FDA Must Reconsider Its Plan B Age Limit, Judge Rules
Tuesday, March 24, 2009
A federal judge ordered the Food and Drug Administration yesterday to reconsider its 2006 decision to deny girls younger than 18 access to the morning-after pill Plan B without a prescription.
U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor's order.
In his 52-page decision, Korman repeatedly criticized the FDA's handling of the issue, agreeing with allegations in a lawsuit that the decision was "arbitrary and capricious" and influenced by "political and ideological" considerations imposed by the Bush administration.
"These political considerations, delays and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making," he wrote. "Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug from prescription to non-prescription use."
FDA lawyers are reviewing the decision, said Rita Chappelle, an agency spokeswoman, who declined to comment further.
Critics of the FDA's decision hailed the ruling.
"We're very excited," said Suzanne Novak, a senior staff lawyer for the Center for Reproductive Rights, which filed the lawsuit. "The message is clear: The FDA has to put science first and leave politics at the door."
Opponents of Plan B condemned the judge's order.
"This ruling puts politics above women's health, and intrudes into parents' ability to protect their minor daughters," said Wendy Wright of the group Concerned Women for America. She also questioned the drug's effectiveness.
"Making the morning-after pill easy to get has not resulted in fewer pregnancies or abortions, as advocates promised it would," Wright said. "Pregnancy counselors report more young women relying on it as a regular form of birth control -- even though the drug has not been tested to discover what happens when it is used multiple times."
Plan B consists of higher doses of a hormone found in many standard birth-control pills. Taken within 72 hours of unprotected sex, it has been shown to be highly effective at preventing pregnancy.
With strong support from women's health groups and family planning advocates, Barr Pharmaceuticals, which makes Plan B, asked the FDA in 2003 to allow the drug to be sold without a prescription so women would not have to obtain a doctor's order to get it.