FDA Critical Path Initiative: A Generic Industry Perspective

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FDA Critical Path InitiativeA Generic Industry
Perspective

• Shahid Ahmed
• American Pharmaceutical Partners on Behalf of the
  Generic Pharmaceutical Association

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Outline

• Overview of Generic Industry
• Critical Path Initiative Concepts
• Relevance to the Generic Industry
• Benefits of a Critical Path Initiative for the
  Generic Industry

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Overview of Generic Industry

• Important component of the U.S. healthcare system
• Generic drugs comprise 51 of the prescriptions
  dispensed in the US
• Generic Drugs 8 of overall cost of
  prescription drugs
• Several off-patent Innovator products have no
  generic competition due to lack of guidance on
  requirements/or delays in such guidance, for
  example, steroid based Inhalers

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Critical Path Initiative Concepts

• Improved tools for evaluating
• Safety
• Medical utility/efficacy
• Characterization and manufacturing
• FDA expressed innovative thinking
• Provides opportunity to accelerate ground
  breaking research and development

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Critical Path Initiative Concepts

• Promotes enhanced collaboration among FDA,
  industry, academics, patient groups, etc.
• Desired outcome Opportunity for faster, more
  predictable and less costly pathway for drug
  development.

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Relevance to the Pharmacutical Industry

• Primary emphasis on streamlining of drug
  discovery process
• Improve evaluation methods for safety and
  efficacy outcomes
• Increased utilization of FDA expertise and best
  practices experience
• Enhanced communication between FDA and industry

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Benefits of a Critical Path Initiative for the
Generic Industry

• Encourage FDA to continue its innovative outlook
  and develop a Critical Path Initiative focused on
  key problems related to generic drug development

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Benefits of a Critical Path Initiative for the
Generic Industry

• Consider early development of pathways for
  complex products to assist OGD and industry
• MDIs
• Complex drug products
• Protein products
• Other
• GPhA looks forward to collaboration on a Critical
  Path Initiative focused on unique challenges of
  the generic industry

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Benefits of a Critical Path Initiative for the
Generic Industry

• Collaboration with FDA and the Advisory Committee
  for Pharmaceutical Science can be a key component
  in addressing these challenges