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FDA Contests Court Intervention On Plan B As Teva Argues For Exclusivity

This article was originally published in The Tan Sheet

Executive Summary

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.

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Court Ruling Compels Emergency Contraceptives Over The Counter

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.

Court Ruling Compels Emergency Contraceptives Over The Counter

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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