July 12, 2017

CONTACT: Karen Teber / km463@georgetown.edu

WASHINGTON (July 12, 2017) A novel project led by the O’Neill Institute for National and Global Health Law, and funded by The Greenwall Foundation, will develop the most ethically appropriate, legally viable interpretations of a critical eight-word phrase in the Federal Tobacco Control Act, in addition to other related passages.


The 2009 act generally empowers the U.S. Food and Drug Administration to issue new tobacco control rules or otherwise regulate tobacco products and their marketing whenever the agency determines. The act mandates that FDA’s action not be “arbitrary or capricious,” and that actions be “appropriate for the protection of the public health,” the primary phrase of focus for this project.  


By applying extensive and diverse ethical and legal expertise to the question of how the public health and evidentiary standards in the Tobacco Control Act could best be interpreted and applied in different situations, the project will provide important new insights and analysis to support FDA’s tobacco control efforts.  It will also directly inform the courts when they consider any tobacco industry claims that certain FDA regulatory actions do not comply with those statutory standards.


“Although there are numerous court rulings explaining what ‘arbitrary and capricious’ means in different situations, neither the statute nor legislative history, FDA rules or guidance, or court rulings have yet explained exactly what ‘appropriate for the protection of public health’ means in this context or how it should be applied,” says project co-leader Eric N. Lindblom, director of Tobacco Control and Food & Drug Law at the O’Neill Institute.

“How this phrase is specifically defined by FDA and, ultimately, the courts will have enormous ramifications for how quickly and easily the FDA will be able to move to prevent and reduce the massive harms and costs caused by tobacco use,” explains project co-leader and Georgetown University professor Lawrence O. Gostin, faculty director at the O’Neill Institute.


“While ‘appropriate for the public health’ might seem easy to understand,” Lindblom says, “it needs to be defined precisely so that FDA knows how much supporting evidence it must have, and how certain it must be about likely public health benefits and other impacts before it can take action and, if necessary, successfully defend its actions against tobacco industry legal attacks.”


“Defining ‘appropriate for the protection of the public health’ in this context is trickier than it looks,” Gostin explains.  “For example, would it be ‘appropriate’ for FDA to take action to significantly reduce the death toll from smoking if doing so would also sharply increases the total number of youth and non-smokers who begin using tobacco or electronic cigarette products, even if less harmful ones? Can it be ‘appropriate’ for FDA to implement a tobacco control rule when available research indicates it has only a fifty percent chance of substantially reducing tobacco deaths and harms?  Are such possible impacts as increasing illicit trade, reducing tobacco industry profits, or eliminating jobs relevant to whether an FDA rule is appropriate for the protection of the public health? These are the kinds of important ethical questions that this project will answer.”     


Lindblom and Gostin have assembled a team of experts in bioethics, public health ethics, statutory interpretation, and tobacco control policy and research, medicine, and law to help guide this project, including Ronald Bayer, PhD, from the sociomedical sciences department at Columbia University; Bruce Jennings, MA, from the department of health policy and center for biomedical ethics and society at Vanderbilt University School of Medicine; Timothy M. Westmoreland, JD, from Georgetown University Law Center; Dorothy Hatsukami, PhD, Masonic Cancer Center, University of Minnesota and professor of psychiatry; and Matthew L. Myers, JD, president of Campaign for Tobacco-Free Kids.

“This project will directly address the fundamentally ethical aspects of the Tobacco Control Act’s public health and evidentiary standards,” Lindblom adds. “It will not only provide important new perspectives for FDA and the courts, but should also help to prevent efforts by the tobacco industry to establish much more restrictive interpretations that would hinder FDA efforts to reduce the horrible toll of death, disease, and other harms caused by the tobacco companies’ addictive and deadly products.”


“The Greenwall Foundation is pleased to support this bioethics research, which will provide practical ethical guidance for how the FDA can implement the Tobacco Control Act in an evidence-based, legally rigorous manner and thereby carry out its legal mandate to protect the public health,” said Bernard Lo, president and CEO of The Greenwall Foundation.


“We greatly appreciate the Greenwall Foundation’s support,” Gostin adds.  “We think this project is a perfect example of how bioethics can be applied to real-world legal and policy issues to provide extremely helpful new analysis and guidance.”  


The O’Neill Institute for National and Global Health Law at Georgetown University Law Center is the premier center for health law, scholarship, and policy. Its mission is to contribute to a more powerful and deeper understanding of the multiple ways in which law can be used to improve the public’s health, using objective evidence as a measure. The O’Neill Institute seeks to advance scholarship, science, research, and teaching that will encourage key decision-makers in the public, private, and civil society to employ the law as a positive tool for enabling more people in the United States and throughout the world to lead healthier lives.