The Obama administration will not fight the April 5 ruling of a federal judge that one-dose emergency contraception must be available for all ages without a prescription.
In a 2-page letter, the U.S. Department of Justice yesterday wrote to Judge Edward R. Korman of the Eastern District of New York that FDA and the U.S. Department of Health & Human Services has complied with Korman’s judgment by making Plan B One-Step (levonorgestrel—Teva) available OTC without age or point-of-sale restrictions.
Once the federal district court confirms that the government’s understanding is correct, the government intends to file notice that it is voluntarily withdrawing its appeal.
FDA yesterday invited Teva to submit a supplemental new drug application (SNDA) “with proposed labeling that would permit [Plan B One-Step] to be sold without a prescription and without age or point-of-sale restrictions,” according to the letter. The agency “will approve [the SNDA] without delay.”
After FDA approves Teva’s supplement, the agency expects sponsors of the generic versions of Plan B One-Step to submit appropriate amendments to their abbreviated new drug applications, the letter said. “If FDA grants Teva marketing exclusivity, the scope of that exclusivity may affect the labeling that could be approved for generic equivalents of” Plan B One-Step.
FDA will not change the approval status of the two-dose Plan B, according to the letter.
Previous coverage on pharmacist.com includes the following:
May 21, 2013: Obama administration appeals Plan B ruling
For more information, June Pharmacy Today includes articles on the role of the pharmacist in patient counseling on emergency contraception and increased access for emergency contraception.