Do faster food and drug administration drug reviews adversely affect patient safety? An analysis of the 1992 prescription drug user fee act
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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.
Published Version (Please cite this version)10.1086/589934
Publication InfoGrabowski, 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.
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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 been publishing research papers for over four decades, from his earlier work, “The Effects of Regulatory Policy on the Incentives