A federal judge has ordered the FDA to make the so-called "morning-after pill" available over the counter to girls regardless of how old they are.
The ruling in federal court in Brooklyn, released Friday, changes the order that now requires girls 16 and under to have a prescription.
The purpose of the morning-after pill is for emergency contraception. It prevents pregnancy after unprotected sex.
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The Center for Reproductive Rights and other groups have argued that contraceptives are held to a different and non-scientific standard than other drugs and that politics has played a role in decision making. Social conservatives have said the pill is tantamount to abortion.
Judge Edward Korman has given the FDA 30 days to comply.
F. Franklin Amanat, a lawyer for the government, said the Department of Justice has no immediate comment.
"We are reviewing the decision and evaluating the government's options," he said.
Andrea Costello, an attorney with the Partnership for Civil Justice Fund, called it a landmark victory.
"This is a landmark decision in terms of providing women and girls in the United States access to a safe and effective form of birth control," Costello said.
The FDA was preparing to let the pill be sold without a prescription or age limit when, in 2011, Health and Human Services Secretary Kathleen Sebelius overruled FDA scientists and said the age restrictions should remain in place. President Barack Obama said he supported the decision.
The judge said the case isn't about the potential misuse of the morning-after pill by 11-year-olds. He said the contraceptives would be among the safest drugs sold over-the-counter and the number of 11-year-olds likely to use the drugs was minuscule.