WASHINGTON—Top officials at the Food and Drug Administration appear to have decided to block over-the-counter sales of a controversial emergency contraceptive months before completing their review of the application in 2004, a new government report said Monday.
According to the Government Accountability Office, top officials—some of them political appointees of President Bush—took "unusual" steps to impede the approval process.
The GAO's findings renew accusations of political meddling at the FDA, which has been criticized for more than two years for failing to bring the Plan B contraceptive to market despite the urging of its scientific staff.
When taken within 72 hours of intercourse, Plan B blocks conception with 89 percent reliability. Health advocates, women's groups and congressional Democrats charge that the FDA has been slow to approve nonprescription sales of the drug because of opposition from conservative groups that see it as a form of abortion.
The drug is available by prescription. In August, the FDA deferred action on making it available over the counter. The agency said it was safe for girls and women 17 and older but concluded that issues surrounding its potential sale to younger teens remained unresolved.
The GAO found that minutes of FDA meetings in January 2004 show that Dr. Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research, said former FDA Commissioner Lester Crawford already had decided to recommend blocking the application.
That decision was made months before the FDA completed its staff review of the application to sell the drug without a prescription, the report says.
In addition, FDA officials told GAO investigators that Galson and others had told them in late December 2003 and January 2004 that the Plan B application couldn't be approved because Crawford's office opposed it.
The report says Galson later denied making any such comments. Dr. Janet Woodcock, the FDA's deputy commissioner for operations, denied the allegations as well in a written response filed with the GAO.
The FDA didn't respond Monday to repeated requests for an interview.
In a written statement, FDA spokeswoman Julie Zawisza questioned the integrity of the GAO's investigative process. "We stand by the original decision," she said, to deny over-the-counter status to Plan B, which is made by Barr Pharmaceuticals.
In its 62-page report, which was requested by congressional Democrats, the GAO determined that high-ranking FDA officials were more involved in the Plan B review than in other similar applications and that the FDA's rationale for denying the initial Plan B application in May 2004 was "novel and did not follow FDA's traditional practices."
In addition, the report found that FDA officials, who usually would have signed the so-called "action letter" blocking Plan B's application, disagreed with the decision and didn't sign.
The report's findings are the latest attack on the credibility of the FDA, which has operated amid controversy for the last two years after it failed to act promptly on concerns about several unsafe medications. The agency has been hampered by the recent resignation of Crawford, who was the target of a sexual misconduct probe. His departure is still under investigation.
The GAO report has prompted calls from Democrats and women's rights groups for the FDA to finish its review of the Plan B application for over-the-counter sales to girls and women 17 and older. Both groups claim that the agency is dragging its feet for political reasons.
"Science was pushed aside when the FDA rejected the Plan B application," Rep. Henry Waxman, D-Calif., charged in a written statement. "Agency scientists were ignored and their analyses dismissed to further a narrow ideological agenda that most Americans reject."
Even though Barr Pharmaceuticals wants to require prescriptions for girls 16 and younger, the so-called "morning after pill" has had a rocky time getting over-the-counter status.
Two FDA advisory panels voted 23-4 in December 2003 to recommend that Plan B be sold without a prescription, finding that it was safe and effective.
But on May 6, 2004, the FDA rejected Barr's initial application for nonprescription sales, citing a lack of data about the drug's safety for younger adolescents. The decision was the first of 23 over-the-counter applications since 1997 that the FDA had denied after its advisory committees recommended approval.
Crawford, who resigned in September, said in August that the drug wouldn't be sold over-the-counter until the agency resolved whether its prescription and nonprescription versions could be marketed in the same package and whether the prescription requirement for young teens could be enforced effectively.
Dr. Susan Wood, the former assistant FDA commissioner for women's health and former director of the Office of Women's Health, resigned in protest after that decision. On Monday, she said the GAO report validated her concerns.
"This report is a sad reminder of why I felt compelled to resign: that instead of improving and advancing women's health, the FDA leadership is ignoring its process and not relying on science and medical evidence."
In a written response to the report, the FDA's Woodcock took issue with its contention that high-level FDA management was more involved in the Plan B review than usual. She said the level of public interest necessitated the involvement of top officials at the FDA's Center for Drug Evaluation and Research.
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(c) 2005, Knight Ridder/Tribune Information Services.
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