Here is Scott Ballin's testimony for Dec 17 FDA hearing.
Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW Washington DC 20015
Tel: 202 686-8898 Mobile 202 258-2419
email:
ScDBa@aol.com
I greatly appreciate the opportunity to be able to submit this statement to the Food and Drug Administration in response to the Federal Register Notice:
Docket No. FDA-2012-N-1148: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence.
The hearing and the agency's request for comments represents a very important step forward in what must be a more serious and on-going discussion about how ALL tobacco, nicotine, and alternative products should be regulated in a more consistent manner. The series of questions that the FDA has outlined actually raise more questions that need to be addressed in considering future policy decisions- not only within the agency but in Congress as well. While addressing some of the questions presented in the Federal Register Notice, I plan to broaden the discussion by suggesting a number of areas, topics and issues that need consideration.
I Putting Section 918 (as well as other sections of the FSPTCA) into an Historical Context -- The Need to Look to the Future and Not Try to Perpetuate the Past
II Definitions and Terminologies
III Why is the consumer always seemingly left out of the discussions?
IV What Can FDA and Congress Do to Bring Tobacco, Nicotine and Alternative Products Regulation into the 21 Century? Isn't it time to bring all tobacco, nicotine and alternative products under a single regulatory umbrella?
V Observations and Recommendations
I Putting Section 918 (as well as other sections of the FSPTCA) into an Historical Context -- The Need to Look to the Future and not Try to Perpetuate the Past
Up until a little over three years ago traditional 'tobacco' products were for the most part unregulated by any governmental agency and what regulation there was tended to be piecemeal. Products that were attempted to be put on the market that were somewhat different or 'innovative' were often prohibited because the 'tobacco' in them made them 'adulterated' or because they made some therapeutic type claim.
It forced nicotine products such as NRT (from which the nicotine was and still is derived from tobacco) to be developed through the drug and device regulatory channels. That scenario which existed for several decades, really perpetuated a public health challenge, giving us an environment in which cigarettes - the deadliest (and most efficient) form of nicotine delivery thrived and remained protected from regulation at the expense of allowing and/or encouraging potentially lower risk products to be developed and marketed. That schizophrenic environment gave us the 'low tar and low nicotine' debacle which by all accounts from a public health standpoint turned out to be a disaster. While in some ways NRT was at a disadvantage in that these products were subject to FDA regulations (that cigarettes were not) that restricted dosage, required extensive labeling, product size, controls over sales and marketing etc. these products also had an advantage over other products due to costs, and other barriers.
As long as cigarettes remained outside of the FDA's purview the pharmaceutical companies retained a unique competitive advantage for the sale, distribution and marketing of what were not only smoking cessation products but in today's environment might better be referred to as 'harm reduction' products. But that is changing, and changing rapidly.
The scenario that existed for so many years was also in many ways a lose-lose situation perpetuating an imbalanced system that was not always based on science or product comparisons, but on 'war' -- that included rhetoric, legal and legislative maneuverings by and with Big Tobacco.
In the last ten or so years however (things do move slowly) and in spite of efforts by some in industry, tobacco control, policy makers, governmental agencies, and even the media to keep the 'war' of the 1980's and 90's going, change has been and is continuing to take place. Today's environment is a radically altered one demanding new ideas and consideration of how we regulate all tobacco, nicotine and alternative products with greater consistency and based on risks, relative risks, and intended uses—keeping in mind there are new opportunities for reducing the disease and death toll caused by the use of tobacco products. New products (whether tobacco, nicotine or alternative products) , new manufacturers and most importantly new science, technologies and innovation are forcing a discussion on the need for policy changes that should have taken place some years ago.
For decades, pharmaceutical interests have also given much financial support to the tobacco control community, NGO's, and the research community, providing significant resources for combating smoking, sponsoring conferences, developing 'cessation programs' and 'quit lines', developing joint lobbying strategies, funding research, and filing complementary petitions to agencies such as the Food and Drug Administration. These were all commendable initiatives especially during a period when there was no oversight over traditional tobacco products. After years of effort and work and in spite of tremendous opposition from some Big Tobacco companies (Altria/Philip Morris broke ranks with the other companies to support the legislation), the Tobacco Control Act was finally enacted and while much of the Act is meritorious, other provisions of the Act were destined to become 'outdated' as soon as the President signed it into law. With enactment of the new law we entered a 'new era' which many it seems are finding difficult to accept.
Congress, as it often does, laid out a series of mandatory deadlines for the FDA. The FDA should be commended for making a concerted effort to meet deadlines in such a short period of time. The Section 918 report is one of those mandatory obligations. But the time and energy spent on meeting these mandatory obligations has also prevented the FDA from doing some 'out of the box' thinking that is so needed in developing a more workable, coherent and rational national tobacco and nicotine policy.
