Obama Offer on Morning-After Pill Falls Short, Groups Say

The Obama administration’s proposal to let a branded version of the morning-after pill be sold over the counter without restrictions is sufficient to meet the terms of a court order mandating expanded access to the contraceptive, a federal judge said.

U.S District Judge Edward R. Korman in Brooklyn, New York, filed his comments on the government’s offer yesterday. Under the plan, proposed earlier this week, the government said it would allow Teva Pharmaceutical Industries Ltd. to sell its Plan B One-Step to all women without a prescription. Generics and older two-pill versions of the drug could remain behind the counter.

“The government’s understanding of my order is not quite correct, although I do not regard any inconsistency with my order as significant,” Korman said in yesterday’s memorandum. “I did not order the defendants to make the brand-name Plan B One-Step available over-the-counter without age or point-of-sale restrictions.”

The judge’s filing is the latest development in a long-standing court battle over broadening access to the emergency contraceptive. In an April ruling, Korman chastised the government for delaying approval of over-the-counter sales of the drug, which was considered safe by the U.S. Food and Drug Administration. He ordered the government to make all versions of the pill immediately available, without age limits, on pharmacy shelves.

Lawyers for the government said in a letter this week that they would drop an appeal of Korman’s April ruling if he agreed that the new proposal complied with his directives.

‘Sufficient’ Compliance

Granting an application “submitted by Teva and other off-brand manufacturers will have the effect of making it available without a prescription or point-of-sale or age restrictions,” Korman said. “This is sufficient to comply with my order.”

Korman urged the FDA to scrutinize any request by Teva for exclusive rights to sell the drug over the counter, a move that would bar similar sales of generics.

“A three-year grant of market exclusivity will only burden poor women,” he said. Women’s healthcare advocates say the branded pill costs as much as $50 per dose, with generics usually costing about $10 to $20 less.

The Center for Reproductive Rights and other advocacy groups filed a letter yesterday with the court objecting to the government’s proposal “because it does not entail the removal of unjustified age or point-of-sale restrictions for all products, including more affordable options.”

Eight Years

Women’s health groups have spent more than eight years in legal disputes with the government to expand over-the-counter access to levonorgestrel-based emergency contraceptives. In April, Korman said the FDA kept restrictions on obtaining the pills without a prescription for political rather than scientific reasons.

The most recent legal challenge arose after Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s December 2011 decision to approve sales of Plan B One-Step without a prescription. The action was the first time an administration has reversed an FDA finding, which Sebelius said was merited by “cognitive and behavioral” differences in girls of the youngest reproductive age.

The FDA allows women 17 and older to obtain generic and non-generic one- and two-pill versions of the contraceptive without a prescription. In April, the agency approved Petach Tikva, Israel-based Teva’s application to sell Plan B One-Step over the counter to girls as young as 15.

A lawyer for the government, F. Franklin Amanat, didn’t immediately return a call for comment on the judge’s filing.

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).

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