FDA approves fewer generics in FY2020, ending record streak

After 4 consecutive years of posting record numbers of abbreviated new drug application (ANDA) approvals, FDA approved 22% fewer generic drugs in the 2020 fiscal year (FY2020) than it did in the previous fiscal year. In FY2020, FDA approved 909 ANDAs–737 full approvals and 172 tentative approvals–compared with a record 1,171 ANDAs in FY2019. Complete responses came in at 2,010, down from 2,310 in FY2019. The decline comes after FDA increased its focus on generic drug approvals as part of the drug competition action plan championed by former FDA Commissioner Scott Gottlieb. 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. FDA 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. The number of ANDA approvals remains higher than in FY2016 and is just below the numbers achieved in FY2017 and FY2018. The drop in generic approvals also follows several years of fewer ANDAs being submitted to the agency.