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NEW YORK — The emergency contraceptive Plan B (the original two-tablet formulation) can now be sold as an OTC without any sales restrictions as the Obama administration concedes its fight to prevent nonprescription access to younger teenage girls. And soon the newer Plan B One Step (one tablet) will be available without sales restrictions as well.
In a letter to Bonnie Scott Jones, special counsel to the Center for Reproductive Rights, the Food and Drug Administration announced it would comply with a court ruling that the emergency contraceptive Plan B (levonorgestrel) be made available as a nonprescription product without any placement or age restrictions.
Further, FDA shared that it has invited Teva Pharmaceuticals to submit a supplement to its application for Plan B One Step and has stated it will approve that supplement in short order. "FDA has indicated that the supplement can reference Teva's supplement submitted for Plan B One Step in February 2011," wrote Janet Woodcock, FDA director, Center for Drug Evaluation and Research. "FDA, in conformance with the court's order, intends to approve in a timely manner Plan B One Step as a nonprescription product available without point-of-sale or age restrictions."
After Teva's supplement is submitted and approved, FDA expects sponsors of the generic versions of Plan B One Step to submit amendments to their abbreviated new drug applications.
However, the government hasn't necessarily reversed its opposition to OTC availability of levonorgestrel products, noted Washington Post reporter Sarah Kliff in a Wonkblog published Tuesday.
Citing an executive-level source within the administration, Kliff suggested the administration realized it would likely lose its appeal on maintaining prescription-only status for the original two-pill formulation of Plan B. "According to the senior official, there was worry about the two-pill product proving too complex for young girls to use it properly," Kliff wrote. "The newer Plan B One-Step, which contains a one-pill dosage of levonorgesterl, is easier to use, which the administration thought made it a safer over-the-counter product."
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