by Barr Laboratories Inc. and marketed as Plan B, contains a higher dose of a hormone that also is in regular birth-control pills. It should be taken within 72 hours of unprotected sex but is most effective in preventing pregnancy when taken in the first 24 hours. Plan B has been available by prescription since 1999, but a decision on over-the-counter sales remains in regulatory limbo after another round of delays this year by the FDA.
The fight over Plan B has focused on both moral and legal issues. Conservative groups contend that making the drug freely available to girls under 16 would encourage them to have sex. Requiring a prescription discourages such behavior among adolescents who may not be emotionally prepared for intercourse, conservatives say.
Some women's groups and scientific experts counter that making emergency contraception widely available would dramatically reduce abortions. They have also expressed legal concerns about using age as the basis for restricting access to the drug.
"GAO's final report describes an appalling level of manipulation and suppression of the science," said Rep. Henry A. Waxman (D-Los Angeles), who requested the inquiry. "It appears that the decision
His criticism was joined by Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.), who also had sought a GAO probe.
"How can American consumers regain confidence in the FDA if science is so clearly overlooked by its leading officials?" they said in a joint statement. "Despite overwhelming evidence that Plan B is safe and effective, politics trumped science in this case."
