FDA Generic Drug Approvals Down in 2020

October 22, 2020 – Breaking a four-year pattern of approving record numbers of generic drugs, the U.S. FDA issued 909 generic drug approvals in fiscal year (FY) 2020 compared to 1,171 in FY2019. This represents a 22% decrease from FY2019 to FY2020.

The COVID-19 pandemic may have played a role in the lower numbers for FY2020. It has forced the FDA to shift resources to respond to the global health crisis while creating new operational challenges for boththe agency and the pharmaceutical industry. One such challenge is on-site inspections of manufacturing facilities as part of the generic drug approval process.

However, the pandemic may not be solely responsible for the decline in generic drug approvals. The FDA has seen a slow decline in the number of applications received for generic drug approvals since 2017.

Despite the 22% drop, the number of generic drug approvals issued in FY2020 is still high, exceeding the 835 generic drug approvals granted in FY2016, which at that time was a new record.