Format

Send to

Choose Destination
See comment in PubMed Commons below
J Health Econ. 2008 Mar;27(2):175-200. doi: 10.1016/j.jhealeco.2007.10.007. Epub 2007 Nov 29.

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

Author information

  • 1Department of Economics, Tulane University, 6823 St. Charles Avenue, New Orleans, LA 70118-5698, USA. molson@tulane.edu

Abstract

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.

[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk