PHARMACY

GPhA ‘deeply disappointed’ with ‘pay-for-delay’ ban in Obama healthcare bill

BY Alaric DeArment

ARLINGTON, Va. President Barack Obama’s proposed healthcare bill may have its supporters and detractors, but one group unhappy about it is the generic drug industry.

The Generic Pharmaceutical Association criticized a part of the bill that would ban settlements between generic and brand drug companies in patent challenges, saying it would be costly to consumers.

“We are deeply disappointed that the administration has chosen to include measures to ban settlements of generic patent challenges in this renewed healthcare reform bill,” GPhA president and CEO Kathleen Jaeger stated.

The settlements, while decried by critics as “pay-for-delay” deals, are a common practice and currently legal. Seeking to market a generic version of a branded drug before the branded drug’s patent expires, a generic company will file an approval application with the Food and Drug Administration that includes a Paragraph IV certification, asserting that the patent is invalid, unenforceable or won’t be infringed. In virtually all cases, the brand drug maker will respond with a patent infringement lawsuit, which prevents the FDA from approving the generic drug for 30 months or until the matter is resolved before the court.

Often, the brand and generic company will reach a settlement, which can include anything from monetary payment by the brand company to an agreement not to launch an “authorized generic,” essentially the branded drug marketed under its generic name, in exchange for the generic company putting off entry into the market.

But in any case, Jaeger has told Drug Store News, the settlements usually allow the generic company to enter the market prior to patent expiration, in addition to the six months of market exclusivity that it gets when the patent expires; for the generic company to continue delaying entry after the patent had expired, Jaeger said, it would be illegal. According to analysis by the Royal Bank of Canada, in cases where patent challenges were litigated to their conclusion, generic drugs entered the market prior to patent expiration 48% of the time, versus 76% of the time when the brand and generic companies reached a settlement.

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FDA approves Menveo

BY Alaric DeArment

CAMBRIDGE, Mass. Novartis has received Food and Drug Administration approval for a vaccine for meningococcal disease, the Swiss drug maker’s vaccines division announced Monday.

The FDA approved Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197) to prevent meningococcal disease caused by Neisseria meningitidis bacteria.

 

The disease infects more than 500,000 people each year, killing as many as 1-in-7 who contract it; it is often fatal within 48 hours. About one-in-five who survive have serious side effects, including limb amputations, learning disabilities, seizures and paralysis.

 

 

“The FDA approval of Menveo is an important milestone for adolescent immunization in the United States,” Novartis vaccines division head Andrin Oswald said in a statement. “According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease.”

 

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Watson CEO to serve as GPhA chairman

BY Alaric DeArment

NAPLES, Fla. Watson Pharmaceuticals president and CEO Paul Bisaro will serve as the Generic Pharmaceutical Association’s chairman for 2010-2011, GPhA announced.

Bisaro has led Watson since 2007, after a stint as president and CEO of Barr Labs that began in 1999. He has served on GPhA’s board of directors since 2008, most recently as vice chairman.

“Paul will provide us with a steady hand as GPhA next navigates the often turbulent issues of health reform and the nation’s economic recovery,” GPhA president and CEO Kathleen Jaeger said. “GPhA looks forward to working with him, our board of directors and executive committee in what will be a challenging year.”

The organization also elected Mylan Pharmaceutical president Tony Mauro as vice chairman, New Chemic senior consultant Rosendo Ferran as secretary-treasurer. Nycomed U.S. CEO Paul McGarty, Teva North America president and CEO William Marth, Sandoz president and CEO Christine Mundkur and Zydus Pharmaceuticals president and CEO Joe Renner will serve as at-large members on the board’s executive committee.

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