Smoking has been and should for the moment remain the primary concern to public health (but not the only one) as it accounts for over 400,000 deaths in the US and millions globally. The primary focus of the pharmaceutical industry efforts were (and still are) focused on smoking and not on tobacco or nicotine per se. Let's not forget that one could argue that nicotine replacement (NRT) products that do not make a therapeutic claim could be classified as 'tobacco' products in today's environment.
While we often use the word tobacco, it is really the toxic 'cigarette' and the chemicals found in the smoke that causes the serious damage from tobacco use. Change the product and you can change the risk. There are significant differences in the level of risk between the spectrum of tobacco, nicotine and alternative and innovative products. Governmental agencies, tobacco control advocates, NGO's, and the media often make sweeping all inclusive statements such as 'tobacco accounts for the deaths of over 400,000 Americans each year' ---- an accurate statement but misleading and certainly one that is not very scientific or specific. This isn't just about there being two categories of products-- nicotine and tobacco, but about a growing spectrum of products—all having differing levels of risks. The reality is that it is the combustible cigarette that causes the overwhelming majority of the premature deaths. It would be like saying automobiles kill or having sex causes STD's, using alcohol kills both the user and nonuser, or eating meat will cause cardiovascular disease and strokes*. All true but not very specific or useful to those seeking to reduce harm.
* It is of some relevance that a meat (ham) that I often consume called 'Healthy Ones' carries the American Heart Associations CHECK for being 'extra lean' with a further statement , "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease". Could similar approaches and thinking be used by the FDA to convey information (labeling and educational programs) to consumers about the risks, relative risks and uses of nicotine, tobacco, and alternative products? I think they could.
We need to accept that its not the tobacco per se that causes the significant harm but rather how that tobacco had been grown, processed, cured, manufactured and most critically used that causes the harm. Nor is it the nicotine that causes the significant harm, although many in the public erroneously believe that it is.
Tobacco is being researched to develop new medicines and industrial enzymes and is often called the 'white rat' of the plant world. Such research may also yield new innovative products that might be used in the development of smoking replacement products. Simply attacking ‘tobacco’ simply misses the point.
CDER's consideration of long term nicotine use as a means of smoking cessation and the issues raised in Section 918 are obviously interrelated and should be considered in the broader context of a changing tobacco, nicotine and alternative products regulatory environment. NRT ended up under CDER's purview because there was no other place to put it. Today there is. ** Many have suggested that NRT is very different than other more traditional prescription/pharmaceutical products. I would agree with that assessment.
We therefore need to rise above the constraints and limitations of the statute, dispense with the rhetoric on the 1990's, as well as the protracted discussion of long term nicotine use and begin serious dialogue about the need for establishing a more rational,
uniform and coherent regulatory policy governing all tobacco, nicotine and alternative products --- a regulatory structure based less on who the manufacture is and more on the product itself. (See below).
The issues being raised by Section 918 are important but they are in part based on a 'past era' and also reflect the influence of pharmaceutical interests in an effort to retain and maintain a competitive advantage and to discourage the development of new lower risk products that could//should include tobacco based products. This is/was also the case for Section 911 concerning modified risk tobacco products, where the bar has been raised so high that it discourages the development of innovative lower risk tobacco products. In deciding how to develop a more flexible regulatory policy for nicotine/NRT type products consideration must also be given to allowing a more workable policy with respect to other products even those containing tobacco.
**A younger generation may not remember that in the 1990's a concerted effort was made by health groups (Coalition on Smoking OR Health) and the FDA to 'level the playing' by bringing cigarettes under FDA's drug and device authorities (since no separate authorities existed for tobacco) and to therefore regulate all tobacco and nicotine products in a more rational and consistent manner. The US Supreme Court eventually ruled that FDA did not have jurisdiction. Today we have the Center for Tobacco Products and it is logical that all tobacco and nicotine products should now be regulated under a single regulatory umbrella through the CTP.
As FDA notes (page nine of the Federal Register Notice) one of the basic questions (and in my mind the most critical for the future) that needs to be addressed in its report to Congress(and in my mind the most critical to the future of public health) is:
"how best to regulate, promote, and encourage the development of 'innovative products and treatments." (whether nicotine based or non-nicotine based)
As part of those considerations FDA (and Congress for that matter) might want to revisit the Institute of Medicine's landmark report, Clearing the Smoke. That was a report requested by the FDA and unfortunately virtually ignored when the writing of the FDA tobacco statute took place (I could not find a single reference to the report in the Findings of the legislation).
