Browsing by Author "Grabowski, H"

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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
    (Journal of Law and Economics, 2008-05-01) Grabowski, H; Wang, YR
    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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    How did the 2003 prescription drug re-importation bill pass the house?
    (Economics and Politics, 2006-03-01) Gokcekus, O; Adams, M; Grabowski, H; Tower, E
    We examine the major interest groups in the debate over allowing the re-importation of prescription drugs by utilizing a logit model and instrumental variables. Consistent with political support approach, the evidence suggests that Representatives are maximizing their electoral prospects: Contributions from pharmaceutical manufacturers shrink the probability of voting for the bill; and Representatives are sensitive to their constituencies - employees of pharmaceutical manufacturing and senior citizens. Representatives' gender and ideology regarding free trade and subsidies are also determining factors. However, the decision was, by and large, a partisan one: Party affiliation was the most important factor in passing the bill. © 2006 The Authors. Journal compilation © 2006 Blackwell Publishing Ltd.