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GPhA Statement in Response to the Federal Trade Commission Interim Report on Authorized Generic Drugs

Arlington, VA, June 24, 2009 – The Generic Pharmaceutical Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger in response to the release of the FTC Interim Report on Authorized Generic Drugs.

“While we have not had an opportunity to read the entire FTC report, the fact is that authorized generics harm, not help consumers. Authorized generics are yet another tactic that brand pharmaceutical companies have in their arsenal to keep affordable generic medicines from consumers.

“Authorized generics undermine Congressional intent by undercutting the 180-day exclusivity period for generic manufacturers. Congress provided the 180-day incentive as a means to foster investment by generic companies to challenge questionable and weak brand patents with the ultimate goal of providing more timely access to and greater choices of affordable medicines. Simply put, but for the generic challenger, there would be no price competition. Permitting brand companies to undercut the incentive is just not sound public policy.

“Undercutting the 180-day exclusivity period is a bad move for consumers. The generic industry experience has shown that this incentive has resulted in numerous patent challenges, yielding greater competition. And when patent settlements occur, they save consumers tens of billions of dollars.

“There is a reason why generic medicines have resulted in an astounding $734 billion in savings to the health care system in the last decade and that’s because generics bring competition into the system allowing consumers to access the same medicines as brands, but at lower costs. That’s why GPhA supports bipartisan legislation which would prohibit the marketing of an authorized generic during the 180-day generic exclusivity period following a patent challenge.”

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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