House Committee Quizzes FDA on Complex Generic Drugs

A bipartisan group of House Energy & Commerce Committee leaders last Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Stephen Hahn seeking information on the agency’s efforts to approve complex generic drugs more quickly.

The congressmen said they are trying to understand if FDA needs additional authority to improve the approval process for complex generic drugs, which can be more difficult to formulate or manufacture than other generic drugs.