Morning-After Pill Judge Criticizes Bid to Delay Ruling

A federal judge criticized the government’s request to delay a ruling allowing girls over-the- counter access to the “morning after” pill while the administration appeals the order.

U.S. District Judge Edward R. Korman heard arguments today in Brooklyn, New York, over the government’s request. Korman ordered the U.S. Food and Drug Administration to make the emergency contraception available to all women and girls without a prescription.

Speaking to a government lawyer, Korman accused the Obama administration of unfairly burdening consumers by maintaining age limits for the drug, which would force them to present photo identification to make a purchase.

“You’re basically disadvantaging poor people, young people and African Americans,” Korman said, referring to data showing that those groups might be less likely to have photo IDs. “That’s the policy of the Obama administration?”

Korman said he expects to issue a decision on a delay by the end of the week.

Government lawyers have notified the court that they are appealing the April 5 ruling. The judge’s decision followed a reproductive-rights group’s request to reopen a lawsuit over access to emergency contraception using the drug levonorgestrel.

The morning-after pill is “a powerful systemic hormone, a metabolic steroid,” said F. Franklin Amanat, a lawyer with the U.S. Attorney’s Office. “FDA has proceeded with baby steps instead of a full gallop” in making the drug more accessible.

Secretary’s Decision

The FDA in December 2011 was set to approve sales of Teva Pharmaceutical Industries Ltd.’s Plan B One-Step, a branded version of the pill, to women of all ages without a doctor’s prescription. Health and Human Services Secretary Kathleen Sebelius overruled the decision, marking the first time an FDA decision has been reversed by a presidential administration.

The agency last month approved over-the-counter sales of Plan B One-Step to girls as young as 15, saying its decision was “independent” of the court case and wasn’t intended to respond to the judge’s order. A generic version of the drug, Watson Laboratories Inc.’s Next Choice, is available without a prescription to women 17 or older, according a website for the drug.

Korman today said the change offered little additional benefit to women because they would still be subject to age restrictions, and the youngest would be able to only obtain Teva’s more expensive branded drug rather than generics.

No Review

The judge said he was unwilling to send the case back to the agency for further review, since Sebelius is unlikely to change her mind.

“There’s no way that this could be approved unless the secretary gets out of the way,” Korman told Amanat.

During the arguments, Korman sat at a long table in his courtroom with the lawyers, at times raising his voice and striking the table while speaking to Amanat.

Korman’s ruling expanded on a 2009 decision in which he ordered that the pill be made available without a prescription to women as young as 17. The judge said then that the age restrictions were arbitrary and based more on political pressure than safety.

The contraceptive, which contains a larger dose of the hormone levonorgestrel than found in other birth control pills, prevents pregnancy by inhibiting fertilization.

The drugs are most effective when taken within 24 hours of intercourse.

Administration Action

Sebelius in 2011 ordered the FDA to reject Teva’s application because of the “cognitive and behavioral” differences in girls of the youngest reproductive age.

“I think my own view of what I did will prevail in the court of appeals,” the judge told Amanat. “Is there a public interest in unwanted pregnancies, which could often result in abortion?”

The case is Tummino v. Hamburg, 12-cv-00763, U.S. District Court, Eastern District of New York (Brooklyn). The appeal is Tummino v. Hamburg, 13-1690, U.S. Court of Appeals for the Second Circuit (Manhattan).

To contact the reporter on this story: Christie Smythe in federal court in Brooklyn, New York, at csmythe1@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.

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