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NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma's behalf in extending patent exclusivity for Plan B One-Step.
Korman is the same district judge who in 2009 ruled that the decision whether to make Plan B One-Step available without a prescription regardless of age "was one that should be made by the FDA, to which Congress had entrusted the responsibility, and not by a federal district judge." Instead he ruled, at the time, that the FDA reconsider a Citizen's Petition to make Plan B available to women of all ages.
Three years later, FDA commissioner Margaret Hamburg issued a statement supporting Plan B One-Step availability to all ages, however ruling was subsequently overruled by Department of Health and Human Services Secretary Kathleen Sebelius. "The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious and unreasonable," Korman ruled in his 59-page decision.
"The standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug 'safely and effectively,'" he wrote. "I decide this case based only on my understanding of the applicable standard."
In his second ruling, Korman ruled the district court did not have jurisdiction to compel the agency. "I have no power to grant a period of exclusivity," he noted. "Indeed, I do not have subject matter jurisdiction to review the denial of Teva’s NDA for the purpose of granting it any relief, much less granting a period of exclusivity that only the FDA can grant when it approves an application after finding that the studies submitted by the sponsor are essential. Under these circumstances, intervention would be pointless."
The ruling to expand availability to women under the age of 17 also potentially applies to Plan B and the generic equivalent levonorgestrel, though the judge allowed for the FDA to determine whether to restrict the decision to Plan B One-Step. "If the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product," Korman ruled.
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