USFDA aims to foster generic drugs

A recent email announcement by USFDA lists the details

Today the FDA took two important new steps to encourage generic drug development and increase generic drug access:

  • A revision to “Prioritization of Review of Original ANDAs, Amendments, and Supplements” (MAPP 5240.3), which now allows for the prioritized review of generic drug applications until there are three approved generics for a given drug product. The agency revised this policy based on data that indicates consumers see significant price reduction when there are at least three FDA-approved generics available.
  • Publication of the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” which the agency will continue to refine and periodically update to ensure continued transparency regarding opportunities for competition.

These actions are part of Commissioner Gottlieb’s recently announced Drug Competition Action Plan, and follow the announcement of next month’s public meeting on administering the Hatch-Waxman Amendments. The agency plans to take additional, related actions in the near future, and will continue to communicate with stakeholders as these new elements are implemented.

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