Regulatory Review Time and Pharmaceutical R&D

Abstract

In the United States, all newly developed drugs undergo a lengthy review process conducted by the Federal Food and Drug Administration (FDA). These regulatory delays are costly for drug manufacturers and patients. We collected data on review times of drugs approved between 1999 and 2005 and found that, in medical indication categories where it takes the FDA longer to approve drugs, fewer drugs are developed. On average, three additional months of the review process result in one fewer drug in development in that drug category, suggesting that the length of the regulatory delay matters for pharmaceutical firms’ research and development decisions.

Keywords: regulation, pharmaceutical R&D, Federal Food and Drug Administration, drug development

JEL Classification: I18, O38