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Ruling clears obstacles judge said were politically influenced
A New York federal judge has struck down the restrictions on levonorgestrel-based emergency contraceptives and ordered the FDA to make the drugs available without a prescription and without point-of-sale or age restrictions within 30 days, according to an
U.S. District Judge Edward Korman in Brooklyn, N.Y., reversed the FDA decision that denied a Citizen Petition seeking to expand the availability of Plan B and all emergency contraceptives 12 years ago. In 2005, the plaintiffs, including organizations and individuals concerned about women’s health, filed a lawsuit against the FDA, stating that “the FDA’s denial of the Citizen Petition … was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making.”
In 2006, FDA approved Plan B as an over-the-counter drug for women 18 and older, and as a medication available by prescription for those younger than 18. In 2011, FDA conceded that Plan B could be made available to women 17 and older without a prescription. Now levonorgestrel-based emergency contraceptives are available for women 17 and older without a prescription, but the drugs can only be purchased at a pharmacy with a government-issued ID for proof of age.
“The obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription,” wrote Judge Korman in his memorandum.
In his written ruling, Judge Korman said that the decisions made by the secretary of the U.S. Department of Health and Human Services with respect to Plan B One-Step and by the FDA to deny the Citizen Petition with respect to availability of emergency contraceptives to patients of any age without a prescription “were arbitrary, capricious, and unreasonable.”
He said that the FDA’s decision was influenced by the Bush administration and that the HHS’ decision was influenced by the Obama administration. Both decisions should have been based on scientific evidence.
In 2003, an FDA advisory committee of outside experts voted 23 to 4 that Plan B be recommended for OTC sale without any age or point-of-sale restrictions. It also voted 27 to 1 that the study data from the Plan B sponsor “could be extrapolated from older age groups to younger ones.”
Judge Korman said that the FDA may decide if new labeling is necessary and may limit the OTC approval to the one-pill product.