WASHINGTON, April 23 -- In a quiet to a years' long struggle, the FDA has agreed to allow 17-year-olds to purchase levonorgestrel (Plan B) birth control pills over-the-counter.
The FDA announcement followed a federal court ruling last month that found that the agency's initial decision to restrict access was based on politics, not science. (See: Court Finds FDA Played Politics with Emergency Contraception)
The FDA said it will not appeal the court's decision, and has informed drug maker Duramed Pharmaceuticals that it will be able to market Plan B to women ages 17 and older pending approval of a marketing application.
On March 23, U.S. District Court for the Eastern District of New York gave the FDA 30 days to review its 2006 decision approving over-the-counter sales of the drug only for patients ages 18 and up. Women under that age needed a prescription to purchase the drug, the agency mandated.
The court ordered the FDA to allow 17-year-olds to buy the drug without a prescription.
The FDA did not return calls for comment on whether the drug will still be sold behind the counter rather than openly on store shelves.
The 2006 decision had been drawn out over a period of three years as the Bush administration opposed FDA approval of Plan B, citing "safety concerns," even though FDA advisory panels recommended the sale of the drug without age limitations.
In a statement, Cecile Richards, president of Planned Parenthood Federation of America, called the announcement "a strong statement to American women that their health comes before politics."
"This decision is commonsense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women," she said.
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