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GPhA Statement on the Introduction of the Bipartisan Senate Biogenerics Consensus Bill

GPhA Statement on the Introduction of the Bipartisan Senate Biogenerics Consensus Bill:
“Promoting Innovation and Access to Life-Saving Medicine Act”
Companion Senate Bill Puts Patient Health and Safety and Pharmaceutical Innovation First

Arlington, VA, March 26, 2009 – The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding the bipartisan Senate introduction of the “Promoting Innovation and Access to Life-Saving Medicine Act.”

“Momentum is skyrocketing for biogenerics legislation that puts patients and pharmaceutical innovation first. The legislation introduced today in the Senate and last week in the House demonstrates that lifesaving biogenerics can get to patients in need sooner rather than later while also fostering competition to drive pharmaceutical innovation. We applaud Senators Chuck Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), Mel Martinez (R-FL), Jeanne Shaheen (D-NH), Debbie Stabenow (D-MI) and David Vitter (R-LA) for their commitment to increasing access to these life-saving medicines while also ultimately reducing overall health care costs.

“This bipartisan consensus bill holds generic companies to the same quality, safety and science-based standards as brand companies when they make subsequent product changes of their biopharmaceutical medicines. This consensus bill also provides FDA with the same scientific discretion regarding approval criteria for biogenerics and biosimilars as they have for biopharmaceuticals. There should be one gold standard for science, quality and safety and this legislation provides that standard while also creating a system of market exclusivity that has allowed both the brand and generic industries to flourish together for 25 years to the benefit of consumers.

“Reducing overall health care costs while increasing access to quality care is essential to achieving real health care reform. With studies showing that biogenerics legislation will produce significant savings, it is critical that Congress act to ensure these affordable life-saving medicines get to patients in a timely manner.

“Momentum is not only growing in Congress, but across the country, with millions of Americans represented by leading consumer, business and labor organizations and AARP supporting this legislation that puts equality into the system and needed medicines into the hands of consumers.

“It’s time to enact legislation that gives FDA the authority and flexibility to create a workable biogenerics approval pathway that upholds their gold standard of ensuring safety and quality. We don’t need a pathway that’s so filled with roadblocks that it is merely an empty promise for patients. Let’s fulfill our promise to patients and to strengthening our health care system by passing the ‘Promoting Innovation and Access to Life-Saving Medicine Act’.”

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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