Allan Begosh John Goldsmith Ed Hass Randall W. Lutter Clark Nardinelli John A. Vernon
Abstract
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 2006, and subsequently approved and marketed, we analyze the timing and incidence of BBWs. Our analyses also use data on several drug characteristics likely to affect the probability a new drug will receive a BBW. We draw several conclusions from our analyses. For example, drugs receiving priority FDA review are more likely to have BBWs at the time of approval than NMEs receiving standard review. We also find that early prescription volume and orphan drug status are associated with an increased likelihood of receiving a BBW. We do not, however, find a significant difference in the rate of BBWs across time cohorts. A comparison of NMEs approved before and after the 1992 Prescription Drug User Fee Act (PDUFA), which authorized the payment of user fees from drug manufacturers to the FDA in an effort to expedite new drug application (NDAs) review times, did not reveal a statistically significant difference in the rate of BBWs. Critics of PDUFA maintain that reduced FDA-approval times under PDUFA have compromised drug safety. We do not find empirical support for this contention.
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Paper provided by National Bureau of Economic Research, Inc in its series NBER Working Papers with number
12803.
Length: Date of creation: Dec 2006 Date of revision: Handle: RePEc:nbr:nberwo:12803
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Find related papers by JEL classification: I1 - Health, Education, and Welfare - - Health I11 - Health, Education, and Welfare - - Health - - - Analysis of Health Care Markets I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health I28 - Health, Education, and Welfare - - Education - - - Government Policy K2 - Law and Economics - - Regulation and Business Law K23 - Law and Economics - - Regulation and Business Law - - - Regulated Industries and Administrative Law K32 - Law and Economics - - Other Substantive Areas of Law - - - Environmental, Health, and Safety Law
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