Women’s health groups gave measured praise to the U.S. government’s proposal to make a branded version of the morning-after pill available over the counter without age restrictions, expressing concern that cheaper generics may still be kept behind the counter.
The U.S. said in a letter filed yesterday in federal court in Brooklyn, New York, that it granted a petition to make Teva Pharmaceutical Industries Ltd. (TEVA)’s Plan B One-Step emergency contraceptive available without age or point-of-sale restrictions.
The announcement came as the Obama administration was appealing 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. Susannah Baruch, interim president and chief executive officer of the Reproductive Health Technologies Project, called yesterday’s letter “fantastic news.”
“There are still a few questions left to answer,” Baruch said on a conference call today. “We are concerned that the administration hints they may give exclusivity to the marketing for Plan B One-Step. This is not a minor issue.” She said the branded pill costs as much as $50 a dose.
Under the plan outlined in the letter, the U.S. Food and Drug Administration would approve new labeling for 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.
“It is the government’s understanding that this course of action fully complies with the court’s judgment,” lawyers for the government, F. Franklin Amanat and Brooklyn U.S. Attorney Loretta E. Lynch, said in the letter. The U.S. said it will drop its appeal “once the court confirms that the government’s understanding is correct.”
The government said it won’t “at this time” seek to change the status of older two-pill versions of the emergency contraceptive or its generic equivalents. On June 5, the U.S. Court of Appeals in Manhattan agreed to delay part of Korman’s ruling while it was under appeal. The appeals court didn’t impose a delay on the two-pill version, saying that the government failed to meet the requisite standard for a stay.
“The administration finally saw that it had nowhere else to go,” Baruch said today. In yesterday’s letter, “the administration sounds a little bit like a kid who knows he’s in trouble,” and trying to negotiate “to see if he can get a little bit more.”
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.
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.
The most recent legal challenge arose after 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.
In his ruling, Korman said the FDA kept restrictions on obtaining levonorgestrel-based emergency contraceptives without a prescription for political rather than scientific reasons.
At a hearing in May, Korman also criticized the government’s move to sell Plan B One-Step to girls as young as 15, saying that it was unfair to allow younger teens to purchase only the more expensive branded drug without a prescription. Korman also said the age restrictions could prevent some women from obtaining the pills if they lack photo identification.
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.
Korman hasn’t yet responded to the government’s letter. Women’s health group representatives said today that they weren’t sure what would happen if Korman doesn’t agree to the government’s proposal. Amanat, the lawyer for the government, declined to comment.
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.”
Planned Parenthood Federation of America President Cecile Richards called the proposal “a huge breakthrough” in a statement yesterday.
“The FDA’s decision will make emergency contraception available on store shelves, just like condoms, and women of all ages will be able to get it quickly in order to prevent unintended pregnancy,” she said.
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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