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FDA
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
Subcommittee on Health
Committee on Engergy and Commerce
United States House of Representatives
on
"H.R. 1108, Family Smoking Prevention and Tobacco Control Act."
Mr. Chairman and Members of the Subcommittee, I am Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs at the United States Food and Drug Administration (FDA or the Agency). I regret that I will not have the opportunity to appear before you at this hearing because the Committee was not able to resolve the issue of witness paneling within the allotted time for the hearing.
For the last three decades, I have been engaged in the war on cancer both professionally and personally. Throughout my professional career, I have been privileged to serve in a variety of roles with a similar purpose and commitment---to help assure the health and welfare of patients and the public. As many of you may know, I spent many years at The University of Texas MD Anderson Cancer Center as an oncologist, researcher, and educator. In my time as a practicing oncologist, I treated numerous patients suffering the ill effects of tobacco. I came to know first hand the life-threatening conditions caused by tobacco products and the tremendous suffering that is taking a toll on patients, their families and friends, and society as a whole. I then served for four and a half years as Director of the National Cancer Institute (NCI) before coming to FDA as Commissioner. Today, I sit before you as a physician, scientist, clinician, and regulator. As a three time cancer survivor, I am involved not just professionally but am personally committed to the fight against cancer and the resulting suffering and death. I am grateful for this Subcommittee’s work in minimizing the effects of tobacco use in this country.
Although tobacco use has declined in this country, its effects are so detrimental that it remains one of the most important -- if not the most important -- public health issue we face. The 2004 Surgeon General’s Report entitled, “The Health Consequences of Smoking,” noted that during the period 1995-1999, smoking caused approximately 440,000 premature deaths in the U.S. annually, leading to 13.2 years of potential life lost for male smokers, and 14.5 years lost for female smokers. The list of diseases and conditions caused by smoking has been expanded to include abdominal aortic aneurysm, acute myeloid leukemia, cervical cancer, kidney cancer, pancreatic cancer, stomach cancer, pneumonia, periodontitis, and cataract. These are in addition to diseases previously known to be caused by smoking, including bladder, esophageal, laryngeal, lung, oral, and throat cancers, chronic lung diseases, coronary heart and cardiovascular diseases, as well as reproductive effects and sudden infant death syndrome. Tobacco users face nicotine addiction, increased risk of cancer from consumption of carcinogens, increased risk of heart disease from exposure to chemicals, and lung disease resulting from inhaled irritants.
We concur with the Surgeon General’s conclusions that measures to prevent smoking initiation need to be a multiplex, integrated strategy and initiatives need to be strong and enforced, especially among adolescents and young adults. FDA must continue to work with the drug and device industries to ensure that smokers have a variety of options to help them treat the problem of nicotine addiction.
FDA is privileged to be among the other Federal and state agencies that are participating in some way to reduce tobacco use. It is clear, however, that the problem remains. We must continue to be innovative in our approaches and concentrate on achieving results.
Many agencies within the Department of Health and Human Services are working to address this major public health problem. FDA has worked to help develop and approve nicotine replacement products that help smokers quit, such as nicotine gum and patches, many of which are readily available over the counter to smokers who wish to quit. FDA has approved other drug products that do not contain nicotine that help smokers quit using other modes of action, including bupropion and most recently (spring 2006) varenicline. There are a variety of other non-nicotine containing smoking cessation products in the pipeline in various stages of development.
In addition, the Centers for Disease Control and Prevention (CDC), NCI, the Agency for Healthcare Research and Quality (AHRQ), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the National Institute on Drug Abuse (NIDA) are all actively involved in the fight to reduce tobacco use. These agencies conduct comprehensive tobacco control and prevention programs, which serve to educate the American public on the dangers of tobacco, especially American youth. They conduct surveillance and research and collaborate with public health organizations in the prevention of tobacco use and smoking cessation programs. Finally, the Office of the Surgeon General has been especially active in the campaign against tobacco use by following up the 2004 Report with subsequent studies on the health effects of exposure to second-hand smoke and other efforts.
The states are also engaged in a variety of methods to limit smoking. All fifty states have adopted legislation prohibiting sales of tobacco to individuals under 18. Many states also limit smoking in some public locations. Most state health departments run educational programs aimed at prevention and limiting the number of smokers.
Despite the numerous Federal and state initiatives, tobacco still claims hundreds of thousands of lives every year. This is unacceptable. We have the opportunity here to explore novel solutions to the lingering problem of tobacco.
FDA shares the goal of H.R. 1108, the “Family Smoking Prevention and Tobacco Control Act,” – to reduce tobacco use in this country. We agree with the need to address this significant public health problem. But we have concerns with the bill’s proposed means to achieve those objectives. The Agency has three primary categories of concern with the proposed role for FDA.
First, we have concerns that the bill could undermine the public health role of FDA. Second, we have concerns about aspects of the bill that may be extremely difficult for FDA to implement. And third, we have significant concerns about the resources that would be provided under the bill and the expectations it might create. Let me elaborate on each of those areas.
