Plan B One-Step OTC Proposal Leaves Plaintiffs, Judge Korman Wary

The Center for Reproductive Rights and other plaintiffs suing FDA say the agency’s plan to approve only Teva’s Plan B One-Step for universal OTC sales, but not less-expensive generic emergency contraceptives, would not provide sufficient access for all women.

The Center for Reproductive Rights and other women’s health care advocates will continue pressuring FDA to approve full OTC sales of all levonorgestrel-based emergency contraception, unsatisfied with a legal victory that clears a path for universal OTC access to just Plan B One-Step.

The Department of Justice, representing FDA in litigation over OTC access to emergency contraception, agreed in a June 10 letter to allow Teva Pharmaceutical Industries Ltd.’s Plan...

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