PHARMACY

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

BY Alaric DeArment

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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PHARMACY

Par ships first generic version of J&J drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. Par Pharmaceutical Cos. has begun shipping its generic version of a drug used to treat schizophrenia and bipolar disorder.

The company announced Tuesday the shipment of risperidone ODT in the 0.25-mg, 3-mg and 4-mg strengths. The drug is used in adults as a stand-alone treatment for schizophrenia and as a combination, with lithium or valproate, for the treatment of manic and mixed episodes in bipolar I disorder.

The drug is a generic version of Johnson & Johnson’s Risperdal M-TAB, which had sales of $89 million last year, according to IMS Health data. As the first company to file an approval application with a paragraph IV certification, Par has six months of market exclusivity, though J&J retains exclusivity for the use of the drug in children.

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FDA creates transparency taskforce

BY Alaric DeArment

ROCKVILLE, Md. After years of criticism, the Food and Drug Administration wants to take the tinting off its windows.

The agency announced Tuesday the creation of an internal transparency taskforce, headed by principal deputy commissioner Joshua Sharfstein, to find ways to make its decision making more transparent for the public while protecting confidentiality.

“Over the years, there have been complaints made about the FDA’s lack of transparency,” commissioner Margaret Hamburg said in a conference call with reporters Tuesday morning.

Hamburg said the taskforce would take comments from the public and stakeholders to find ways to make information about agency operations, recall information, enforcement and other activities more accessible. The agency will convene a public meeting on June 24 and another one in the fall and accept public comment through a docket until Aug. 7.

“The recommendations of the taskforce will allow us to more effectively implement the agency’s public health mission,” Hamburg said.

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