The FDA's generic dilemma

By Dr Nicola Davies

The annual generic drug approvals by the US Food and Drug Administration have been falling since 2020, with 737 generics approved1 in fiscal year 2020 and 6792 in fiscal year 2021 – the latter being the lowest in five years.

The first quarter of FY 2022 saw the approval of only 150 generics,3 indicating the lowest generic approval rate in six years for 2022 if this trend continues. We discuss the reasons behind this downward trend, the implications, and the actions being taken by the FDA to address this situation.