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.
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.
“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.”
