Judge Won’t Stay Order Expanding Plan B Access

     (CN) – Calling the government’s arguments “an insult to the intelligence of women,” a federal judge on Friday declined to stay his order requiring over-the-counter access to emergency contraceptives regardless of age.
     U.S. District Judge Edward Korman in Brooklyn, N.Y., said the Obama administration’s appeal of his April 5 order “is frivolous and taken for the purpose of delay.”
     However, he gave the government until Monday to file a motion to stay in the 2nd Circuit “as a courtesy” to the federal appeals court.
     In last month’s decision, Korman ordered the Food and Drug Administration to “make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions.”
     He based that ruling on the FDA’s own finding that Plan B One-Step — the one-pill version of Plan B, or the “morning-after” pill — “is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”
     Plan B and Plan B One-Step are emergency contraceptives that use the synthetic hormone levonorgestrel to mimic the naturally occurring hormone progesterone as a way to interfere “with prefertilization events,” according to Korman’s earlier ruling.
     Though Plan B is no longer marketed, generic versions are available. The FDA approved them for use by women 17 and older without a prescription if they can prove their age with a government-issued photo ID.
     The FDA announced last week that Plan B One-Step could be sold to those 15 and older, but only in stores with an on-site pharmacy.
     Korman noted that the effort to expand over-the-counter access to the drugs has been underway for more than a decade, “even though they would be among the safest drugs available to children and adults on any drugstore shelf.”
     On remand, the FDA dragged its feet but ultimately approved over-the-counter access to Plan B One-Step for all ages.
     But before that could happen, Kathleen Sebelius, secretary of the Department of Health and Human Services, reversed the FDA’s decision – a move Korman said was “politically motivated, scientifically unjustified, and contrary to agency precedent.”
     Mara Verheyden-Hilliard, executive director of the Partnership for Civil Justice Fund, agreed with that assessment.
     “President Obama is seeking to sacrifice the reproductive rights of women of all ages at the altar of his political strategy,” she said in a statement. “He wants to placate the political right wing at the expense of the health needs and reproductive rights of women.”
     Five days after the administration intervened, the FDA rejected a citizen petition seeking unrestricted over-the-counter status for Plan B and its equivalents.
     In Friday’s ruling, Korman said the FDA continued its “administrative agency filibuster” by appealing his decision, “possibly for the purpose of further delaying greater access to emergency contraceptives for purely political reasons.”
     He rejected as “silly” the government’s claim that a stay was needed to “prevent public uncertainty” about the status of the pills.
     The government had claimed that “if the status of these drugs is changed and later reversed, it can lead to situations in which women mistakenly believe that they can obtain the drug without a prescription or at certain locations where it used to be available, but is no longer.”
     “This argument … is largely an insult to the intelligence of women,” Korman wrote in his 17-page order. “If women can no longer obtain Plan B without a prescription at certain locations, they will go to locations where it is available.”
     Any confusion or uncertainty about the drugs’ status is rooted in the government’s actions, not the court’s, Korman added.
     He also rejected the administration’s claim that a stay won’t injure the citizen plaintiffs because they’re all over 15 and will soon be able to buy at least one version of the pill without a prescription.
     But Korman said the government failed to consider the fact that requiring customers to prove their age using a government-issued photo ID “constitutes a substantial impediment” for minorities and poor adults.
     He added that the focus on younger adolescents in the public debate is mostly “a red herring to justify the continued burden suffered by older women who seek access to the drug.”
     Korman said a simple remand would be futile in this case, because the Obama administration has not changed its position.
     “The FDA is not the problem,” he concluded. “The cause of the rejection of over-the-counter sale of levonorgestrel-based emergency contraceptives was the Secretary of Health and Human Services.”

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