The United States Food and Drug Administration (FDA) set a new record for generic drug approvals in October 2018, RAPS reports. The new number to beat is 128. The 128-total comprised of 110 approvals and 18 tentative approvals, and also included 23 first generic drug approvals and 17 complex generics.¹ FDA has been on a record-setting approval pace as of late, completing 971 total approvals in FY 2018 (a new record), eclipsing previous record of 937 total approvals in FY 2017.
Speaking about the consumer impact of the Agency’s accelerating approval times of generic drugs, FDA Commissioner Scott Gottlieb stated that “Through our efforts, generic drugs entering the market from January 2017 through July 2018 saved consumers $26 billion through the lower prices they enabled. And perhaps more importantly, our efforts are having a real impact on reducing the number of review cycles of generic drug applications, making the process more efficient overall so that we can dedicate our resources to getting quality generic medicines to Americans sooner.”¹ Gottlieb’s comments reflect the Agency’s efforts to indirectly impact the cost of medicines² and the scrutiny which the pharmaceutical industry has recently faced regarding the cost of prescription drugs.
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¹https://www.raps.org/news-and-articles/news-articles/2018/11/fda-hits-monthly-generic-drug-approval-record-in-o
²https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm