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After the Kennedy-Enzi Committee Hearing, A Word from GPhA

March 8, 2007

Statement from Kathleen Jaeger, President and CEO of GPhA on Senate Health, Education, Labor and Pensions Committee Hearing on Biogenerics "On behalf of the Generic Pharmaceutical Association (GPhA), I thank Senators Kennedy and Enzi for holding this important hearing on biogenerics. American consumers and patients deserve to have this critical public health issue debated in the halls of Congress. "Biogenerics hold great promise for millions of Americans, but that promise will not be fulfilled without Congressional action. The FDA says it needs Congressional authority to create a clear, efficient abbreviated approval pathway to bring safe and effective biogenerics to consumers. The Access to Life-Saving Medicine Act will give FDA this authority and also provide it with the flexibility to let sound science drive the process to ensure safety. Safety must and will always be our number one priority. "There have been discussions on applying other nation's models to the U.S. While it is useful to examine and apply the positive and negative lessons learned from other nations that have entered into the generic biopharmaceutical market, we must take into account the uniqueness of the U.S. health care market. In exploring models to create a truly clear, efficient abbreviated approval pathway, the U.S. should be guided by the following four principles: ensuring interchangeability; ensuring safety and efficiency that brings biogenerics to consumers in a timely fashion; promoting sound science that encompasses scientific and technological advances; and fostering a robust competitive pro-consumer generic market. The Access to Life-Saving Medicine Act is the best pathway to increase access, foster competition, promote sound science and ensure safety. "Momentum is clearly growing for biogenerics as more and more Americans understand the true promise they hold. Nearly 50 organizations representing tens of millions of Americans ranging from the AARP to major corporations like GM and Caterpillar to our nation's leading consumer, patients and union groups are joining the call for safe, effective and affordable biogenerics. They know the opposition is strong, they've faced them before. However, they are united in their belief that this fight is too important to delay. As working families, employers and health plans look for ways to reduce health care costs without jeopardizing quality care, they are demanding generics and a pathway for biogenerics. "In 1984, brand companies said that generics would stifle innovation. It didn't happen. They said public health would be jeopardized. It didn't happen. They said the elderly and poor would be harmed. It didn't happen. In fact, more than half of Americans are now filling their prescriptions with safe, effective and affordable generics. Playing the scare card didn't work in 1984 and it won't work in 2007. Brand companies simply want to protect their monopolies. We need competition in the marketplace to increase consumer access and foster incentives for innovation."

pharmamanufacturing

Statement from Kathleen Jaeger, President and CEO of GPhA on Senate Health, Education, Labor and Pensions Committee Hearing on Biogenerics "On behalf of the Generic Pharmaceutical Association (GPhA), I thank Senators Kennedy and Enzi for holding this important hearing on biogenerics. American consumers and patients deserve to have this critical public health issue debated in the halls of Congress."Biogenerics hold great promise for millions of Americans, but that promise will not be fulfilled without Congressional action. The FDA says it needs Congressional authority to create a clear, efficient abbreviated approval pathway to bring safe and effective biogenerics to consumers. The Access to Life-Saving Medicine Act will give FDA this authority and also provide it with the flexibility to let sound science drive the process to ensure safety. Safety must and will always be our number one priority."There have been discussions on applying other nation's models to the U.S. While it is useful to examine and apply the positive and negative lessons learned from other nations that have entered into the generic biopharmaceutical market, we must take into account the uniqueness of the U.S. health care market. In exploring models to create a truly clear, efficient abbreviated approval pathway, the U.S. should be guided by the following four principles: ensuring interchangeability; ensuring safety and efficiency that brings biogenerics to consumers in a timely fashion; promoting sound science that encompasses scientific and technological advances; and fostering a robust competitive pro-consumer generic market. The Access to Life-Saving Medicine Act is the best pathway to increase access, foster competition, promote sound science and ensure safety."Momentum is clearly growing for biogenerics as more and more Americans understand the true promise they hold. Nearly 50 organizations representing tens of millions of Americans ranging from the AARP to major corporations like GM and Caterpillar to our nation's leading consumer, patients and union groups are joining the call for safe, effective and affordable biogenerics. They know the opposition is strong, they've faced them before. However, they are united in their belief that this fight is too important to delay. As working families, employers and health plans look for ways to reduce health care costs without jeopardizing quality care, they are demanding generics and a pathway for biogenerics. "In 1984, brand companies said that generics would stifle innovation. It didn't happen. They said public health would be jeopardized. It didn't happen. They said the elderly and poor would be harmed. It didn't happen. In fact, more than half of Americans are now filling their prescriptions with safe, effective and affordable generics. Playing the scare card didn't work in 1984 and it won't work in 2007. Brand companies simply want to protect their monopolies. We need competition in the marketplace to increase consumer access and foster incentives for innovation."