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New England Journal of Medicine Perspective Calls Upon President Obama to Encourage Congress to Adopt Exclusivity Periods for Biopharmaceuticals Similar to Those in Hatch-Waxman Act

ARLINGTON, VA, OCTOBER 15, 2009 – The following is a statement from GPhA President and CEO Kathleen Jaeger on the New England Journal of Medicine article, “Balancing Innovation, Access and Profits – Market Exclusivity for Biologics”:

“The prestigious New England Journal of Medicine article endorses the proven Hatch-Waxman model for exclusivity. The article is further evidence of the growing scientific and economic case rejecting the unprecedented and excessive market exclusivity periods currently contained in the House and Senate biogeneric bills. The distinguished authors conclude that Congress must revisit the issue of exclusivity, and called upon the President to encourage amendments that would give the FDA the mandate to evaluate and approve affordable biosimilar and biogeneric drugs, while also adopting an effective Waxman-Hatch market exclusivity paradigm that will foster brand innovation.

“The authors go on to say that ‘such a compromise would best balance the need for financial incentives with the need for competition, promoting access and motivating important subsequent innovation.’ They point to the fact that for the last 25 years, the Hatch-Waxman Act has successfully achieved the goal of fostering innovation while also providing affordable medicines to consumers.

“As the House Energy and Commerce Committee Chairman Waxman said last month, the ‘war is not over’ in the fight for affordable biogenerics. This article makes a strong and compelling case against the existing bills, which put brand pharmaceutical company profits ahead of patient needs. There is still time for Congress to get this right. President Obama has already put forth a reasonable compromise of seven years of market exclusivity to help move this debate forward. For the sake of patients searching for affordable life-saving medicines, it is incumbent upon Congress to listen to the President and put patients first.”

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 72% of the total prescriptions dispensed in the United States, but only 17% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.

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