In that report which focused on tobacco, nicotine and other potential alternative products the IOM made the following recommendations:
- Manufacturers have the necessary incentive to develop and market products that reduce exposure to tobacco toxicants and that have a reasonable prospect of reducing the risk of -tobacco-related disease;
- Consumers are fully and accurately informed of all of the known, likely, and potential consequences of using these products;
- Promotion, advertising and labeling of these products are firmly regulated to prevent false or misleading claims explicit or implicit;
- Health and behavioral effects of using PREPS are monitored on a continuing basis;
- Basic, clinical and epidemiological research is conducted to establish their potential for harm reduction for individuals and populations; and
- Harm reduction is implemented as a component of a comprehensive national tobacco control program that emphasizes abstinence orient prevention and treatment.
II Definitions and Terminologies
As I reviewed the Federal Register announcement I was, as I have been for a number of years now, struck by just how in need we are of refining and redefining the terms that we use in the tobacco and nicotine environment. Government agencies, NGO's and others use terms loosely and interchangeably. In a regulated environment there should be clearer definitions and understanding of the terminologies that we use. A reexamination of such terms needs to be conducted. Here are just a few of the questions I would suggest be addressed.
- What is a tobacco product?
- What is a smokeless tobacco product?
- What is a nicotine product?
- What is a nicotine replacement therapy? Should we be talking about and considering 'smoking replacement products' instead, that include a broader spectrum of products-- both nicotine and tobacco?
- What is an 'innovative' product? Can an 'innovative' product be a tobacco based product?
- What is 'cessation'? ------ 'smoking cessation?, tobacco cessation?, nicotine cessation?
- Is abstinence different than cessation? Abstinence from what ? -- smoking? ,tobacco? nicotine?
- What is 'relapse' ? Relapse from what to what?------ Smoking? Tobacco use? Nicotine?
- Are there distinctions to be made about how 'claims' might be classified depending on the level of science available about a particular class of products as well as a specific product? Can FDA, as is done with foods, develop a more consumer friendly system for the allowance of a variety of claims, including truthful and accurate information?
- What is a tobacco company? Can a tobacco manufacturer also be a pharmaceutical company? Or vice versa? Are there differences between the more traditional tobacco manufacturers (Big Tobacco) and new technology oriented companies that are doing research and developing new products? Some of the more traditional tobacco companies (Big Tobacco) are expanding their portfolios to include nicotine products as well. Does it matter in this day and age of regulatory oversight, where the focus should increasingly be on the product and less on who the manufacturer is?
- How should 'harm' or 'harm reduction' be defined? Should the 'cigarette' be used as the reference product by which the harms of all tobacco, nicotine and alternative products are assessed?
- How should 'risk', 'relative risk' be defined for tobacco, nicotine and alternative products? Should we be focusing on establishing 'risk profiles' for the spectrum of products along the continuum of risk?
- What is the public health goal? Is it reducing disease and death caused by the use of harmful tobacco products (i.e. one that incorporates a harm reduction strategy)?' Or, is it eliminating all risks (regardless of how negligible) including advocating prohibition of all tobacco, nicotine and alternative products? Could trying to achieve abstinence do more harm than good?
III Why is the consumer always seemingly ignored in the discussions?
I have been working and involved in tobacco control and public health for over three decades and it amazes me to this day that we have not done a very good job of involving the consumer in the discussions. We all seem to know what's best for them. Yet, many surveys of the public and consumers using both tobacco and nicotine products have shown that there is a deep lack of understanding and confusion about these products. Many think that noncombustible products are as harmful as or even more harmful than cigarettes. Many also believe that NRT products such as nicotine patches, gums, and lozenges are as harmful as using cigarettes and cause cancer and other diseases.
While the issues that I have been raising in this submission will need to be considered by a spectrum of interests, the consumer's interest needs to be seriously taken into account and FDA should look at other models it has used in the food and drug arenas where the agency has often involved consumers in the discussions.
IV What Can the FDA and Congress Do to Bring Tobacco, Nicotine, and Alternative Product Regulation into the 21st Century? Isn't it time to bring all tobacco, nicotine and alternative products under the same regulatory umbrella?
I have suggested that serious consideration needs to be given to bringing all tobacco, nicotine and alternative innovative products under a single regulatory umbrella at the FDA
At several of FDA/TPSAC, CTP and CDER meetings I attended and participated in, I noticed that some of the members, participants etc. were starting to get beyond the rhetoric and raising questions, trying to get a better handle on how products should be defined and classified including some acknowledgments that there are inconsistencies and questions about how the law might be applied to the growing spectrum of tobacco and nicotine products on the market. E-cigarettes are one example, but so are lozenges, inhalers etc.
A couple of years ago when CDER held its workshop on long term nicotine use, the topic would often shift to the issue of tobacco based products, even though CDER did not have jurisdiction over tobacco.
