MYLAN SEEKS LAWS TO CURB ANTI-GENERIC DRUG SCHEMES

Representatives of Mylan Laboratoriescalled on Congress to step into the pharmaceuticalmarketplace to protect American consumersand taxpayers from a variety of anticompetitive practicesthat delay the availability of cost-saving generic drugs.

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

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

Additionally, Bresch told the committee that "legal maneuvering aroundCongress's attempt to allow for a declaratory judgment trigger can create a bottleneckof generic drug approvals." Still another anti-generic drug tactic cited by theMylan executive involves "exploitation of pediatric exclusivity rules to gain extendedmonopoly 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 prohibitthe marketing of an authorized generic during the 180-day exclusivity periodestablished by the Hatch-Waxman Act.