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The risk we bear: The effects of review speed and industry user fees on new drug safety

  • Olson, Mary K.

Drug review speed has increased substantially in the 1990s, largely due to industry-funded user fees. Following several drug withdrawals, however, new questions have emerged about the effects of this change on drug safety. This article examines the impact of review speed and user fees on counts of serious adverse reactions among drugs approved in 1990-2001. The analysis controls for the influence of drug utilization, patient conditions, drug novelty, black box warnings, foreign drug launch, US launch lags, patient age, and gender on drug reactions. Results show that drugs receiving faster reviews are associated with increased counts of serious adverse drug reactions. Other results show that novel drugs, drugs with black box warnings, drugs first launched abroad, and drugs with shorter US launch lags also have increased adverse drug reactions. Although any increase in risks must be weighed against benefits, the results show a trade-off between review speed and drug safety.

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File URL: http://www.sciencedirect.com/science/article/B6V8K-4R7NPWM-G/1/ab53cac6bcf57d8bc427634cfec82d89
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Article provided by Elsevier in its journal Journal of Health Economics.

Volume (Year): 27 (2008)
Issue (Month): 2 (March)
Pages: 175-200

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Handle: RePEc:eee:jhecon:v:27:y:2008:i:2:p:175-200
Contact details of provider: Web page: http://www.elsevier.com/locate/inca/505560

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  1. Olson, Mary K., 2004. "Are novel drugs more risky for patients than less novel drugs?," Journal of Health Economics, Elsevier, vol. 23(6), pages 1135-1158, November.
  2. Frank R. Lichtenberg, 2005. "Pharmaceutical Knowledge-Capital Accumulation and Longevity," NBER Chapters, in: Measuring Capital in the New Economy, pages 237-274 National Bureau of Economic Research, Inc.
  3. Sam Peltzman, 1986. "The Health Effects of Mandatory Prescriptions," University of Chicago - George G. Stigler Center for Study of Economy and State 38, Chicago - Center for Study of Economy and State.
  4. Allan Begosh & John Goldsmith & Ed Hass & Randall W. Lutter & Clark Nardinelli & John A. Vernon, 2006. "Black Box Warnings and Drug Safety: Examining the Determinants and Timing of FDA Warning Labels," NBER Working Papers 12803, National Bureau of Economic Research, Inc.
  5. Mary K. Olson, 2002. "Pharmaceutical Policy Change and the Safety of New Drugs," Journal of Law and Economics, University of Chicago Press, vol. 45(S2), pages 615-642.
  6. Mary K. Olson, 1997. "Firm Characteristics and the Speed of FDA Approval," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 6(1), pages 377-401, 06.
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