"This case is not about the potential misuse of Plan B by 11-year-olds," said Korman, who called the pills safe for girls but said the number using them "is likely to be minuscule" as less than 3 percent of girls under age 13 are sexually active.
He cited the Administrative Procedure Act as granting a judge the authority to set aside an agency's rulings "if they are 'arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law.'"
Korman said regulation requires that when the FDA allows nonprescription drug sales, "the standards are the same for aspirin and for contraceptives" — and he ultimately determined that the government violated those standards in the case of Plan B.
"The decision that the agency was forced to make, contrary to its own policies and judgment, is not entitled to any deference," Korman concluded. "Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable."
It was the judge's latest ruling in a lawsuit filed by the Center for Reproductive Rights and dating back to 2005 that pushed for unfettered over-the-counter access to Plan B.
Korman didn't spare the FDA from criticism, citing "a strong showing of bad faith and improper political influence" going back to the Bush administration, when the center filed a citizen's petition to try to get the agency to act. That was followed by the lawsuit.
"More than twelve years have passed since the citizen petition was filed and eight years since this lawsuit commenced," Korman wrote in a decision dated Thursday and released Friday. "The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster."
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.
Four years ago, Korman was highly critical of the Bush administration's initial handling of the issue when he ordered the FDA to let 17-year-olds obtain the medication, instead of setting the age at 18. At the time, he accused the government of letting "political considerations, delays and implausible justifications for decision-making" cloud the approval process.
The morning-after pill contains a higher dose of the female progestin hormone than is in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent. But it works best within the first 24 hours.
If a woman already is pregnant, the pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn't begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus, a contention that many scientists — and Korman, in his ruling — said has been discredited.
Neumeister reported from New York. Associated Press writer Ricardo Alonso-Zaldivar contributed to this report.