Jan 02, 2016
FDA Critical Path Initiative:A Generic Industry
Perspective
Shahid AhmedAmerican Pharmaceutical Partners on Behalf of the Generic Pharmaceutical
Association
Outline
• Overview of Generic Industry• Critical Path Initiative Concepts• Relevance to the Generic Industry• Benefits of a Critical Path Initiative for the
Generic Industry
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
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
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.
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
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
Benefits of a Critical Path Initiative for the Generic Industry
• Consider early development of pathways for complex products to assist OGD and industry– MDI’s – Complex drug products– Protein products– Other
• GPhA looks forward to collaboration on a Critical Path Initiative focused on unique challenges of the generic industry
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