Morning-After Pill to Be Sold to All Ages, U.S. Says
By Christie Smythe - Jun 11, 2013 12:01 AM ET
The U.S. government told a federal judge it would make a branded version of the morning-after pill available to all women over-the-counter without age restrictions.
The government said in a letter filed yesterday in federal court in Brooklyn, New York, that it granted a petition to make the branded version of the emergency contraception available without age or point-of-sale restrictions. The government has appealed U.S District Judge Edward R. Korman’s April ruling that women of all ages must be allowed to purchase any version of the pill without a prescription.
The Teva Pharmaceutical Industries Ltd.’s emergency contraceptive tablet is seen in this undated handout photo provided to the media on Dec. 7, 2011. Source: Teva Pharmaceutical Industries Ltd. via Bloomberg
“It is the government’s understanding that this course of action fully complies with the court’s judgment,” the government said in yesterday’s letter. The U.S. said it will drop its appeal “once the court confirms that the government’s understanding is correct.”
Under the plan outlined in the letter, the U.S. Food and Drug Administration will approve new labeling for Teva Pharmaceutical Industries Ltd.’s (TEVA) branded version of the pill, Plan B One-Step, allowing it to be sold over-the-counter. The government said Teva could be granted exclusive rights to sell the pill, possibly affecting whether generic equivalents could also be sold in the same manner.
“FDA will not at this time take steps to change the approval status of the two-pill Plan B or its generic equivalents,” the government’s lawyers, including F. Franklin Amanat and Brooklyn U.S. Attorney Loretta E. Lynch, wrote in the letter.
The government’s move followed a decision by the U.S. Court of Appeals in New York to delay part of Korman’s ruling while it’s under appeal.
In his ruling, Korman said the FDA kept restrictions on obtaining levonorgestrel-based emergency contraceptives without a prescription for political rather than scientific reasons.
Currently, the FDA allows women 17 and older to obtain generic and non-generic one and two-pill versions of the morning-after pill without a prescription. In April, the agency approved Teva’s application to sell Plan B One-Step over the counter to girls as young as 15.
Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s decision in December 2011 to approve sales of Plan B One-Step without a prescription. The action was the first time an FDA finding has been reversed by a presidential administration. Sebelius said at the time that her decision to overrule the agency was merited by “cognitive and behavioral” differences in girls of the youngest reproductive age.
Center for Reproductive Rights Chief Executive Officer Nancy Northup said in a statement yesterday that the group is “pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently.”
“But we will continue to fight for fair treatment for women who want and need more affordable options,” she said, referring to generics and two-pill versions.
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).
– Editors: Peter Blumberg, Michael Hytha
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