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MOSL: HEALTHCARE-US FDA introduces policy to expedite approval process-Empirical evidence analysis

​Healthcare: US FDA introduces policy to expedite approval process; Empirical evidence analysis

• The US FDA has announced two measures with an aim to promote competition and expedite the approval process.
  
• US FDA publishes a list of off-patent, off-exclusivity branded drugs without approved generics (Link to the list): Part 1 of the list includes 194 drugs, where the FDA could immediately accept an ANDA without prior discussion. Part 2 of the list includes 128 drugs that involve potential legal, regulatory or scientific issues, which should be addressed with the agency prior to submission of an ANDA.
  
• US FDA formulates a new policy to expedite the review of generic drug applications where competition is limited (Link to the detailed policy). The FDA will expedite the review of generic drug applications until there are three approved generics for a given drug product. There are several other criteria as well in which a firm can apply for expedited review of its ANDA application (e.g. when there are drug shortages).
  
• FDA guidelines to facilitate more generic competition: The US FDA has outlined eight cases in which it will prioritize the ANDA review process. This initiative is in line with the US FDA commissioner and the government’s strategy to promote competition. Channel consolidation, along with more competitors in the market, will lead to price erosion in the base business beyond FY18 as well.