000			03972cam a22004457 4500
001			w12803
003			NBER
005			20211020112133.0
006			m o d
007			cr cnu||||||||
008			210910s2006 mau fo 000 0 eng d
100	1		_aBegosh, Allan.
245	1	0	_aBlack Box Warnings and Drug Safety: _bExamining the Determinants and Timing of FDA Warning Labels / _cAllan Begosh, John Goldsmith, Ed Hass, Randall W. Lutter, Clark Nardinelli, John A. Vernon.
260			_aCambridge, Mass. _bNational Bureau of Economic Research _c2006.
300			_a1 online resource: _billustrations (black and white);
490	1		_aNBER working paper series _vno. w12803
500			_aDecember 2006.
520	3		_aComparing 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.
530			_aHardcopy version available to institutional subscribers
538			_aSystem requirements: Adobe [Acrobat] Reader required for PDF files.
538			_aMode of access: World Wide Web.
588	0		_aPrint version record
690		7	_aI1 - Health _2Journal of Economic Literature class.
690		7	_aI11 - Analysis of Health Care Markets _2Journal of Economic Literature class.
690		7	_aI18 - Government Policy • Regulation • Public Health _2Journal of Economic Literature class.
690		7	_aI28 - Government Policy _2Journal of Economic Literature class.
690		7	_aK2 - Regulation and Business Law _2Journal of Economic Literature class.
690		7	_aK23 - Regulated Industries and Administrative Law _2Journal of Economic Literature class.
690		7	_aK32 - Energy, Environmental, Health, and Safety Law _2Journal of Economic Literature class.
700	1		_aGoldsmith, John.
700	1		_aHass, Ed.
700	1		_aLutter, Randall W.
700	1		_aNardinelli, Clark.
700	1		_aVernon, John A. _929896
710	2		_aNational Bureau of Economic Research.
830		0	_aWorking Paper Series (National Bureau of Economic Research) _vno. w12803.
856	4	0	_uhttps://www.nber.org/papers/w12803
856			_yAcceso en línea al DOI _uhttp://dx.doi.org/10.3386/w12803
942			_2ddc _cW-PAPER
999			_c335332 _d293894