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GPhA Statement on White House Letter Rejecting 12 to 14 Year Exclusivity Period for Biogenerics

Arlington, VA, June 25, 2009 – The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger on the Obama Administration’s letter to Chairman Henry Waxman on biogenerics.

“As Congress debates health care reform, the White House has sent a strong signal to members that it is critical to ensure that affordable lifesaving biogeneric medicines get to patients in need sooner rather than later. In citing the recent FTC report on biogenerics, the President rejects attempts by the pharmaceutical and biotech industries to needlessly extend market exclusivity provisions to an unprecedented period of 12 to 14 years simply to maintain their monopolies on biopharmaceutical products. The White House and Office of Management and Budget (OMB) correctly recognize that this exclusivity model will not achieve what should be our shared goal of balancing pharmaceutical innovation and much needed consumer access.

“While the generic industry still supports the proven successful Hatch-Waxman model as contained in the bipartisan ‘Promoting Innovation and Access to Lifesaving Medicines Act,’ we commend the President for working to move this issue forward by recommending a seven-year exclusivity compromise. Countless Americans are waiting for more affordable biogenerics to treat their serious medical conditions and it is clear that 12 to 14 years of exclusivity will do nothing to get them the help they desperately need.

“We also applaud the Obama Administration for working with the FDA to ensure that it is able to put an abbreviated approval pathway in place as quickly as possible. It is evident that this President knows that increasing access to affordable biogeneric medicines is not only the right solution for better health, it’s also the right prescription for reducing skyrocketing health care 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 about the industry, visit www.gphaonline.org.
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