Black Box Warnings and Drug Safety: Examining the Determinants and Timing of FDA Warning Labels
AbstractComparing 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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Date of creation: Dec 2006
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- I1 - Health, Education, and Welfare - - Health
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- 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
This paper has been announced in the following NEP Reports:
- NEP-ALL-2007-01-13 (All new papers)
- NEP-HEA-2007-01-13 (Health Economics)
- NEP-LAW-2007-01-13 (Law & Economics)
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Forum for Health Economics & Policy,
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- Ernst R. Berndt & Adrian H. B. Gottschalk & Tomas Philipson & Matthew W. Strobeck, 2004. "Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process," NBER Working Papers 10822, National Bureau of Economic Research, Inc.
- Tomas J. Philipson & Ernst R. Berndt & Adrian H. B. Gottschalk & Matthew W. Strobeck, 2005. "Assessing the Safety and Efficacy of the FDA: The Case of the Prescription Drug User Fee Acts," NBER Working Papers 11724, National Bureau of Economic Research, Inc.
- Berndt, Ernst R. & Gottschalk, Adrian H. B. & Philipson, Tomas J. & Strobeck, Matthew W., 2004. "Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process," Working paper 220, Regulation2point0.
- Golec, Joseph H. & Lutter, Randall & Nardinelli, Clark & Vernon, John, 2006. "FDA New Drug Approval Times, Prescription Drug User Fees, and R & D Spending," Working paper 212, Regulation2point0.
- Olson, Mary K., 2008. "The risk we bear: The effects of review speed and industry user fees on new drug safety," Journal of Health Economics, Elsevier, vol. 27(2), pages 175-200, March.
- Philipson, Tomas & Berndt, Ernst R. & Gottschalk, Adrian H.B. & Sun, Eric, 2008. "Cost-benefit analysis of the FDA: The case of the prescription drug user fee acts," Journal of Public Economics, Elsevier, vol. 92(5-6), pages 1306-1325, June.
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