FDA sets record for generic drug approvals


WASHINGTON — 2016 was a record-setting year for the U.S. Food and Drug Administration’s generic drug program, with its Center for Drug Evaluation and Research generating the highest number of approvals in its history — more than 800 generic drug approvals, including both full approvals and tentative approvals. 

Last year’s performance surpassed 2015’s previous record of 726. Many of these approvals were for “first-time generic drugs,” meaning the introduction of a generic counterpart for a brand-name product for which there was previously no generic. That’s typically the first step towards lower drug prices because multiple generic versions of brand-name drugs drive price competition, leading to more affordable drugs.

“We also are making a significant effort to spur generic drug development,” according to an FDA report written by Kathleen “Cook” Uhl, M.D. “For example GDUFA Regulatory Science priorities contribute valuable research to generic drug development. Our efforts are geared to helping the generic drug industry develop validated scientific methods for demonstrating bioequivalence and assuring therapeutic equivalence to the brand-name counterpart.”

The FDA did acknowledge much needs to be done regarding generic drugs, however. “Despite these developments in 2016, a lot remains to be done as we approach the end of our first-ever five-year GDUFA program. We look forward to working with industry, the research community, physicians, lawmakers, and other stakeholders to help American consumers and advance use of generic drugs in our nation’s health care system.”

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