Probe of "morning-after" pill decision bolsters FDA's critics

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 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 to how similar cases have been handled.

The contraceptive, manufactured by Barr Laboratories and marketed as Plan B, contains a higher dose of a hormone 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.

The FDA approved the drug in 1999 as a prescription medication, but advocates say the time needed to get a doctor's appointment and prescription often makes emergency contraception far less effective.

Washington is among six states that allow pharmacists to prescribe Plan B.

"GAO's final report describes an appalling level of manipulation and suppression of the science," said Rep. Henry Waxman, D-Calif., who requested the inquiry. "It appears that the decision ... was preordained from the outset."

His criticism was joined by Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y. "This long-awaited report leaves no question that science was compromised in the FDA's decision making process on Plan B," they said in a joint statement. "... How can American consumers regain confidence in the FDA if science is so clearly overlooked by its leading officials?"

Waxman also questioned whether the FDA disposed of e-mails and other documents that may shed light on the role of then-FDA Commissioner Mark McClellan, who now heads the Centers for Medicare and Medicaid Services.

In a letter to Health and Human Services 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 "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 at the FDA.

Several midlevel 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.

However, agency superiors told the GAO investigators that they had never made such remarks, and 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, according to Waxman.

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.

Material from The Washington Post and Seattle Times archives is included in this report