First, FDA is a public health agency, structured to facilitate and regulate the development of products that promote and protect the public health. The Agency enjoys widespread public support for its role in defining and assuring effectiveness and safety of products they consume. Our responsibility includes approving products based on scientific evidence that benefits of the product outweigh the risks. We have extensive experience in such evaluations and we have developed finely tuned methodologies.
H.R. 1108 would ask us to apply this framework to tobacco products that, when used as intended, produce disease rather than promote health. FDA cannot “approve” a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks. It will be very challenging to transform existing science into a logical regulatory structure. There is little science available to the FDA on which to base decisions on tobacco product standards (such as reducing or eliminating harmful constituents, reducing the amount of nicotine in products, or requiring changes to tobacco product components) or premarket approval.
Associating the Agency with the approval of these inherently dangerous products would undermine the Agency’s mission. Indeed, associating any agency whose mission is to promote public health with the approval of inherently dangerous products would undermine its mission and likely have perverse incentive effects. This proposed legislation would direct FDA to regulate tobacco products in a variety of ways, most significantly by the establishment of tobacco product standards, pre-market approval of new tobacco products, and standards for the sale of modified risk tobacco products. Approval of tobacco products that are dangerous to health even if used as directed runs directly counter to FDA’s historical mission to protect and promote the public health by reviewing and approving products that prevent and treat disease, not products whose only impact on health is to cause disease.
In addition, the provisions authorizing pre-market approval of new and reduced risk tobacco products are of special concern. Most fundamentally, we are concerned that FDA “approval” of tobacco products may become confused with the Agency’s regulation of therapeutic products such as drugs and devices. For example, the bill provides potential loopholes for “grandfathered” and “substantially equivalent” products, which will be permitted to stay on the market. We are concerned that the public will believe that products “approved” by the Agency are safe and that this will actually encourage individuals to smoke more rather than less.
As another example, the bill would attempt to apply current requirements for medical products such as drugs and medical devices to tobacco products. These include adverse event reporting, adulteration and misbranding, and record keeping. These concepts are not applicable to inherently dangerous tobacco products. One example of the awkwardness of applying medical product standards to tobacco products is contained in the bill’s definition of an adulterated tobacco product. Section 902 of the bill provides that a “tobacco product shall be deemed to be adulterated if—‘(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health.’”
Tobacco products, however, are intrinsically injurious to health, i.e. adulterated according to this definition. This concept, therefore, does not fit when applied to the regulation of tobacco products. There are other examples in the bill where similar problems would arise.
The bill also appears to call for FDA to perform functions that are outside of the Agency’s expertise, including, for example to investigate and prevent cigarette smuggling.
The final issue of concern that I would like to discuss today is that of resources and expectations under this bill. As I am sure you are all aware, FDA is operating in a dynamic time. We are striving to meet new challenges. Just last week, the President signed the Food and Drug Administration Amendments Act of 2007 that will allow us to continue to evolve and undertake our mission of protecting the public health. Were H.R. 1108 enacted, FDA would need to create an entirely new “tobacco center” to implement the detailed program created by the bill.
By far, the most important and daunting challenge would be to develop the expertise necessary to carry out the functions called for by this bill. FDA does not have expertise regarding customarily marketed tobacco products and, therefore, would have to establish an entirely new program and hire new experts. Creating the appropriate organizational structure and hiring experts in the field of tobacco control and related sciences and other experts needed to staff the program at every level is considerably more challenging than simply filling identified vacancies in an existing program.
The provisions in this bill would require substantial resources and FDA may not be in a position to meet all of the activities within the proposed user fee levels. The $85 million in fiscal year (FY) 2008, $175 million in FY 2009, $300 million in FY 2010 and subsequent years of user fees adjusted by an inflation factor, is not sufficient to implement the complex program created by the bill. In addition, the bill does not authorize appropriations for start-up costs that would be associated with establishing a new product center. As a consequence of this, FDA may have to divert funds from its other programs, such as addressing the safety of drugs and food, to begin implementing this program.
Finally, FDA also would need a considerable amount of time, to implement the program created by the bill. The legislation authorizes or requires the Agency to publish numerous regulations and other documents.
The bill also requires the Agency, in a short timeframe, to issue a regulation originally published in 1996 that relies on data and information that are a decade old and would need to be updated to reflect the latest science. Many of the timeframes provided, ranging from 30 days to 2 years after the bill is enacted, are unworkable especially considering the expectation that we produce these documents while we are creating an entirely new program from the ground up. These timeframes unduly and unfairly raise the public’s expectations about what the Agency could accomplish in a given period of time. In the best of circumstances when scientific results point to a clear regulatory approach, rulemaking typically involves at least a three-year process. In situations where the science is less fully developed or the issues are complex or controversial, and both are the case here, regulation development requires much more time.
I share with you the desire to reduce tobacco use in America. FDA believes it can continue to contribute to the decline in tobacco use in keeping with its primary mission by facilitating access to smoking cessation programs and therapies that have evidence of effectiveness, and by supporting sponsors who choose to pursue the development of these products. However, FDA is open to considering other roles for the Agency, if appropriate. Let me assure you that FDA is committed to joining you and other government and private organizations in efforts to minimize the devastating effects caused by tobacco use in a manner consistent with the Agency’s mission.
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