Biopharma Business

FDA’s Office of Generic Drugs (OGD) released their 2016 Annual Report on Feb. 24, 2017. The report details the office’s accomplishments for the year, including the most-ever approved (630) or tentatively approved (183) abbreviated new drug applications (ANDAs) in the history of the generic drug program.

The report highlights some of the office’s top achievements in 2016, including meeting Generic Drug User Fee Act (GDUFA) performance goals, which were established by he Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). These goals included the agency taking a first action on 90% of the 2866 ANDAs and 1873 post-approval studies (PASs) in process with FDA or industry prior to GDUFA enactment on October 1, 2012. In Spring 2016, the agency met this commitment more than a year ahead of schedule. As of December 31, 2016, FDA had completed first actions on 95% of ANDAs and 93% of PASs.

Additional highlights of the report include the following:

• More than 200 product-specific guidance documents related to the development of generic drugs were published.
• First approvals were granted for generic versions of commonly used drugs including Benicar, Viagra, Crestor, and Tamiflu.
• Funding to 16 new external researchers to conduct regulatory science activities was awarded, and 87 ongoing external research collaborations were supported by the agency in 2016.
• Verified validity of FDA’s bioequivalence standards for certain drugs through scientific studies, demonstrating the proven efficacy and safety of generic drugs.

“It is exciting to see the number of approvals and tentative approvals continuing to rise, but our main focus is always to ensure the safety, effectiveness, and quality of FDA-approved drugs,” OGD’s director, Kathleen Uhl, MD, stated in the report. “We have also begun leveraging international generic drug activities to better understand drivers of the global drug market, which is critical to ensuring consistent quality in generic drugs sold in the United States.”