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Accounting for “Lost Pleasure” in a Cost–Benefit Analysis of Government Regulation: The Case of the Food and Drug Administration's Proposed Cigarette Labeling RegulationFDA's Proposed Cigarette Labeling Regulation

Frank J. Chaloupka, PhD; Jonathan Gruber, PhD; and Kenneth E. Warner, PhD
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 14 October 2014.

From University of Illinois at Chicago, Chicago, Illinois; Massachusetts Institute of Technology, Cambridge, Massachusetts; and University of Michigan, Ann Arbor, Michigan.

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1910.

Requests for Single Reprints: Jonathan Gruber, PhD, Department of Economics, Massachusetts Institute of Technology, 40 Ames Street, E17-220, Cambridge, MA 02139; e-mail, gruberj@mit.edu.

Current Author Addresses: Dr. Chaloupka: Institute for Health Research and Policy, University of Illinois at Chicago (MC 275), 444 Westside Research Office Building, 1747 West Roosevelt Road, Chicago, IL 60608.

Dr. Gruber: Department of Economics, Massachusetts Institute of Technology, 40 Ames Street, E17-220, Cambridge, MA 02139.

Dr. Warner: University of Michigan School of Public Health, M3174, SPH II, 1420 Washington Heights, Ann Arbor, MI 48109-2029.

Author Contributions:Conception and design: F.J. Chaloupka, J. Gruber, K.E. Warner.

Analysis and interpretation of the data: F.J. Chaloupka, J. Gruber.

Drafting of the article: F.J. Chaloupka, J. Gruber.

Critical revision of the article for important intellectual content: F.J. Chaloupka, J. Gruber, K.E. Warner.

Final approval of the article: F.J. Chaloupka, J. Gruber, K.E. Warner.

Provision of study materials or patients: J. Gruber.

Statistical expertise: J. Gruber.

Obtaining of funding: F.J. Chaloupka, K.E. Warner.

Administrative, technical, or logistic support: J. Gruber.

Collection and assembly of data: J. Gruber.

Ann Intern Med. 2015;162(1):64-65. doi:10.7326/M14-1910
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The U.S. Food and Drug Administration (FDA) prepared an economic impact analysis of a proposed rule for graphic warning labels on tobacco products. This commentary discusses the analysis and finds fault with the FDA's decision to include the “lost pleasure” from tobacco use as a cost in economic impact analyses of regulations.

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Posted on November 4, 2014
Alain Braillon MD, PhD
Public Health. Northern Hospital, France
Conflict of Interest: None Declared
Chaloupka and colleagues wisely challenged the U.S. Food and Drug Administration (FDA) decision to prepare an economic impact analysis of tobacco regulations. How FDA can be concerned by the “lost pleasure” from tobacco use due to warning labels? (1) Chaloupka and colleagues’ point is well evidenced based and goes beyond simple common sense. However, they should have analyzed this decision in the context of other recent decisions.
First, the 2009 Tobacco Control Act has given FDA the authority to regulate tobacco, but FDA’s Advisory Committee choose not to recommend a ban on menthol cigarettes despite all the evidence of its devastating effects. This is a major setback for public health.(3) Brazil has banned menthol and it is on the agenda in Europe.
Second, FDA’s Center for Tobacco Products recently announced a new goal: analyzing cigarette constituents more accurately to help fill current gaps regarding the chemical and physical properties of tobacco products, and more generally, improve information regarding the harms associated with tobacco use. “Quality control and sample testing parameters … will be conducted … to allow for certification of product physical parameters and constituent levels ...” (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/ucm391336.htm)” Cigarettes kill more 470,000 US people annually, one out of two smokers. Can quality control replace tobacco control?
Third, on other issues FDA must be question too. Wolfe rightly stressed that the draft guidance from for industry on distributing medical publications about the risks of prescription drugs is a misguided approach which undermines its public health mission for drug safety policy.(3) This guidance is even more challenging as the frequency of safety problems and drug withdrawals, have increased since 1992, when the Prescription Drug User Fee Act, a legislation designed to accelerate the FDA drug approval process, was passed.(4)
Last, in May 2013 FDA banned Mimolette, a French cheese. Some said it could be more a retaliation to prevent the Europe from banning US GMO food exports than a public health concern.
FDA seems more and more prone to protect vested industrial interests rather than health of the public. It may be not surprising that 37 percent of Americans believe that FDA is intentionally suppressing natural cures for cancer because of drug company pressure.(5) It is common to disparage adherents of conspiracy theories as a delusional fringe of paranoid cranks. However, failure to question if FDA is on a very slippery slope may be schizophrenia.

1 Chaloupka FJ, Gruber J, Warner KE. Accounting for "Lost Pleasure" in a Cost-Benefit Analysis of Government Regulation: The Case of the FDA's Proposed Cigarette Labeling Regulation. Ann Intern Med 2014. Online Oct 14. doi: 10.7326/M14-1910.
2 Siegel M. A Lost opportunity for public health - The FDA Advisory Committee Report on menthol. N Engl J Med 2011;364:2177-9.
3 Wolfe SM. Proposed US Food and Drug Administration guidance for industry on distributing medical publications about the risks of prescription drugs and biological products. A misguided approach. JAMA Intern Med 2014. Online Aug 15. doi: 10.1001/jamainternmed.2014.4547.
4 Frank C, Himmelstein DU, Woolhandler S et al. Era Of Faster FDA drug approval has also seen increased black-box warnings and market withdrawals. Health Aff 2014;33:81453-1459.
5 Oliver JE, Wood T. Medical conspiracy theories and health behaviors in the United States. JAMA Intern Med 2014;174:817-8.
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