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.”
Waxman also questioned whether the FDA disposed of e-mails and other documents that could have shed light on the role of then-FDA Commissioner Mark B. McClellan, who now heads the Centers for Medicare & Medicaid Services, a part of the Department of Health and Human Services.
In a letter to HHS Secretary Mike Leavitt, Waxman said investigators told his staff that the commissioner’s office routinely deleted e-mails and did not retain memos and other documents.
“If what GAO was told is true, FDA’s policy appears to violate federal records law,” Waxman wrote.
In a statement, the FDA said: “We question the integrity of the investigative process that results in such partial conclusions by the GAO. The report mischaracterizes the facts and does not appear to take into consideration the [response] provided by the FDA. We stand by the original decision.”
The agency also contended that it had “complied fully” in turning over documents to congressional investigators.
“Any statement to the contrary is false,” the FDA statement read. “All steps were taken to retain the appropriate records of this decision.”
The GAO report provided a glimpse of internal conflict as a bureaucracy that prides itself on data-driven decisions struggled with a politically sensitive matter.
Several mid-level managers told congressional investigators they were notified by FDA superiors around January 2004 that easing access to Plan B “could not be approved.” Those marching orders were said to come from McClellan’s office, according to the report.
At the time, agency scientists had not concluded their evaluations, and the FDA did not announce its decision for four more months.
Agency superiors told the GAO that they had never made such remarks. McClellan told investigators in a statement that the decision not to approve the over-the-counter sale of Plan B was made after he left the agency in March.
GAO investigators also found that three separate FDA offices had recommended that Plan B be approved for sale without a prescription after reviewing data on safety and effectiveness. Two panels of outside advisors had reached the same conclusion at a joint meeting.
Nonetheless, the recommendations were overruled by Dr. Steven Galson, who now heads the Center for Drug Evaluation and Research and was then its acting director. Galson, in effect, instead suggested that drug maker Barr Laboratories consider a compromise: Younger adolescents would need a prescription, while other women would not.
The manufacturer ultimately went along with the idea. Then, in another twist, Galson was overruled.
McClellan’s successor as commissioner, Lester M. Crawford, said this summer that the agency needed more time to consider legal issues raised by requiring younger adolescents to have a prescription while allowing over-the-counter access for others. Crawford, who had promised the Senate a firm decision, resigned under pressure Sept. 23, for reasons still not fully explained.
“GAO found what parents would want: that the FDA handled a controversial drug with great caution,” said Wendy Wright, executive vice president of Concerned Women for America, a conservative public policy organization that opposes making Plan B available without a prescription. “Making Plan B available over the counter would needlessly expose adolescents to risks.
“There are people within the FDA in those lower divisions who have absolutely no concern for adolescents,” she continued. “Here, you have a corrective measure with the higher-ups saying, ‘We need to be more responsible.’ ”
But Susan F. Wood, the former head of the FDA’s office on women’s health, said the GAO report showed that the agency had lost its independence.
“The decision was contrary to the evidence and contrary to the consensus that had been reached by all the review levels below,” said Wood, who resigned Aug. 31 to protest the continued delays on Plan B.
“The process depends upon science and evidence to make decisions,” she said. “The problem was not in the scientific review. There was a lot of agreement [by drug reviewers] on what the decision should have been. We all depend on this process to ensure that the FDA is doing its job.”
Barr Laboratories had no comment on the GAO report, but said it would keep pressing for approval of over-the-counter sales.
The GAO said it found four areas in which the agency’s handling of the 2004 Plan B decision was “unusual":
* The heads of the FDA offices that reviewed Barr’s application -- Dr. Florence Houn, whose office deals with reproductive drugs, and Dr. Jonca Bull, responsible for over-the-counter medicines -- refused to sign the agency’s decision because they disagreed with it. Dr. John Jenkins, director of the Office of New Drugs, also disagreed and did not sign the decision.
* High-level management was more involved in the decision than is usually the case for over-the-counter approvals, the GAO said.
* Investigators cited the conflicting accounts among mid-level and senior managers over whether the decision to reject the request was made before scientific evaluations had been completed.
* The rationale for shielding younger adolescents “was novel and did not follow FDA’s traditional practices,” the report said. In the past, the agency had not made age distinctions when it came to contraceptive use.
The GAO also found that the entire decision was “not typical” when compared to other cases involving requests for over-the-counter approval. From 1994 through 2004, the FDA approved 67 medications for sale without a prescription. Plan B was the only drug denied approval after an advisory committee recommended it.