Ruling: Morning- after pill must be available for all

The New York TimesApril 5, 2013 

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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, on a politically controversial subject, 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 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 R. 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 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.

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.

They contend that the restrictions effectively keep many adolescents and younger teenagers from being able to use a safe drug in a timely way to prevent pregnancy, which carries greater safety risks than the morning-after pill.

In 2011, the FDA commissioner, Dr. Margaret A. Hamburg, issued a statement saying that after rigorous study, it was safe to sell Plan B One-Step over the counter for all ages. But she was overruled by Sebelius, the Health and Human Services secretary, the first time such a public countermanding had ever occurred.

In her decision, Sebelius said that Plan B’s manufacturer had failed to study whether the drug was safe for girls as young as 11, about 10 percent of whom are physically able to bear children. But her decision was widely interpreted in a political context because emergency contraception has become an issue in the abortion debate and because allowing freer access to adolescents would prompt critics to accuse the Obama administration of supporting sexual activity for girls of that age. At the time, President Barack Obama supported Sebelius’ decision, saying, “I will say this, as the father of two daughters: I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.”

He added: “And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.”

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.

Plan B was approved in 1999 as a prescription-only product, and in 2001, the Center for Reproductive Rights filed a citizens petition for it to be made available over the counter or without a prescription. Scientists, including an expert advisory panel to the FDA, gave early support to that request. But top FDA officials rejected the application because, some said later, they worried they would be fired if they approved it.

After years of FDA delay on a promise to reconsider the morning-after pill decision, and as the lawsuit by advocates wound its way through the courts, the Bush administration in 2006 allowed over-the-counter sales to women 18 and older but required a prescription for those 17 and younger. Then in 2009, Korman issued a ruling in the court case directing that the pill be made available over the counter for those 17 and older. In his 2009 ruling, the judge said the government’s actions on the pill had been driven by politics and not science.

In his ruling Friday, Korman also raised the issue of politics, saying that Sebelius’ decision was “politically motivated, scientifically unjustified, and contrary to agency precedent.”

Plan B One-Step consists of one pill with the active ingredient levonorgestrel, which can block fertilization if taken within 72 hours of sexual intercourse. It reduces the chance of pregnancy to 1 in 40; without the pill, women have about a 1 in 20 chance of becoming pregnant after unprotected sex. Two other drugs — Next Choice and Levonorgestrel Tablets — contain levonorgestrel in a two-pill version. The judge’s order also applies to those pills, although he said that if the FDA “actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product.”

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