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GPhA and FDA Share Goal of Maintaining the World’s Most Stringent Generic Pharmaceutical Approval Process

BETHESDA, MD., OCTOBER 21, 2010 – The following statement was issued today by the Generic Pharmaceutical Association (GPhA) following comments made at the GPhA/FDA Fall Technical Conference related to the therapeutic equivalence of generic drugs.

“The FDA’s demanding generic review and approval procedures for generic drug applications are the gold standard for regulatory agencies around the world. Consumer confidence in this rigorous process is abundantly clear given that approximately 76% of all prescriptions dispensed in the U.S. are filled with safe, effective and affordable generic drugs (source: IMS Health, 2010).

"As the FDA has repeatedly stated about therapeutic equivalence, ‘A generic drug must be shown to be bioequivalent to the reference [brand] drug. Through review of bioequivalence data, FDA assures that the generic product will perform the same as its respective brand name (or reference) product’ (www.fda.gov).

“As evident from the GPhA/FDA Fall Technical Conference this week, generic industry companies and the FDA share a unique partnership and commitment to assuring consumers and patients that all drugs – brand and generic – are safe and effective. In fact, forums such as this conference provide opportunities for all constituents in our industry to seek ways to partner with FDA to ensure the generic drug approval process is the most stringent in the world. FDA has the ultimate authority to ensure the safety of the pharmaceuticals in America’s medicine cabinets and to preserve the confidence that consumers place in our products. We are committed to working with FDA to maintain that trust. To do anything less would not only be contrary to the interest of the patients our industry proudly serves, it would be contrary to the mission of the FDA.”

“Three billion of the four billion prescriptions dispensed in the U.S. this year will be filled with FDA-approved generic drugs. Generics enable consumers to meet their medicine needs at a cost of up to 80% less than what they would have to pay if generics were not available. Generics enable millions of Americans to afford the medicines they need to live healthier and more productive lives, while at the same time saving the U.S. healthcare system one billion dollars every three days.”

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 75 percent of the prescriptions dispensed in the U.S. but consume just 22 percent of the total drug spending. Additional information is available at gphaonline.org.

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