A federal judge ruled Friday that the government must make the most common morning-after pill available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. In his ruling, he also accused the federal government of “bad faith” in dealing with the requests to make the pill universally available and said its actions had been politically motivated.
The decision comes after a decade-long fight over who should have access to the pill and under what circumstances. And it counteracts an unprecedented move by the President Barack Obama administration’s health and human services secretary, Kathleen Sebelius, who in 2011 overruled a recommendation by the Food and Drug Administration to make the pill available for all ages without a prescription.
In a decision in a lawsuit filed by advocates, the judge, Edward Korman of U.S. District Court, ruled that the government’s refusal to lift restrictions on access to the pill was “arbitrary, capricious, and unreasonable.”
Korman, who was appointed by President Ronald Reagan, ordered the FDA to lift any age and sale restrictions on the pill, Plan B One-Step, and its generic versions, within 30 days.
“More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced,” the judge wrote. “The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.”
He added, “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.”
The FDA and the Department of Health and Human Services declined to comment on the ruling or the judge’s harsh criticisms Friday morning or indicate whether the government would file an appeal, saying the decision, which was issued in the Eastern District of New York, was being reviewed. The Justice Department would only say it was reviewing the opinion.
Obama had supported the 2011 decision setting age limits, and White House spokesman Jay Carney said Friday the president hasn’t changed his position. “He believes it was the right common-sense approach to this issue,” Carney said.
Scientists, including those at the FDA, have been recommending unrestricted access for years, as have major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics.
Women’s health specialists hailed the ruling.
“It has been clear for a long time that the medical and scientific community think this should be fully over the counter and is safe for women of all ages to use,” said Dr. Susan Wood, who resigned as FDA’s women’s health chief in 2005 to protest President George W. Bush’s administration foot-dragging over Plan B.
Social conservatives criticized the ruling.
“There is a real danger that Plan B may be given to young girls, under coercion or without their consent,” said Anna Higgins of the Family Research Council. “The involvement of parents and medical professionals acts as a safeguard for these young girls. However, today’s ruling removes these common-sense protections.”
The drug’s manufacturer, Teva Pharmaceuticals, declined to comment on the court decision handed down Friday. As far back as 2003, the manufacturer had petitioned the FDA for Plan B to be available over the counter.
Information for this article was contributed by Pam Belluck of The New York Times; and by Larry Neumeister, Lauran Neergaard, and Ricardo Alonso-Zaldivar of The Associated Press.
Front Section, Pages 4 on 04/06/2013