December 30, 2013
Advisory Committee Oversight and Management Staff
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 32, Rm. 5103
Silver Spring, MD 20993-0002
Via email to email@example.com
Dear Members of the Advisory Committee Oversight and Management Staff:
On behalf of The Consumer Advocates for Smoke-free Alternatives Association (CASAA), I am writing to nominate Carl V. Phillips, PhD, as a voting member of the Tobacco Products Scientific Advisory Committee (TPSAC). Dr. Phillips, who serves as CASAA’s Scientific Director (an unpaid position), is aware of this nomination. His CV is attached (it does not including his home address, which is ________ or CASAA’s business address, which is 7481 Huntsman Blvd, #420, Springfield, VA 22153).
CASAA is a non-profit 501(c)(4), all-volunteer organization with a grassroots membership of thousands of individuals from all walks of life. We are a consumer advocacy organization, not a trade association or industry representative. CASAA is dedicated to ensuring the availability of reduced harm alternatives to smoking and to providing smokers and non-smokers alike with honest information about those alternatives. Since CASAA's founding in 2009, we have educated the public and increased awareness about the benefits of reduced harm alternatives to smoking, including e-cigarettes. We also encourage responsible legislative policy designed to improve public health by recognizing that smoke-free nicotine-containing products are inherently far less dangerous than smoking.
We believe it would be ideal for Dr. Phillips to hold the consumer representative slot in the TPSAC, though we are nominating him for any available opening. As outlined below, he is highly qualified as both a scientific advisor and a consumer representative, and would be able to serve both roles whichever seat he occupied.
Dr. Phillips offers a unique combination of skills and viewpoints for the TPSAC. He is a consumer advocate and would be the first member of TPSAC who primarily represents the consumers, the primary stakeholder in this process. As CASAA and others have repeatedly communicated to FDA’s Center for Tobacco Products (CTP), the CTP in general and the TPSAC in particular is not fulfilling the “nothing about us without us” principle. The consumer voice has been limited to submitted comments while industry, tobacco control activists, and researchers have been members of TPSAC and invited presenters at open and closed meetings. The current supposed consumer representative on TPSAC is a hard-core tobacco control activist whom many consumers of tobacco products would consider a perfect example of an active enemy of their interests, not a representative of them.
Dr. Phillips has been a tireless consumer-focused advocate for tobacco harm reduction for more than a decade. While his approach to the field has been primarily as a scientist, as discussed below, he has long been one of the leading educators of consumers, originally through his TobaccoHarmReduction.org website at the University of Alberta (which still exists as an archive and is still used as a consumer resource despite being somewhat dated) and associated publications. (Though he did much of his work on this topic as a professor inCanada, he is an American citizen and has permanently returned to living in the USA.) He has strong respect in the organized community of e-cigarette users and among those smokeless tobacco users who are politically organized. He frequently tops the lists of “who are the best consumers advocates” in these areas. He is a Director of CASAA, the largest tobacco product consumer advocacy organization, and has strong ties to other consumer advocates.
Additionally, while Dr. Phillips has spent most of his professional career trying to reduce smoking by encouraging harm reduction, he is one of the few scientists working on harm reduction who has maintained the respect of smokers and smokers’ rights advocates, because he has regarded them as people who might be persuaded rather than objects to be manipulated. Thus, he is probably the best representative for the majority stakeholders in the CTP process -- the tens of millions of American smokers -- that the TPSAC could include. It is difficult to balance the need to represent consumers of the deadliest form of tobacco use with the goal of reducing the health burden this consumption creates; Dr. Phillips might be the only person who brings that balance.
On the scientific side, Dr. Phillips is one of the leading researchers on tobacco harm reduction and among those who have been working on the topic the longest. His technical bona fides include earning doctorate and completing postdoctoral studies, being a professor of public health for most of his career, numerous academic papers and presentations, serving on scientific committees, and serving as a journal editor and editor-in-chief. He is an award-winning epidemiologist, as well as being a published researcher in policy analysis, economics, survey research, statistics and complex data analysis, risk analysis, and computer modeling. He is currently working in the latter area to develop a population model of consumer choice among tobacco products, work he has twice presented to the CTP over the last few months. In addition, he has scientific literacy in the tobacco-related areas of chemistry, pharmacology, toxicology, clinical research and evidence-based medicine, sociology, and political science. His original training, as well as the bulk of his teaching as a professor, was in the intersection of science and policy that is now often called “regulatory science,” science-based policy-making and how to conduct science to best inform policy.
Dr. Phillips is also knowledgeable about the various tobacco product industries, across all sizes of business and product categories. He has spent years in communication with them and has been a sought-after industry advisor. While some would consider this association a liability, we believe it is an additional asset. He would bring to TPSAC a deep understanding of industry, but not from the perspective of industry. He is an unhesitating critic of industry, and so it should be clear that he is not their apologist; he works with industry when it is in the interests of consumers or better science, not because he supports any particular company or the industries in general. He has received research and consulting funding, but it may be useful to note that his current funding from industry, as well as the vast majority of his past funding from industry, is unrestricted research grants, wherein the funder has no control over how he chooses to conduct his research or the results thereof. Moreover, he has indicated a willingness to refrain from any formal consulting for industry while a member of the TPSAC to the extent that this is a requirement for the position.
Finally, Dr. Phillips is very familiar with the TPSAC process. He has closely followed the activities of the CTP and the TPSAC since their creation, has attended many of the public meetings, and has led efforts to organize consumer responses to the CTP. We realize that Dr. Phillips is a rather outspoken advocate for consumers and for good science, but it is important to realize that he is also a consummate professional and team player. As anyone who has worked closely with him can tell you, he is an effective member of a committee, working for the good of the organization while not compromising his views and values.
The CTP has repeatedly communicated to CASAA and to the world (e.g., in Director Zeller’s webinar on December 11, 2013) that they are serious about increasing and formalizing the consumer voice in the CTP process. There seems to be an understanding of the “nothing about us without us” principle that FDA subscribes to in their other regulatory areas. We can imagine no way to take concrete action on this promise that would be nearly as effect as appointing Dr. Phillips to the TPSAC.
President, The Consumer Advocates for Smoke-free Alternatives Association (CASAA)