FDA approves fewer generics in FY2020, ending record streak

Regulatory NewsRegulatory News | 21 October 2020 |  By 

After four straight years of posting record numbers of abbreviated new drug application (ANDA) approvals, the US Food and Drug Administration (FDA) has broken its streak, approving 22% fewer generic drugs in FY2020 than it did in FY2019.
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. Complete responses also declined to 2,010 compared to 2,310 in FY2019. (RELATED: Another record year for generic drug approvals but questions on competition remain, Regulatory Focus 16 October 2019; FDA sets record for number of generic drug approvals again, Regulatory Focus 11 October 2018).
FDA ANDA Metrics FY2016-FY2020
ANDAs FY2016 FY2017 FY2018 FY2019 FY2020
Approvals 651 763 781 935 737
Tentative approvals 184 174 190 236 172
Total approvals 835 937 971 1,171 909
Complete responses 1,725 1,603 2,648 2,310 2,010
ANDAs received 852 1,306 1,044 909 865
Refuse to receive – originals 246 142 127 52 36*
*does not include data for September 2020
The dip in approvals 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 and three years into the second Generic Drug User Fee Amendments (GDUFA II) program.
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. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings, Regulatory Focus 27 May 2020; Top CDER officials discuss budget priorities, staffing and COVID, Regulatory Focus 16 October 2020).
While down from its FY2019 peak, 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 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. 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.


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