Published Online: Friday, September 1, 2006

Representatives of Mylan Laboratories called on Congress to step into the pharmaceutical marketplace to protect American consumers and taxpayers from a variety of anticompetitive practices that delay the availability of cost-saving generic drugs.

Testifying before the US Senate Special Committee on Aging, Mylan's Senior Vice President of Strategic Corporate Development Heather Bresch charged that "brand pharmaceutical companies are employing multiple tactics in order to delay or block consumer access to affordable pharmaceuticals."

In addition to the filing of frivolous citizens' petitions designed to create unwarranted delays in FDA approvals of generics, branded manufacturers also are misusing "authorized generics" to undermine the incentives for the development of truly competitive generic drugs, she charged.

Additionally, Bresch told the committee that "legal maneuvering around Congress's attempt to allow for a declaratory judgment trigger can create a bottleneck of generic drug approvals." Still another anti-generic drug tactic cited by the Mylan executive involves "exploitation of pediatric exclusivity rules to gain extended monopoly for drugs that should not be used in the pediatric population."

In calling for help from Congress to curb these anticompetitive activities, Bresch suggested that the first order of business should be legislation to prohibit the marketing of an authorized generic during the 180-day exclusivity period established by the Hatch-Waxman Act.

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