High-Cost Generic Drugs—Implications for Patients and Policymakers

The authors document dramatic price increases for off-patent drugs with limited competition driven by manufacturer consolidation, supply disruptions, and the discontinuation of therapeutic alternatives. To mitigate these price spikes, they propose various policy solutions, including FDA-triggered public solicitations for new generic manufacturers when substantial price increases occur, expedited reviews and user fee waivers for companies entering these markets, and temporary importation.