Consumer Advocacy Groups, Pharmaceutical Companies Debate Three-Year Marketing Exclusivity Period Awarded By FDA For Plan B

Main Category: Cancer / Oncology
Also Included In: Women's Health / Gynecology;  Pediatrics / Children's Health
Article Date: 15 Nov 2006 - 17:00 PDT


Consumer advocates and drug companies are debating FDA's decision to grant Barr Pharmaceuticals three years of regulatory exclusivity for its emergency contraceptive Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse, the Boston Globe reports. In exchange for exclusivity -- in which the drug will receive no generic competition for a certain period of time -- Barr must conduct a series of studies to determine how consumers use the product and how they understand the new label. Melissa Dunn, a spokesperson for GlaxoSmithKline Consumer Healthcare, said exclusivity provides "some incentive for innovation," adding, "It's really for companies who are doing all of the background research, investing the [research and development] dollars, and time and efforts into developing a product to give them some protection for a period of time." GSK received three years of exclusivity for over-the-counter sales of the smoking cessation drug Nicorette. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the exclusivity means that consumers will have to pay more for the drug than they should, adding that pharmaceutical companies "should get some advantage for" their research, "but it seems like three years is on the long side." Democratic lawmakers, who will hold the majority in the 110th Congress, have said they will seek some restrictions in the methods drug makers use to keep generic competition off the market (Boston Globe, 11/13).

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