Growing Complex Generic Application Load May Force US FDA Staffing Changes

By Derrick Gingery

Complex products are slowly gaining an increasing share of generic drug applications, but the FDA still feels there is time to plan for staffing and other potential changes that may be needed.

Complex generics eclipsed 13% of all ANDA approvals in fiscal year 2021. The upcoming generic drug user fee program reauthorization includes funding to hire 128 additional full-time staff for the program, likely including some that will handle complex generics. All of the new hires are expected to be made in fiscal year 2023.

Staffing plans for complex generics and other FDA priorities may be complicated by the continual burden of the coronavirus pandemic. Learn what forced the agency to lower hiring and retention expectations earlier this year.