Do Faster FDA Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

Posted: 17 Jun 2007

See all articles by Henry G. Grabowski

Henry G. Grabowski

Duke University - Department of Economics

Richard Wang

Temple University

Abstract

FDA review times have significantly declined since the passage of PDUFA in 1992, while agency resources have expanded through user fees. After the recent withdrawal of Vioxx and other high-profile products, there have been increasing concerns that PDUFA has adversely affected drug safety. Combining several comprehensive databases, we analyze how FDA review time, drug novelty, and U.S. launch lag affect the occurrence of serious adverse events 1992-2002 U.S. new drug introductions. We find that more novel drugs and those with shorter U.S. launch lags have a larger number of serious events. After controlling for these and other factors, there is no association between FDA review time and adverse events. Many novel products, with significant anticipated benefits and risks, have black box warnings at the time of product launch. We find that black box warnings (except for pregnancy ones) are associated with more serious events. Notably, many serious adverse events involve rare occurrences that are not observable in pre-market clinical trials. Policymakers should consider our findings in future PDUFA changes, including dedicating a portion of user fees to post-marketing surveillance.

Suggested Citation

Grabowski, Henry G. and Wang, Y. Richard, Do Faster FDA Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act. Journal of Law and Economics, Forthcoming; iHEA 2007 6th World Congress: Explorations in Health Economics Paper. Available at SSRN: https://ssrn.com/abstract=994319

Henry G. Grabowski (Contact Author)

Duke University - Department of Economics ( email )

213 Social Sciences Building
Box 90097
Durham, NC 27708-0204
United States
919-660-1839 (Phone)

Y. Richard Wang

Temple University ( email )

Philadelphia, PA 19122
United States

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