John Goldsmith
Suite 15-36
Office of the Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
E-Mail: 
NBER Working Papers and Publications
| December 2006 | Black Box Warnings and Drug Safety: Examining the Determinants and Timing of FDA Warning Labels
with Allan Begosh, Ed Hass, Randall W. Lutter, Clark Nardinelli, John A. Vernon: w12803
Comparing the safety of prescription drugs over time is difficult due to the paucity of reliable quantitative measures of drug safety. Both the academic literature and popular press have focused on drug withdrawals as a proxy for breakdowns in the drug safety system. This metric, however, is problematic because withdrawals are rare events, and they may be influenced by factors beyond a drug's safety profile. In the current paper, we propose a new measure: the incidence and timing of Black Box Warnings (BBWs). BBWs are warnings placed on prescription drug labels when a drug is determined to carry a significant risk of a serious or life-threatening adverse event. Using a unique data set, one that includes all new molecular entities (NMEs) submitted to the FDA between May 1981 and February 20... |
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