Judge Edward Korman of the Eastern District of New York gave no quarter to the Administration in his ruling this morning declining to issue a stay to his April ruling that made emergency contraceptives available over the counter pending the outcome of the Administration’s appeal. Korman not only repeated his assertions that the Administration was acting in bad faith by trying to dictate the terms of women’s access to Plan B for political reasons, but noted that the deal it struck with one manufacturer to keep it out of the lawsuit would serve to drive up prices to that manufacturer’s certain benefit.
In a ruling filled with harsh language for the government — he called their arguments “silly,” “something out of an alternative reality ” an “an insult to the intelligence of women” and “frivolous” and referred to Sebelius’ conduct “improper” — Korman noted that the supposed concerns for the well-being of younger potential users of emergency contraceptives were “a red herring to justify the continued burdens suffered by older women who seek access to the drug.” He also stated that the agency’s argument that the stay was necessary to preserve public confidence in the FDA’s decisions was paradoxical on its face because it was Sebelius’ order overturning the FDA’s decision that started the case: “If a stay is denied, the public can have confidence that the FDA’s judgment is being vindicated, and if a stay is granted, it will allow the bad-faith, politically motivated decision of Secretary Sebelius, who lacks any medical or scientific expertise, to prevail—thus justifiably undermining the public’s confidence in the drug approval process.”
Korman, whose April 5, 2013 decision directed the FDA and Health and Human Services Secretary Kathleen Sebelius to make emergency contraceptives available over the counter regardless of the manufacturer, was issued in response to a Citizen Petition requesting the action. That petition was filed after Sebelius rejected an application by emergency contraceptive manufacturer Teva Women’s Health to market their product over the counter — an application that had initially been approved by the Food and Drug Administration. Korman ruled that the decision to deny the Citizen Petition was “politically motivated, scientifically unjustified, and contrary to agency precedent.” But, he wrote, the decision in April was not limited to Teva, which manufactures the brand-name emergency contraceptive “Plan B” and had not sued for a reversal of the Secretary’s decision. Instead, it applied to all levonorgestrel-based emergency contraceptives. (Korman did leave room for the FDA to approve only one-pill variants of levonorgestrel-based emergency contraceptives in his decision, which had been the FDA’s first decision, though the suit called for both varieties to be made available over the counter.)
The Administration’s request for a stay argued that, without that stay pending appeal, they would suffer “irreparable injury” because on April 30, 2012 — the day before filing their appeal — the agency struck a deal with Teva based on a proposal Teva made to the FDA in March 2012. That proposal was to make Teva’s Plan B available at any retail outlet with an in-store pharmacy to women over the age of 15, and to prohibit its sale to women under 15 entirely. The discussions, said Korman in his ruling, went fallow after June 2012 until Korman’s advised HHS in March 2013 that he planned to issue a ruling that observers widely expected would not be in HHS’s favor. At that point, FDA (which is part of HHS) re-entered negotiations with Teva, resulting in their April 30, 2012 agreement.
Korman noted that, if he stayed his own ruling pending appeal, the FDA agreement with Teva would actually be widely in Teva’s economic favor: it provides that Teva’s Plan B — and only that drug — can be sold over the counter in a store with an on-site pharmacy, and that even if a woman preferred a different option, she wouldn’t be able to access it if the pharmacy was closed. Women under the age of 15 wouldn’t be able to access Plan B at all, or any other emergency contraceptive without a prescription. In addition, the agreement allows Teva to market its Plan B to 15- and 16-year-olds exclusively for three years, as it would be the only emergency contraceptive available to them that would not be behind the pharmacy counter — a plan with includes Plan B’s generic competitors. Korman called the proposal a “boon” to Teva, who would lose little revenue by agreeing not to sell to women under the age of 15 because 99 percent of its sales are already to women older than 15.
Korman additionally wrote that Teva’s Plan B would rise in price to at least $60 because of its exclusivity clauses, and might go higher because of the safeguards they would need to implement to abide by its agreement not to sell or market to women under 15 years old. The rise in cost would further restrict its access to only those women who could afford it, which Korman said in his ruling meant the plaintiffs, not the government, would experience more irreparable harm. Further, he noted that poor women and African-American women were significantly less likely to have government-issued photo identification, which would limit even further their access to emergency contraceptives over the counter.
Korman’s ruling also underlined one source of his apparent ire at the Administration: the fact that the FDA decision on over the counter access has been pending for twelve years and he has already remanded the case back to the Administration to no effect. “In my 2009 opinion, after concluding that the administrative agency process was corrupted by political interference, I declined the plaintiffs’ request to avoid a remand and simply direct that the FDA award them the relief that they sought,” he wrote. At the time, he added, “A new FDA Commissioner, Deputy Commissioner, and President had come into office since the agency’s decision on Plan B had been made, who I thought could be ‘trusted to conduct a fair assessment of the scientific evidence.'” That, he said, is no longer the case: “On remand, defendants engaged in the same bad faith that resulted in my initial remand. They delayed the decision for three years and, ultimately, improper political influence prevented the FDA from granting the petition.”
Nancy Northup, the president and CEO for the Center for Reproductive Rights, said in a statement, “Today science has finally prevailed over politics.” However, Korman did stay his ruling until Monday, May 13, 2013 — to allow the government to file to an appeals court for a stay to his ruling.
[Image courtesy of the Department of Health and Human Services on Flickr]