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Mylan COO says Congress must 'look further into use, abuse of authorized generics'


PITTSBURGH An executive from generic drug maker Mylan said in testimony before Congress Wednesday that “authorized generics” launched by brand drug makers during a generic company’s customary six months of market exclusivity undermine competition.

Testifying before the House Judiciary Subcommittee on Courts and Competition Policy, Mylan COO Heather Bresch also said authorized generics – branded drugs that brand companies release under their generic names, often through third-party companies – delay access to generic medications for patients, taxpayers, government agencies and businesses.

“When it comes to settlements, Congress need look no further than the use and abuse of authorized generics by brand manufacturers,” Bresch said in the hearing, which the subcommittee convened to debate so-called “pay-to-delay” agreements between brand and generic drug companies. “The increase in the number of patient litigation settlements in recent years is directly related to the increased use of authorized generics during the 180-day market exclusivity period.”

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