March 2004

Innovation or Stagnation: Challenge and Opportunity on the Path to New Medical Products

This report provides the Food and Drug Administration's (FDAs) analysis of the pipeline problem the recent slowdown, instead of the expected acceleration, in innovative medical therapies reaching patients. Today's revolution in biomedical science has raised new hope for the prevention, treatment, and cure of serious illnesses. However, there is growing concern that many of the new basic science discoveries made in recent years may not quickly yield more effective, more affordable, and safe medical products for patients. This is because the current medical product1 development path is becoming increasingly challenging, inefficient, and costly. During the last several years, the number of new drug and biologic applications submitted to FDA has declined significantly; the number of innovative medical device applications has also decreased. In contrast, the costs of product development have soared over the last decade.