The same can be said of many of CTP's meetings where the discussion of tobacco would often drift and shift to issues related to NRT etc.
The establishment of a more rational, balanced, and flexible approach to regulating all tobacco, nicotine and alternative products would bring some predictability to the environment, serve the interests of public health, promote competition and reward those, whoever they might be, who produce significantly lower risk science -based products whether they are tobacco based, nicotine based or even some alternative.
I am suggesting (and that the FDA do so in its report to Congress) that the current Center for Tobacco Products (CTP) at the FDA be renamed the Center for Tobacco, Nicotine and Alternative Products ending the anachronistic system that puts some products in CTP, others at CDER and still others in limbo. I am suggesting that by doing this, not only does the FDA's job become somewhat easier but it gives manufacturers of any of the spectrum of products a better road map. Consumers too benefit because for the first time there would be some consistency in how these products relate to one another, how they are labeled and how they would be marketed.
I am also suggesting that within this expanded and consolidated Center that there might be three regulatory review panels --
- one for combustible products;
- one for non-combustible products(which I call Smoking Replacement Products (SRP's) and;
- one for therapeutics making disease specific related health claims.
Scientific evidence would be used to determine how these products would be labeled and marketed. I don't think it is too far fetched that a tobacco based product might one day have the same kind of therapeutic profile as does an NRT product currently on the market or that an NRT product on the market that doesn't make a therapeutic claim would be classified sold and market as a tobacco product.
Monitoring and surveillance across the broad spectrum of products would provide the FDA with a clearer view of who is using the various products and why and give the agency greater flexibility in working with manufacturers and others in the tobacco and nicotine marketing chain, as well as helping design more effective educational campaigns.
I believe that:
REGULATION + Science + Competition + Innovation + Incentives can be a very effective way of not only promoting and protecting public health but in changing the behaviors of manufacturers as well.
V Observations and Recommendations
There is a lot of work to be done both in the public and private sector. The issues and questions being raised (not only by Section 918 but sections like 911 as well) need to be aired and more fully discussed. The rhetoric that has dominated (and continues to dominate) the tobacco and nicotine environment must be toned down. FDA needs to take a leadership role. Leadership does not mean 'hiding' behind the statute or merely checking off the boxes on accomplishments. It should also entail looking at new opportunities for developing a more rational and workable regulatory system for all tobacco, nicotine and alternative products.
- FDA can begin by conveying to Congress in its report that a more uniform, coherent and comprehensive regulatory structure is needed governing all tobacco, nicotine and alternative products. This should include consideration of bringing these products under a reconstituted "Center for Tobacco, Nicotine and Alternative Products";
- FDA should convey to Congress that this more uniform approach to regulating all tobacco, nicotine and alternative products should be based on risks, relative risks and intended uses of each product (including categories);
- FDA should convey to Congress that outdated definitions and terminologies for all tobacco, nicotine and alternative products need to be updated both from a legislative/regulatory point of view and in helping the public better understand the risks, relative risks and intended uses of the various products on the market;
- FDA needs to independently convene an 'open educational meeting' of governmental agencies interested in the issue of tobacco and nicotine regulation that includes not only offices within FDA, the NIH, CDC, IOM etc but also the USDA and EPA. Such a meeting should also include public and private 'experts' familiar with labeling, and marketing issues and who are not only focused on the tobacco issue but who would bring added value to the discussions. There is much to be learned about how products should be developed, labeled, and marketed, and monitored from such experiences in the food and over the counter drugs (OTC) arenas. This includes how the spectrum of products can and cannot make claims (informational or health); how consumers receive and interpret labeling and marketing messages etc.; and what kind of 'educational' efforts should be designed and conducted to provide the public and users of these products with 'truthful, non- misleading' and understandable' information.
- A more open and transparent discussion should also include such issues on how to provide 'incentives' for new product development as well as removing barriers to the development of new innovative tobacco, nicotine and alternative products. Competition should be encouraged not suppressed in this new regulatory environment. One such 'incentive' might be consideration of establishing a system in a restructured CTP for fast-tracking products where there is a substantial degree of science and consensus to allow the approval for such products. This fast-tracking process could be based on FDA's Section 506 but at the same time be tailored to issues specifically related to tobacco, nicotine and other innovative products. Another might be to levy a 'risk -profile' tax on the highly toxic products or give tax credits to those products that are significantly lower in risk.
- Congress should be encouraged by the FDA to hold serious (not political or partisan) oversight hearings on how to develop a more workable, flexible and uniform statutory/ regulatory system governing all tobacco, nicotine and alternative products without micromanaging the agency's work ---- i.e. set the parameters and let the FDA and the public and privates sector do their work in this dynamically changing environment.