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Summary
Pages 1-20

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From page 1...
... Summary Smoking is the leading cause of preventable morbidity and mortality in the United States, contributing to approximately 443,000 premature deaths each year nationally (CDC, 2008)
From page 2...
... benefit the health of the population as a whole, taking into account both users and nonusers of the product. Under the Special Rule for Certain Products, the Secretary of HHS may issue an order for the sale of a reduced-exposure product for which there is inadequate long-term epidemiologic data to support a finding under the Modified Risk standard but where the available evidence dem onstrates that a substantial reduction in morbidity and mortality is "rea sonably likely." In regard to both standards, the law further specifies that the Secre tary should also take into account how the marketing of the MRTP affects the likelihood of current users continuing tobacco product use with an MRTP who otherwise would have quit, nonusers initiating tobacco use with an MRTP, and the risks and benefits compared to other smokingcessation products.
From page 3...
... . While it is essential to address BOX S-1 Statement of Task The Institute of Medicine will establish a committee of 15 public health and medical experts to advise the Food and Drug Administration on the minimum standards for scientific studies to support the marketing of modified risk tobacco products and for postmarket studies of approved products.
From page 4...
... Rather, the committee sought to provide enduring insights into what constitutes credible and meaningful evidence of the effect of tobacco products on public health. The committee's insights can be generally organized into three categories: 1.
From page 5...
... , provide data that can support the strong inferences about the effect of an MRTP on human health relative to conventional tobacco products. The use of appropriately designed clinical trials will be important to establish whether the use of the MRTP reduces exposure to toxicants or induces positive changes in surrogate markers as claimed by the manu facturer.
From page 6...
... A wide variety of outcomes can be evaluated in the same study, including both intermediate and clinical outcomes. In addition, other epidemiological study designs will be necessary to evaluate MRTPs and provide evidence on the public health effects of marketed MRTPs; these include retrospective cohort studies, case-control studies, crossover or case-crossover designs, and comparative effectiveness research methods.
From page 7...
... Evaluation of the abuse and addiction potential of a product can be accomplished with a variety of experimental designs and in a variety of contexts, including subjective evaluations in laboratory contexts, acute self-administration studies in laboratory contexts, use in extended resi dence facilities, and natural environment contexts where long-term use can be studied in real-world circumstances via RCTs, cross-sectional survey studies, and longitudinal cohort studies. Evaluation of reinforcement value in a laboratory setting is particularly important because the results of these studies reliably correspond to an agent's addictive potential in real-world use.
From page 8...
... Studies evaluating risk perceptions and risk communication should be performed both before the marketing of an MRTP and after the MRTP has been marketed. Premarket research will play an essential role in developing the messages the tobacco industry can use to communicate information about MRTPs to consumers.
From page 9...
... tobacco use • Consistency of findings across relevant subpopulations of interest (e.g., low socioeconomic status, racial/ethnic minorities) Modeling and • Population predictions show reduction in smoking-related synthesis morbidity and mortality following the introduction of an MRTP with no significant evidence of uptake by nonusers (especially adolescents)
From page 10...
... The portfolio of evidence brought to the FDA to justify a modified risk or modified exposure claim will be substantial. To inform regulatory decision making, the FDA will need to process the evidence at a higher level, beyond merely amassing the evidence in support of the MRTP claims.
From page 11...
... The FSPTCA recognizes this, giving the Secretary of HHS authority to require product sponsors to compare their product to a commercially marketed representative product. The choice of appropriate comparison products will be driven by the type of MRTP being tested, the anticipated claim, and the study design.
From page 12...
... This history and the lack of trust may prevent independent experts from participating in research on tobacco products and therefore may impede the production of data on MRTPs necessary to assess public health impact. Particularly important illustrations of the lack of public trust include the fact that many major universities have bans on the acceptance of tobacco industry funding, and that many journals will not accept or publish research supported by the tobacco industry.
From page 13...
... The history of deceptive behavior by the tobacco industry undermined the trust of the public as well as the public's confidence in the industry's ability to rigorously conduct studies that will generate the data needed to evaluate these products. Therefore, the committee's recommendations are designed to articulate the minimum standards for producing credible and reliable evidence to demonstrate that the marketing of an MRTP is consistent with the protection of public health.
From page 14...
... The public health standard articulated by the FSPTCA requires collection of scientific evidence from a wide range of disciplines and research domains. Although the committee respects the FDA's independence and discretion in regulating MRTPs, the committee maintains there is a minimum range of research domains required to evaluate the effect of MRTPs on individuals and public health.
From page 15...
... Also, these methods can provide reliable evidence on human exposure. Recommendation 3: The FDA should require randomized controlled trials in the following domains: • Exposure reduction • Self-administration of the MRTP • Effects on use of conventional tobacco products These randomized controlled trials should include multiple comparison products (such as nicotine replacement products, conventional cigarettes or smokeless tobacco, placebo preparations, and alternative nicotine delivery systems)
From page 16...
... To have regulatory usefulness, studies of MRTPs must be generalizable to the overall population of interest and to specific populations, including populations at high risk for tobacco use. Failure to include relevant populations in studies will result in incomplete evidence on the effect of an MRTP on the public's health and, therefore, will be inadequate to support regulatory decisions about the marketing of MRTPs.
From page 17...
... A significant amount of guidance on minimum standards for scientific studies directly relevant to the evaluation of MRTPs has already been developed. Guidelines for formatting, design, conduct, and reporting of science are articulated in consensus statements, such as the Consolidated Standards of Reporting Trials (CONSORT)
From page 18...
... The consequence of this isolation is a lack of the expertise and the resources necessary to produce high-quality science across the range of disciplines to support an applica tion to market an MRTP. Use of a trusted third party, particularly for products developed by the tobacco industry, could provide an avenue for the production of credible evidence needed by the FDA to evaluate tobacco products.
From page 19...
... The FDA has the tools to ensure studies adhere to established standards in the drug development framework, which can be applied to the development of MRTPs. Those standards not only protect human participants, but they also build credibility into any data that are provided to the FDA, particularly by the tobacco industry.
From page 20...
... 2001. Clearing the smoke: Assessing the science base for tobacco harm reduction.


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