Judge Orders F.D.A. to Make Morning-After Pill Available Over the Counter for All Ages

Written By Unknown on Sabtu, 06 April 2013 | 13.57

By Erica Berenstein, Channon Hodge, and Ben Werschkul

Easing Access to Contraception: The Times's Pam Belluck explains how the emergency nature of the morning-after pill pushed a federal judge to increase its availability.

A federal judge on Friday ordered that the most common morning-after pill be made available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. But his acidly worded decision raises a broader question about whether a cabinet secretary can decide on a drug's availability for reasons other than its safety and effectiveness.

In his ruling, Judge Edward R. Korman of the Eastern District of New York accused the Obama administration of putting politics ahead of science. He concluded that the administration had not made its decisions based on scientific guidelines, and that its refusal to lift restrictions on access to the pill, Plan B One-Step, was "arbitrary, capricious and unreasonable."

He said that when the Health and Human Services secretary, Kathleen Sebelius, countermanded a move by the Food and Drug Administration in 2011 to make the pill, which helps prevent pregnancy after sexual intercourse, universally available, "the secretary's action was politically motivated, scientifically unjustified, and contrary to agency precedent."

Ms. Sebelius said at the time that she was basing her decision on science because she said the 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 as political because emergency contraception had become an issue in the abortion debate and allowing freer access for adolescents would prompt critics to accuse the president of supporting sexual activity for girls of that age.

At the time, Mr. Obama was campaigning for re-election, and some Democrats said he was conscious of avoiding divisive issues that might alienate voters. He said then that he was not involved in the decision but supported it. "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 said.

And he reiterated that position on Friday through the White House press secretary, Jay Carney, who said, "He believed it was a common-sense approach when it comes to Plan B and its availability."

Mr. Carney declined to comment on whether the administration would appeal the decision. A Justice Department spokeswoman, Allison Price, said the department was reviewing the 59-page order and the appellate options and "expects to act promptly." Judge Korman gave the F.D.A. 30 days to lift any age and sale restrictions on Plan B One-Step and its generic versions.

Many groups that are part of Mr. Obama's political base praised the decision to make the emergency contraceptive pill more easily available, saying the change would also make it easier for all women to obtain the pill because stores often keep it behind the counter or in pharmacy sections that may close at night.

Removing the restrictions is in some ways is more consistent with the administration's position on other women's reproductive health issues, including the free provision of contraceptives through Mr. Obama's health care overhaul.

Scientists, including those at the Food and Drug Administration, have recommended unrestricted access for years, as have 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.

Conservative and anti-abortion groups assailed the judge's decision, suggesting that it may allow the pill to be given to young girls without their consent. They also say that girls who can skip the requirement to visit a doctor for a prescription may have sexually transmitted infections that go undiagnosed and untreated.

"This ruling places the health of young girls at risk," said Anna Higgins, director of the Center for Human Dignity at the Family Research Council.

The judge's decision, a rare case in which a court has weighed in to order that a drug be made available over the counter, could test the question of who gets the final say in such matters.

"Technically the secretary under the law has the right to make the decision," said Daniel Carpenter, a professor of government at Harvard. "But there is other long-established law that says the decision is supposed to be based on the safety and efficacy of the drug."

Some legal experts said the decision sent a strong signal to the White House.

"If they're going to interfere with decisions of expert regulatory agencies, they must find credible scientific justification; otherwise judges will be inclined to step in and stop them," said Lewis A. Grossman, a law professor at American University.

In his ruling, Judge Korman accused the federal government of "bad faith" in dealing with the requests over more than a decade to make the pill universally available.

"The F.D.A. has engaged in intolerable delays in processing the petition," the judge wrote. "Indeed, it could accurately be described as an administrative agency filibuster."

Michael D. Shear and Sabrina Tavernise contributed reporting.


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