Restrictive FDA Requirements and the Development of Generic Topical Medications

To the Editor In a recent issue of JAMA Dermatology, Li et al reported on the inverse association between change in drug price and the median number of manufacturers of generic topical dermatologic drugs. The authors discuss the importance of policy changes aimed at destabilizing existing drug monopolies and duopolies. While the authors discuss some of the barriers of entry faced by manufacturers, they fail to discuss the impact of US Food and Drug Administration (FDA) policies surrounding generic topical medications.

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