Do faster food and drug administration drug reviews adversely affect patient safety? An analysis of the 1992 prescription drug user fee act
Abstract
Food and Drug Administration (FDA) review times have significantly declined under
the user-fee regime. This situation has provoked concerns that drug safety has been
adversely affected. Combining information from several comprehensive databases, we
analyze how the FDA's review time, a drug's novelty, and a lag between the foreign
and U.S. launches of a drug affect the number of serious adverse events associated
with new-drug introductions in the United States in 1992-2002. We find that more novel
drugs, those with shorter U.S. launch lags, and those with black-box warnings have
a larger number of serious adverse events. After controlling for these and other factors,
we find no association between the FDA's review time and adverse events. Because many
serious adverse events involve rare occurrences that are not observable in premarket
clinical trials, policy makers should direct increased agency attention and resources
to postmarketing surveillance. © 2008 by The University of Chicago. All rights reserved.
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https://hdl.handle.net/10161/6713Published Version (Please cite this version)
10.1086/589934Publication Info
Grabowski, H; & Wang, YR (2008). Do faster food and drug administration drug reviews adversely affect patient safety?
An analysis of the 1992 prescription drug user fee act. Journal of Law and Economics, 51(2). pp. 377-406. 10.1086/589934. Retrieved from https://hdl.handle.net/10161/6713.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
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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