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Shots - Health News
Thu June 13, 2013
Judge Reluctantly Approves Government Plan For Morning-After Pill
Originally published on Thu June 13, 2013 2:11 pm
An obviously unhappy Judge Edward Korman has approved the Obama administration's proposal to make just one formulation of the morning-after birth control pill available over the counter without age restrictions.
But in a testily worded six-page memorandum, the federal district judge made it clear he is not particularly pleased with the outcome. He has been overseeing the case in one way or another for more than eight years.
The deal, Korman wrote in his Wednesday night memorandum, makes it likely that the version called Plan B One-Step will for now be the only product available on retail shelves. That's even though it is the most expensive, at a cost of between $40 and $50. The deal proposed by the administration, he wrote, "confers a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and less accessible to many poor women."
Late Monday, the administration said it would drop its appeal of Korman's April ruling that would have made all products using the hormone levonorgestrel available within 30 days without age or prescription restrictions.
Up to that point the products, mostly sold under the "Plan B" label, were available to those age 17 and over without a prescription, but were kept behind the pharmacy shelf. Younger teens still needed a prescription. And those old enough not to need a prescription could obtain the products only when a pharmacy was open. They also had to request them, and show proof of age.
On April 30, just days before the judge's deadline, the FDA proposed what appeared to be a compromise. It approved a new label for Plan B One-Step that would make it available on pharmacy shelves, rather than behind the counter. But it would still require a prescription for those younger than 15. And the agency appealed Korman's ruling.
But when the Justice Department asked Korman for a stay of his ruling while it appealed, he said not only said no but excoriated the government for behavior he called "something out of an alternate reality."
It was a surprise last week when a panel of the federal 2nd Circuit Court of Appeals also denied a stay of Korman's ruling, at least in part. The appeals court would have required that generic two-pill versions of the emergency contraceptive pills be made immediately available.
That signaled that the government was not likely to succeed in its appeal and led to Monday's proposal. But the idea that only Plan B One-Step, and not any of its generic equivalents, would be immediately available made the plaintiffs in the lawsuit very unhappy.
"Exclusive over-the-counter access to a single pharmaceutical company will allow for exorbitant monopoly prices, placing emergency contraception financially out of reach of millions of women and girls," said Mara Verheyden-Hilliard, executive director of the Partnership for Civil Justice Fund, which brought the original lawsuit. "Imposing unjust financial barriers to access sacrifices the rights of millions of poor and young women solely to benefit a pharmaceutical company."
In his memo, Korman urged the FDA not to grant additional "exclusivity" to Teva Pharmaceuticals, the patent owner of Plan B One-Step, even though the company conducted a study that under drug law should make it eligible for protection from generic competition.
"Whatever expense Teva incurred, it did not mount a legal challenge to the FDA's denial" of its original request to allow the drug to be sold without age restrictions in 2011, Korman wrote. "Instead, it entered into an agreement with the FDA which allowed it to market Plan B One-Step to women 15 and over, thus leaving in place burdensome point-of-sale and photo identification requirements."
Korman also made it clear that if the FDA does not act "without delay" to approve Plan B One-Step without age restrictions, as it promised, "the plaintiffs will have a remedy available." Presumably meaning they could go back to court.