Senior Food and Drug Administration officials were told that the application to sell the "morning-after pill" without prescription was going to be rejected before the staff completed its scientific review and months before the decision was made public, government investigators reported yesterday.
A report by the independent Government Accountability Office also said senior FDA officials, including then-Commissioner Mark B. McClellan, were actively involved in the politically sensitive decision -- one of four aspects of the agency's actions that the investigators called "unusual."
The GAO report, requested by Congress more than 16 months ago, said the agency did not follow its normal procedures in making the scientific assessment of the Plan B proposal and in having a top official sign off on the eventual decision after lower-ranking scientists refused.
Critics of the FDA's handling of the issue said the report confirmed their view that the agency had allowed politics to trump science. The application was strongly opposed by some social and religious conservatives, including 49 members of Congress who wrote a letter to President Bush asking that the application be rejected.
The FDA, in a statement responding to the report, said: "We question the integrity of the investigative process that results in such partial conclusions by the GAO. The report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA."
But Susan F. Wood, a former FDA assistant commissioner for women's health who left her job to protest the agency's actions, said: "This report is a sad reminder of why I felt compelled to resign. Instead of improving and advancing women's health, the FDA leadership is ignoring its process and not relying on science and medical evidence."
The GAO report said then-Commissioner McClellan raised numerous objections to the proposal for over-the-counter sales of Plan B in a staff meeting three months before it was rejected.
The report also said that McClellan, who left the FDA two months before the rejection was announced to run the Centers for Medicare and Medicaid Services, did not respond to written questions from the GAO except to say that he left before the decision was made and that his actions had been "consistent with his usual practices."
In a letter to Health and Human Services Secretary Mike Leavitt, Reps. Henry A. Waxman (D-Calif.) and John D. Dingell (D-Mich.) said the GAO was unable to fully assess McClellan's role because he would not speak with investigators and because the agency provided no documents reflecting his communications with other officials. The FDA told the investigators that e-mails to and from McClellan had been deleted and that written memos were routinely destroyed.
Raising the possibility that this practice was a violation of federal record-keeping law, the congressmen wrote that "as the Plan B decision makes clear, retaining the documents of the agency head is essential for the transparent operation of government."
Plan B, manufactured by Barr Laboratories, is an emergency contraceptive that can prevent pregnancy if taken within 72 hours of unprotected sex. The drug was approved by the FDA 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.
Critics of the Plan B decision have charged that the decision was made in the White House, which was under pressure from conservative activists who believe over-the-counter availability of Plan B would promote teenage promiscuity. Some also believe Plan B causes abortions, although the FDA considers it to be a contraceptive.