Do Faster FDA Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act
Abstract
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.
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https://hdl.handle.net/10161/2075Collections
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Henry G. Grabowski
Professor Emeritus of Economics
Professor Grabowski specializes in the investigation of economics in the pharmaceutical
industry, government regulation of business, and the economics of innovation. His
specific interests within these fields include intellectual property and generic competition
issues, the effects of government policy actions, and the costs and returns to pharmaceutical
R&D. He has over one hundred peer reviewed articles analyzing the economics of pharmaceuticals
and also several books and monograph publica

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