The Food and Drug Administration must make emergency contraceptives available to girls of all ages within 30 days, a federal judge has ruled, saying the agency's decisions regarding the so-called morning-after pill were "arbitrary, capricious and unreasonable.
Judge Edward Korman in Brooklyn released the decision Friday, though it was dated Thursday. He had warned in the past that he was unhappy with the way the FDA had handled the issue, saying it had failed to engage in rulemaking to adopt an age-restricted marketing regime.
The Center for Reproductive Rights and other groups have argued that contraceptives are being 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.
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 morning-after pill currently is available without a prescription only to those 17 and older who can prove their age. Younger teens must get a prescription.
The Food and Drug Administration 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 regarding a pill that can prevent pregnancy if taken soon enough after unprotected sex.
The judge said the FDA decided after 11 months, 47,000 public comments and hundreds of thousands, if not millions, of dollars spent, that it did not need rulemaking on the subject.
"The plaintiffs should not be forced to endure, nor should the agency's misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction," he wrote.
He 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.
Four years ago, Korman was highly critical of the government's handling of the issue when he ordered the FDA to let 17-year-olds obtain the medication. At the time, he accused the government of letting "political considerations, delays and implausible justifications for decision-making" cloud the approval process.