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GPhA White Paper on End-point Authentication

WASHINGTON, D.C. (SEPT. 14, 2011) – The Generic Pharmaceutical Association (GPhA) today reaffirmed its commitment to ensuring the safety of the U.S. drug supply chain in testimony before the U.S. Senate Committee on Health, Education, Labor, and Pensions.

“Given that the vast majority of all prescription drugs dispensed in this country are generic drugs, we have a keen interest in making sure the supply chain is safe for American consumers who rely on our medicines,” Gordon Johnston, GPhA Senior Advisor for Regulatory Sciences, said. “We also have a keen interest in a level, competitive and accountable playing field among all participants in the U.S. pharmaceutical supply chain. GPhA is committed to doing everything possible to work with Congress and the FDA to ensure adequate oversight of the nation’s drug supply.”

GPhA has long maintained that the Food and Drug Administration (FDA) needs additional resources to increase the agency’s global reach — including strengthening the foreign drug inspection system and increasing funding for the Office of Generic Drugs.

“Without modernization of the law governing the U.S. drug supply and increased authority and resources to carry out FDA’s oversight of today’s complex and global drug supply, the significant challenges facing the U.S. pharmaceutical marketplace will continue and likely compound,” Johnston said.

The generic drug industry has been a consistent leader in this area, Johnson added. Implementing supply-chain security measures and working with the FDA to help provide the necessary oversight to maintain the nation’s drug supply has been and remains a priority for our member companies, he said.

Additionally, the landmark generic drug user fee program now being finalized with FDA will provide the agency with unprecedented support to achieve this goal. The program “recognizes that while providing earlier access to effective medicines is critical, an equally important pillar of FDA’s mission is ensuring drug safety,” Johnston said.

The Generic Pharmaceutical Association stands ready to support Congress and the FDA in strengthening its oversight, updating the law and investing more resources to ensure the U.S. continues to lead the world in safety while maintaining industry’s competitiveness.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 78 percent of the prescriptions dispensed in the U.S. but consume just 25 percent of the total drug spending. Additional information is available at gphaonline.org.