According to the Regulatory Affairs Professionals Society (RAPS), the U.S. Food and Drug Administration (FDA) has broken its streak by approving 22% fewer generic drugs in the fiscal year 2020 (FY2020) than it did in FY2019.
The FDA approved fewer generic medicines after “four straight years of posting record numbers of abbreviated new drug application (ANDA) approvals.”
“In FY2020, FDA approved a total of 909 ANDAs, 737 full approvals, and 172 tentative approvals, compared to a record 1,171 ANDAs in FY2019,” according to RAPS. “Complete responses also declined to 2,010 compared to 2,310 in FY2019.”
The number of approvals decreased after FDA increased its focus on approving generic drugs as part of the “drug competition action plan” supported by former FDA Commissioner Dr. Scott Gottlieb and “three years into the second Generic Drug User Fee Amendments (GDUFA II) program,” said RAPS.
RAPS wrote on its website, “It is also unclear how big a role the COVID-19 pandemic has played in FDA’s performance in approving generic drugs due to restrictions in conducting facility inspections and shifting resources to respond to the pandemic.”
“The agency has said it is working to meet its user fee commitments, but officials have acknowledged that some goal dates have been missed due to the inability to conduct on-site preapproval inspections,” it added.
However, the number of FDA’s ANDA approvals remains higher in FY2020 than in FY2016. It is just below the numbers achieved in FY2017 and FY2018.
“The drop in generic approvals also follows several years of declining numbers of ANDAs being submitted to the agency from a peak of 1,306 applications received in FY2017 and a slight decline in the number of ANDAs awaiting FDA action since FY2018,” RAPS wrote. “The agency has also observed a steady decrease in the number of applications it has had to issue a refuse to receive (RTR) for since FY2016,” it added.
