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GPhA Statement on the Introduction of the Bipartisan Biogenerics Consensus Bill: “Promoting Innovation and Access to Life-Saving Medicine Act”

Hails Legislation as Pro-Patient and Pro-Pharmaceutical Innovation

Arlington, VA, March 11, 2009 – The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding the introduction of H.R. 1427, the Bipartisan Biogenerics Consensus Bill: “Promoting Innovation and Access to Life-Saving Medicine Act.”

“For the countless patients who are unable to afford the biopharmaceutical medicines they desperately need, today’s bipartisan introduction of the ‘Promoting Access to Life-Saving Medicine Act’ provides great hope that they will soon be able to obtain high quality care at more affordable costs. We applaud Chairman Henry Waxman (D-CA) and Rep. Nathan Deal (R-GA), Rep. Frank Pallone (D-NJ) and Rep. Jo Ann Emerson (R-MO) for working together to introduce this consensus bill that achieves the balance of fostering pharmaceutical innovation while also making affordable medicines available to consumers. And we look forward to the bipartisan introduction of a companion bill in the Senate in the near future.

“As our nation acts to strengthen our health care system, our priority must be to reduce costs while increasing access to quality care. Studies continue to show that creating a workable biogenerics approval pathway will not only bring life-saving medicines to patients in need, it will also save our health care system billions of dollars.

“That’s why consumer, business and labor organizations, AARP and many of our nation’s governors support legislation that brings biogeneric medicines to consumers sooner rather than later through timely resolution of patent disputes and market exclusivity provisions consistent with the Hatch-Waxman model. Over the past two years, members of Congress have learned a great deal about biogenerics. They’ve heard from the FDA that the science exists to approve safe, effective and affordable biogenerics. They’ve heard that the FDA scientists want the authority and flexibility to determine how to best ensure safety and efficacy. And they’ve heard that significant cost savings will result from bringing biogenerics to consumers.

“This bipartisan bill recognizes our health care system’s successful experience with generic medicines for the past 25 years. The market exclusivity provisions in Hatch-Waxman have clearly demonstrated that we can achieve the much-needed balance between pharmaceutical competition and innovation for the benefit of consumers, payors and state and federal governments. We’ve done it before with generics and we can do it again with biogenerics.

“Now, it’s time for action. Now, more than ever, it’s time to put patients first.
“During these difficult economic times, there must be increased urgency to support solutions that strengthen health care while reducing costs. ‘The Promoting Innovation and Access to Life-Saving Medicine Act’ is the right solution for high quality care at affordable costs.”

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 69% of the total prescriptions dispensed in the United States, but only 16% of all dollars spent on prescription drugs. For more information on biogenerics, please log on to www.gphaonline.org

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