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Do faster food and drug administration drug reviews adversely affect patient safety? An analysis of the 1992 prescription drug user fee act

Publication ,  Journal Article
Grabowski, H; Wang, YR
Published in: Journal of Law and Economics
May 1, 2008

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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Published In

Journal of Law and Economics

DOI

ISSN

0022-2186

Publication Date

May 1, 2008

Volume

51

Issue

2

Start / End Page

377 / 406

Related Subject Headings

  • Economics
  • 3801 Applied economics
  • 1801 Law
  • 1402 Applied Economics
 

Citation

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Chicago
ICMJE
MLA
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Grabowski, H., & Wang, Y. R. (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), 377–406. https://doi.org/10.1086/589934
Grabowski, H., and Y. R. Wang. “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, no. 2 (May 1, 2008): 377–406. https://doi.org/10.1086/589934.
Grabowski, H., and Y. R. Wang. “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, vol. 51, no. 2, May 2008, pp. 377–406. Scopus, doi:10.1086/589934.
Journal cover image

Published In

Journal of Law and Economics

DOI

ISSN

0022-2186

Publication Date

May 1, 2008

Volume

51

Issue

2

Start / End Page

377 / 406

Related Subject Headings

  • Economics
  • 3801 Applied economics
  • 1801 Law
  • 1402 Applied Economics