The US Food and Drug Administration (FDA) issued responses to three citizen petitions. These agency decisions protect more rapid access to lower-priced prescription drugs, an FDA release said.
In one action, 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, which enable the first generic applicants that challenge patents potentially blocking their products to market these products six months earlier than other generic applicants.
Marketing of authorized generics increases competition, promoting lower prices for pharmaceuticals, particularly during the 180-day exclusivity period in which the prices for generic drugs are often substantially higher than after other generic products are able to enter the market.
The agency also denied a petition submitted by Pfizer Inc, seeking to prevent generic applicants' waiver of 180-day exclusivity. Allowing eligible generic applicants to waive the exclusivity promotes competition by enabling other generic applicants to market their products sooner.
FDA's mission is protection and promotion of public health and does not generally call for review of the business dealings of drug manufacturers. FDA sees no reason to interfere with the marketing of authorized generics and waiving 180-day exclusivity, two long-standing, pro-competitive business practices, the release says.