Firm Characteristics and the Speed of FDA Approval

This paper empirically examines the effect of firm-specific characteristics on the length of time required by the Food and Drug Administration (FDA) to review and approve new-drug applications between 1990 and 1992. The approach treats regulatory decisions as endogenous and explains the variation in regulatory behavior as a function of differences that exist between firms and drugs. Results show that, controlling for drug-specific characteristics, regulators respond to firm-specific characteristics when evaluating new drug applications. For instance, firms that are less diversified and more R&D-inten-sive receive shorter review times for their new-drug applications than more diversified and less R&D-intensive firms. The reason is that most firm characteristics signal information to reviewers about either firm reputation or application quality. This information reduces reviewers’ uncertainty about approving a dangerous or ineffective drug and leads to faster review times. The results suggest that regulators respond to the heterogeneities among firms in the pharmaceutical market in systematic ways.