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