Important New FDA Action to Support Generic Drug Development and Access

On November 9, 2017, the FDA took another important step to encourage generic drug development and increase generic drug access, a revision to the Center for Drug Evaluation and Research’s Manual of Policies and Procedures 5240.3 (“Prioritization of the Review of Original ANDAs, Amendments, and Supplements”).

This MAPP revision includes the following updates:

• A new prioritization factor for ANDA submissions likely to be ready for approval upon or shortly after expiration of 180-day exclusivity.
• Edits to reduce confusion and clarify the differences between shorter goal dates and expedited reviews.
• Changes to reflect the passage of FDASIA and FDARA, current practices, current agency organizational alignment, and modern terminology.

These actions are part of Commissioner Gottlieb’s recently announced Drug Competition Action Plan, and follow the July 2017 public meeting on administering the Hatch-Waxman Amendments. As the FDA considers comments received both at the meeting and through the public docket, the agency will take additional, related actions in the near future, and will continue to communicate with stakeholders as these new elements are implemented.