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Investigation Finds FDA Rejected Plan B Before Study...s Completion

By Gardiner Harris


Top federal drug officials decided to reject an application to allow over-the-counter sales of the morning-after pill months before a government scientific review of the application was even completed, according to accounts given to congressional investigators.

The Government Accountability Office, a nonpartisan investigative arm of Congress, concluded in a report released Monday that the Food and Drug Administration’s May 2004 rejection of the morning-after pill, or emergency contraceptive, application was unusual in several respects.

Top agency officials were deeply involved in the decision, which was “very, very rare,” a top FDA review official told investigators. Top officials’ decision to ignore the recommendation of an independent advisory committee as well as the agency’s own scientific review staff was unprecedented, the GAO found. And a top official’s “novel” rationale for rejecting the application contradicted past FDA practices, the report concluded.

“For example, FDA review staff told us that they were told early in the review process that the decision would be made by high-level management,” the report said.

Top agency officials denied many of the GAO’s allegations, including its conclusion that top officials’ involvement was unusual and that top officials had decided to reject the application even before the agency’s own scientific review was concluded. The investigation was requested by 30 House members and 17 senators.

Julie Zawisza, an FDA spokeswoman, said that the agency stood by its rejection of the morning-after pill application. “We question the integrity of the investigative process that results in such partial conclusions by the GAO,” she said.

After Sen. Patty Murray, D-Wash., denounced the FDA’s Plan B decisions during a Nov. 2 hearing on pandemic flu, Health and Human Services Secretary Michael O. Leavitt said that the agency had acted appropriately.

Dr. Susan F. Wood, former director of the FDA’s office of women’s health, said that what she described as the FDA’s willingness to ignore science in the service of abortion politics has “only gotten worse” since the events that were the focus of the GAO investigation. Wood resigned in August after the agency decided to delay once again its decision regarding the morning-after pill known as Plan B.

Murray and Sen. Hillary Rodham Clinton, a Democrat from New York, issued a statement on Monday saying that the auditors’ report “has confirmed what we have always suspected, that this was a politically motivated decision that came down from the highest levels at the FDA.”

Eighteen Democratic House members signed a letter of protest to Leavitt on Monday. The letter noted that congressional investigators had been unable to uncover the role played by former FDA Commissioner Mark McClellan in the Plan B decision because agency officials told investigators that all of McClellan’s e-mails and written correspondence regarding Plan B had been deleted or thrown out.