An increase in new drugs first launched in the U.S. and shorter lags between first global drug launch and U.S. approval indicate that the U.S. drug lag has declined. This paper examines the impact of these changes on drug safety using adverse drug reaction data for FDA-approved drugs in 1990 to...

This article develops a framework to understand the factors to which regulatory agencies respond and examines how these factors may influence agency decision-making. The model shows how either changing feedback from constituents or changing regulatory costs can alter the trade-offs facing the...

This paper develops a theoretical framework to analyze the variability in Food and Drug Administration (FDA) approval decisions among competing industries including those that produce new brand-name drugs, generic drugs, and medical devices. The theory provides a framework to empirically test...

Drug review speed has increased substantially in the 1990s, largely due to industry-funded user fees. Following several drug withdrawals, however, new questions have emerged about the effects of this change on drug safety. This article examines the impact of review speed and user fees on counts...

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...

This paper investigates the impact of UK pharmaceutical policy on the level of NHS pharmaceutical expenditure. UK pharmaceutical policy is one which has managed to control costs, but at the same time, has not sacrificed the rewards for conducting long-term R&D in the UK. The analysis provides...