Court Ruling Compels Emergency Contraceptives Over The Counter
This article was originally published in The Pink Sheet Daily
Under a federal judge’s order, FDA must reverse its denial of the Center for Reproductive Rights’ 12-year-old citizen petition and allow universal OTC access to Plan B One-Step and equivalent levonorgestrel-based emergency contraceptives within 30 days.
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The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics recommend OTC availability of hormonal contraception, but pharmaceutical industry Rx-to-OTC switch sponsors remain elusive.
A federal judge seems inclined to order FDA to make emergency contraceptives available OTC to women younger than 17, but he did not say whether the use would be limited to Teva’s Plan B One-Step, or would include all nonprescription levonorgestrel products.
In CRR’s lawsuit, FDA and Teva argue that the firm’s potential for OTC market exclusivity for Plan B One-Step should be protected. But while Teva is open to judicial intervention on whether to allow universal OTC sales, FDA says precedent supports judicial deference to agency scientific decisions.