Judge Denies FDA Motion To Dismiss Plan B Lawsuit
This article was originally published in The Tan Sheet
A federal court has denied a motion by FDA to dismiss a lawsuit claiming the agency has "unreasonably delayed" a decision on Barr Labs' switch application for Plan B
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Reports from FDA officials vary as to the timing of the decision not to approve Barr's emergency contraceptive Plan B for over-the-counter sale, GAO's investigation into the application process reveals (see chart: "1Brief Timeline of Major Plan B Events Related to the Initial OTC Switch Application").
FDA received a dual Rx/OTC marketing plan from Barr for its emergency contraceptive Plan B several weeks before issuing a "not approvable" letter last spring, an internal agency memorandum reveals