House Bill Would Allow FDA To Waive, Reduce Generic Drug User Fees

Two House Republicans want FDA to waive or reduce generic drug user fees for some manufacturers that could be blocked from the market because of fee requirements, according to a bill introduced Monday (Dec. 2). The Small Manufacturer Protection Act would direct FDA to consider “circumstances and assets” when determining whether to waive or reduce fees, although the agency has countered the need for reduced fees. Republican Reps. Robert Hurt (VA) and Phil Roe (TN) spearheaded the effort, which follows...