June 20, 2006
Crawford explains Plan B delay
The FDA was prepared to allow over-the-counter sales of the Plan B contraceptive but delayed a decision until restrictions on use could be worked out, its former commissioner said.
Lester Crawford, testifying as part of a lawsuit against the FDA for not making Barr Labs’ Plan B available without a prescription, said that the agency was not preparing to deny the application for OTC sales last August when it announced a 60-day public comment period and an administrative rulemaking process on Plan B.
Instead, the move was a play for more time while the agency could “get straight what the enforcement procedures would be” for restricting nonprescription sales to females 17 and older, Crawford said in the deposition. Girls 16 and younger would still need a prescription.
Crawford said he expected it would take six to nine months after the announcement to work out the enforcement issue. He resigned from the agency in September and, nearly nine months later, the FDA still has not announced a Plan B decision.
Crawford’s May deposition was released this month by the Center for Reproductive Rights, which is bringing the suit to force the FDA to allow OTC sales.
Crawford also confirmed something that other high-level officials said while being deposed for the case: he reserved the right to decide whether to loosen the restrictions on Plan B, effectively taking the decision out of their hands.
As part of its case, the center has deposed another former commissioner, Dr. Mark McClellan, Deputy Commissioner, along with Dr. Janet Woodcock, and Director of the Center for Drug Evaluation and Research Dr. Steven Galson.
Next month, lawyers plan to question Dr. Susan Wood, formerly the director of the Office of Women’s Health, who resigned last August in protest of the agency’s handling of Plan B.