Chapter 8.C.1 (6.C.1) Restricting Consumer Choice to Protect Public Health
Notes: The Scope and Constitutionality of Pharmaceutical Regulation
Note 4. Pharmaceutical Choice as a Constitutional Right?
A number of commentators have focused on the concept of rights in pharmaceutical access in the aftermath of the Abigail Alliance litigation discussed in the text. For a sampling of articles see George Annas, Cancer and the Constitution, 357 New Eng. J. Med 4 (2007); Richard Epstein, The Erosion of Individual Autonomy in Medical Decision-making: Of the FDA and IRBs, 96 Geo. L.J. 559 (2008); Elizabeth Weeks Leonard, The Public’s Right to Health: When Patients Rights Threaten the Commons, 86 Wash. U. L. Rev. 1335 (2009).
Note 5. The FDA and Drug Development Efforts.
See also Elizabeth Weeks Leonard, The Public’s Right to Health: When Patient Rights Threaten the Commons, 86 Wash. L. Rev. 1335 (2009), available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1234542## (arguing that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development, depleting the “commons” of biomedical research).
Note 6. Women and Minorities in Drug Research.
See Marya Viorst Gwadz et al, Increasing and Supporting the Participation of Persons of Color Living with HIV/AIDS in AIDS Clinical Trials, 7 Curr HIV/AIDS Rep 194 (2010).
Note 7. Drug Labeling, “Off-Label Use” and the Learned Intermediary.
For more on the regulation of off-label drug use, see Randall S. Stafford, Regulating Off-Label Drug Use – Rethinking the Role of the FDA, 358 New Eng. J. Med. 1427 (2008). See also Muriel R. Gillick, Controlling Off-Label Medication Use, 150 Annals of Int. Med. 344 (2009).
The FDA restricts drug companies from directly promoting drugs for off-label uses. However, drug companies are permitted to distribute journal articles relating to off-label uses for the purpose of ‘educating’ physicians. In 2009, the FDA made a number of non-binding recommendations concerning this practice. See U.S. Food and Drug Administration, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm.
The practice of distributing journal articles reinforces the risks associated with pharmaceutical companies “ghost writing” articles published under the names of other authors in medical journals. See, e.g., Duff Wilson and Natasha Singer, Ghostwriting Is Called Rife in Medical Journals, N.Y. Times, Sept. 10, 2009, available at: http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=1&scp=1&sq=ghost%20written%20medical%20articles&st=cse.
The Regulation of Alcohol and Tobacco to Promote Public Health
On June 22, 2009, the Family Smoking Prevention and Tobacco Control and Federal Retirement Reform Act was signed into law by President Obama. Pub. L. 111-31, 123 Stat. 1776. The stated purposes of the legislation are set out in Section 3:
(1) to provide authority to the Food and Drug Administration to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products;
(2) to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products;
(4) to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products;
(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products;
(6) in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the tobacco industry;
(9) to promote cessation to reduce disease risk and the social costs associated with tobacco related diseases; and
(10) to strengthen legislation against illicit trade in tobacco products.
For more information on the new legislation see Jeff Zeleny, Obama Signs Tobacco Bill, NY Times, June 22, 2009; and Jonathan M. Samet and Heather Wipfli, Unfinished Business in Tobacco Control, 302 JAMA 681-682 (2009).
Tobacco companies have also faced some significant defeats in the courts. See, e.g., United States v. Philip Morris USA, Inc., 566 F.3d 1095 (D.C.C. 2009)(upholding broad injunction against tobacco companies entered by lower court after finding that tobacco companies had violated the RICO statute).
In Altria Group, Inc. v. Good, 129 S. Ct. 538 (2008), the Supreme Court considered whether a group of smokers’ state-law-based fraud claim concerning the marketing of “light” cigarettes was preempted by the Federal Cigarette Labeling and Advertising Act, 15 U.S.C. 1334(b). Justice Stevens, writing for a 5:4 majority, held that the smokers’ claim was not expressly or impliedly preempted by federal law or alleged FDA policy. Months after Altria was decided, the Supreme Judicial Court of Massachusetts entered judgment for the consumers in Aspinall v. Philip Morris, Inc., 453 Mass. 431 (2009), a class action suit brought against cigarette manufacturers pursuant to state unfair practices legislation.
