Scientific Standards for Studies on Modified Risk Tobacco Products

Scientific Standards for Studies on Modified Risk Tobacco Products
Institute of Medicine
NAS Press | 2011 | ISBN: 0309223989 9780309223980 | 328 pages | PDF | 3 MB

Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease.

MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

CONTENTS
SUMMARY
The Family Smoking Prevention and Tobacco Control Act
Requirement for Regulations, Guidance, and Consultation with the Institute of Medicine
Committee Approach
Evidence and Studies
Study Design and Decision Making
Governance
Findings and Recommendations
References
1 INTRODUCTION
Tobacco Harm in the United States
Harm Reduction
History of Tobacco Regulation in the United States
FSPTCA Overview
Section 911
Comparison of Regulatory Frameworks
Burden of Proof
Committee Charge and Statement of Task
Committee Process
Overview of the Report
References
2 GOVERNANCE AND CONDUCT OF STUDIES
History of Scientific Research Funded or Conducted by the Tobacco Industry
Relevance of Third-Party Governance
Toward a Tobacco Research Governance Entity
Conclusions
References
3 EVIDENCE BASE AND METHODS FOR STUDYING HEALTH EFFECTS
Product Composition
Biomarkers
Preclinical Studies
Clinical Studies
The Use of Modeling in Estimating Health Effects of MRTPs
References
4 METHODS FOR INVESTIGATING ADDICTIVE POTENTIAL
Evaluation of Reinforcement and Addictive Potential
Evaluation of Public Health Risk Using Randomized Clinical Trial Methods
References
5 METHODS FOR STUDYING RISK PERCEPTION AND RISK COMMUNICATION
Background and Rationale: Importance of Risk Perceptions
Perceptions of Epidemiologic Data for Tobacco Use
Perceptions of Tobacco-Related Risks and Benefits to the Individual
Scientific Standards for Studies on Risk Perception and Risk Communication
References
6 DECISION MAKING AND OVERSIGHT OF MRTP STUDIES: FINDINGS AND RECOMMENDATIONS
Issues with Evidence
Integration of Evidence and Decision Making
Findings and Recommendations
References
Appendixes
A SECTION 911 OF THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
B CHAPTERS 1 AND 2 FROM EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS IN CHRONIC DISEASE
C COMMITTEE BIOGRAPHIES
D MEETING AGENDAS

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