By Rob Stein
Washington Post Staff Writer
Thursday, April 23, 2009
The federal government said yesterday that it will allow the sale of the morning-after pill Plan B without a prescription to women as young as 17, a move that would make the contraceptive available to minors for the first time without a doctor's order.
The Food and Drug Administration took the action to comply with a judge's ruling last month holding that the agency's 2006 decision to limit availability of the controversial contraceptive to women 18 and older was invalid and politically motivated.
In a statement posted on its Web site, the FDA said it had notified the company that makes Plan B that it will approve sales to 17-year-olds at the manufacturer's request -- a request a company spokeswoman said it will make.
The FDA's decision was welcomed by women's health and family planning advocates, who had challenged the agency's original decision in federal court.
"It's a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science," said Nancy Northup, president of the Center for Reproductive Rights, one of the groups that challenged the FDA's age limitations in court. "It's time the FDA restores confidence in its ability to safeguard the public health and put medical science first."
The announcement was condemned by opponents, who questioned Plan B's safety.
"This decision is driven by politics, not what is good for patients or minors," said Wendy Wright of Concerned Women for America. "Parents should be furious at the FDA's complete disregard of parental rights and the safety of minors."
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.
Barr Pharmaceuticals, which makes Plan B, asked the FDA in 2003 to allow the contraceptive to be sold without a prescription.
Advocacy groups and conservative members of Congress opposed the request. They questioned the drug's safety and argued that wider availability could encourage sexual activity and make it easier for men to have sex with underage girls. They also maintain that Plan B can cause the equivalent of an abortion.
The FDA delayed its decision for three years even though its outside advisers and internal reviewers endorsed nonprescription sale, leading to criticism that politics influenced the decision.
The agency eventually approved nonprescription sale in August 2006, allowing pharmacists to dispense the drug from behind the counter. But the agency said that there was too little safety data to approve the drug for those younger than 18 and that pharmacists would be unable to enforce the age cutoff.
But in response to the lawsuit, U.S. District Judge Edward R. Korman in New York instructed the agency on March 23 to make Plan B available to 17-year-olds within 30 days and to reconsider other restrictions, including whether the drug could be made available to all ages.
In his 52-page decision, Korman repeatedly criticized the FDA's handling of the issue, agreeing with allegations in the lawsuit that the original decision was "arbitrary and capricious" and influenced by "political and ideological" considerations of the Bush administration.
It remains unclear, however, if the agency will review whether Plan B should be available to those younger than 17. Suzanne Novak, a senior staff attorney at the Center for Reproductive Rights, said the FDA was required to review all restrictions.
"It has to do it," she said. "They are under court order."
But government health officials said the agency would consider other issues only if requested by the company, and Denise Bradley of Teva Pharmaceuticals, which owns Barr, said the company has no plans to market Plan B to anyone younger than 17.