States and localities continue to strengthen their tobacco control laws. For example, in recent years, many states have banned smoking in public places and workplaces. For more information on the legislative steps that have been taken by states to combat tobacco use, see Tobacco Law, Smoking Policy Info, American Lung Association SLATI, http://slati.lungusa.org/. The website contains links to the following topics:
· Tobacco cessation resources available in each state
· State-by-state information about existing tobacco control laws
For some recent developments in this area, see Jonathan Stempel, U.S. judge upholds most limits on tobacco marketing, Reuters U.S., January 5, 2010, available online at: http://www.reuters.com/article/idUSTRE6045SZ20100105, and Duff Wilson, Judge Orders F.D.A. to Stop Blocking Imports of E-Cigarettes From China, N.Y. Times, January 15, 2010, available at: http://www.nytimes.com/2010/01/15/business/15smoke.html.
Problem: Public Health and the Crushing Problem of Obesity
A. Obesity Taxes
There is a long history of taxing substances viewed as harmful, such as alcohol and cigarettes. Should the same taxing strategy be applied to substances that might be associated with increasing rates of obesity and diabetes?
New York’s Governor David A. Paterson initially proposed but then backed away from an 18% “obesity tax” on sugary, non-diet drinks. See Sewell Chan, Soda Tax Plan Sparks a Debate, NY Times, December 16, 2008; Nicholas Confessore, Paterson Lowers Expectations on Soda Tax, Calling Approval Unlikely, NY Times, February 13, 2009. Obesity taxes have also been raised as a possibility at the federal level. Dr. Thomas Frieden, a noted soda tax proponent, was recently appointed by President Obama to lead the Centers for Disease Control and Prevention. Sugar taxes were raised as a possible source of revenue for health care reform proposals in 2009. See David Leonhardt, “Sodas a Tempting Tax Target”, NY Times, May 19, 2009.
Sugar taxes are an example of how public health concerns may transform what would otherwise be a private, personal choice into a site for governmental regulation. Why do you think sugary beverages are being singled out as targets for special taxes? Do you think other unhealthy foods should also be the subject of ‘sin taxes’?
Are obesity taxes driven by public health goals or by economic goals? Do you think sugar taxes are meant to reduce the consumption of products that lead to obesity? Are such taxes an attempt to offset public costs created by the private consumption of unhealthy products? Or, are sugar tax proposals merely a convenient way to raise revenue for state or federal governments?
For articles discussing the benefits and risks of sugar taxes see Kelly Brownell and Thomas Frieden, Ounces of Prevention – The Public Policy Case for Taxes on Sugared Beverages, 360 N Engl J Med 1805 (2009); and Ryan Vinelli, Sugar Taxes Aren’t Sweet: The Case Against Pigouvian Taxes on Sugar-Based Drinks (May 26, 2009), available at SSRN: http://ssrn.com/abstract=1410068.
B. The Regulation/Prohibition of Trans Fats
Trans fats are created by the hydrogenation and partial hydrogenation of vegetable oils. As noted in the text, trans fats have been strongly linked to heart disease. See Fat in Margarine is Tied to Heart Problems, NY Times, May 16, 1994.
On December 6, 2006, the New York City Board of Health voted to implement a near-complete ban the use of artificial trans fats in restaurants. See Thomas J. Lueck and Kim Severson, New York Bans Most Trans Fats in Restaurants, NY Times, December 6, 2006. Other cities such as Boston have implemented similar bans. See M.E. Malone, Cooking up ways to lose trans fat, Boston Globe, February 25, 2009.
California was the first state to ban trans fats. On July 26, 2008, a law phasing out the use of trans fats in restaurants came into force. See California Bars Restaurant Use of Trans Fats, NY Times, July 26, 2008.
C. Posting Calorie Information
In New York State Restaurant Ass’n v. New York City Bd. Of Health, 556 F.3d 114 (2d Cir. 2009), the U.S. Court of Appeals for the Second Circuit considered and upheld the constitutionality of a New York City Health Code regulation that requires approximately 10% of local restaurants to post calorie information on their menus. The New York State Restaurant Association (NYSRA) had argued that the regulation violated restaurants’ First Amendment rights. The court noted that while commercial speech is entitled to First Amendment protection, it generally receives less extensive protection than non-commercial speech. Furthermore, the court stated: “regulations that compel ‘purely factual and uncontroversial’ commercial speech are subject to more lenient review than regulations that restrict accurate commercial speech” (citing Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626 (1985)). The court upheld the regulation as rationally related to a legitimate governmental purpose.