Agency works to speed approvals and improve access to generic prescription drugs.

In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott Gottlieb’s Drug Competition Action Plan — to encourage the development of generic prescription drug products with the goal of lowering prescription drug prices. For example, on June 27, 2017, the FDA issued a news release announcing the publication of a list of off-patent, off-exclusivity drugs without approved generics. In the same news release, FDA announced an internal policy revision governing prioritization of Agency review of original abbreviated new drug applications (ANDAs), amendments, and supplements to expedite review of generic drug applications when competition is limited. According to FDA Commissioner Gottlieb, these actions “are the first of a series of steps the [FDA] intends to take to help” patients afford the cost of prescription drugs.