News from the FDA

The FDA issued responses to three Citizen Petitions last month, the cumulative effects of which will promote earlier access to lower-priced prescription drugs. In one action, the FDA denied petitions submitted by Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc. seeking to prohibit the marketing and distribution of reduced-price “authorized generic” versions of brand-name products during 180-day exclusivity periods. The agency also denied a petition submitted by Pfizer Inc., seeking to prevent generic applicants' waiver of 180-day exclusivity. In announcing these actions, the Agency stated that allowing eligible generic applicants to waive the exclusivity promotes competition by enabling other generic applicants to market their products sooner, and the agency could see “no reason to interfere with the marketing of authorized generics and waiving 180-day exclusivity, two long-standing, pro-competitive business practices.”