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US plans to allow sale of 'morning-after' pill to minors

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By Rob Stein
Washington Post / April 23, 2009
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WASHINGTON - The federal government plans to announce that it would allow the sale of the morning-after pill Plan B without a prescription to women as young as 17, making the controversial contraceptive available to minors for the first time without a doctor's order, a federal official said.

The Food and Drug Administration agency is taking the action to comply with a judge's ruling last month that the agency's 2006 decision to limit availability of the contraceptive method to women 18 and older was invalid and politically motivated, the official said.

The FDA plans to notify the company that makes Plan B that it would approve the sale of the pill to 17-year-olds at the company's request.

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 that women would be able to obtain it without a doctor's order.

Conservative members of Congress and advocacy groups 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 maintained that Plan B can cause the equivalent of an abortion.

The FDA delayed its decision for three years despite endorsements of nonprescription sales by its outside advisers and internal reviewers, leading to intense criticism that the agency was allowing politics to influence the decision.

The agency eventually approved nonprescription sale in August 2006, allowing pharmacists to dispense the drug from behind the counter. Proponents were disappointed that the drug was limited to women age 18 and older. The FDA said there was too little safety data to approve the drug for teenagers younger than 18 and that pharmacists would be unable to enforce the age cutoff. The requirement also meant that women must show proof of their age when buying the drug, which made it more difficult for some women, such as illegal immigrants.

On March 23, US District Judge Edward 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 it available to all ages.

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.

In his ruling, Korman detailed repeated interference by "political actors" in the agency's handling of Plan B, including the long delay in approving the drug and the ultimate decision to act only after some senators tried to apply pressure by blocking confirmation of acting FDA commissioners.