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GPhA Statement on Introduction of H.R. 1548, “The Pathway for Biosimilars Act”

Arlington, VA, March 17, 2009 – The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding the introduction of H.R. 1548, “The Pathway for Biosimilars Act.”

“The Pathway for Biosimilars Act is the wrong road for patients looking for safe and affordable biogeneric medicines, particularly during these difficult economic times. It is a long route filled with needless roadblocks that will keep patients from getting needed medicines in a timely manner.

“To increase competition and ensure timely patient access, Congress needs to enact a workable pathway without unnecessary barriers. The bipartisan consensus bill, the Promoting Innovation and Access to Lifesaving Medicine Act, introduced last week achieves the balance of fostering pharmaceutical innovation while also making affordable medicines available 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.

“That’s why consumer, business and labor organizations, AARP and many of our nation’s governors support the Promoting Innovation and Access to Lifesaving Medicine Act 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.

“Unfortunately, The Pathway for Biosimilars Act is the wrong medicine for patients and our nation’s health care system. This bill will only benefit brand companies by erecting barriers including an unprecedented and unjustifiable 14 years of market exclusivity. Given that there is a minimal difference of less than eight months longer in the development of biopharmaceuticals when compared to traditional pharmaceuticals, there is little justification for excessively expanding exclusivity beyond the Hatch-Waxman model. Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines. For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option.

“Timely access to affordable biogenerics will save lives and save consumers and state and federal governments billions of dollars. The time has come for a truly workable pathway, not a pathway in name only.”

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 about the industry, visit www.gphaonline.org.

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