Vidyya Medical News Service
Volume 6 Issue 185 Published - 14:00 UTC 08:00 EST 3-Jul-2004 Next Update - 14:00 UTC 08:00 EST 4-Jul-2004
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FDA supports broader access to lower priced drugs

The Food and Drug Administration (FDA) today issued responses to three Citizen Petitions. These agency decisions protect more rapid access to lower-priced prescription drugs.

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.

Today’s actions promise to advance broader, more rapid access to safe and effective prescription drugs for American consumers.

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