Emergency contraceptives

Plan B maker Women's Capital Corp. met with FDA Feb. 5 to present label comprehension, actual use study protocols for upcoming NDA to switch progestin-only product OTC. Actual use data will be based on Washington state and San Francisco Bay-area pilot programs, recently approved British Columbia OTC use (1"The Tan Sheet" Dec. 18, 2000, p. 3). Company also attempting to attain information gathered by U.K., French governments. Firm expects approval next year for the drug, the Rx exclusivity of which expires this July, but concedes changes to study protocols could delay process. Center for Reproductive Law & Policy to submit citizen petition requesting OTC access to ECs the week of Feb. 12