Scientific Assessment Approach
Quality and Integrity
Philip Morris International (PMI) is developing a range of candidate Modified Risk Tobacco products with the objective of offering adult smokers a less harmful alternative to continued cigarette smoking. PMI has a rigorous and extensive program designed to assess the potential of these products to reduce the risk of harm compared to continued cigarette smoking that follows established scientific precedents and the FDA’s Draft Guidance for Modified Risk Tobacco Product Applications (MRTPA). The scientific assessment standards and methods are similar to those used by the pharmaceutical industry, including product design controls, a range of toxicological tests, clinical studies, premarket consumer perception and behavior studies, and planned postmarket assessments. PMI relies on the “totality-of-the-evidence” approach, which means that any conclusions about an investigational product’s potential to reduce the risk of harm compared to continued cigarette smoking must be supported and corroborated by the findings from a range of studies, not just a single laboratory test or a single clinical study. PMI filed a Modified Risk Tobacco Product Application (MRTPA) with FDA for its novel Tobacco Heating System (THS) in December 2016. FDA has not, however, granted a marketing order to PMI for an MRTP or determined the data to be sufficient to prove the product reduces the risk.
PMI’s laboratory studies (e.g., aerosol chemistry and toxicological assessments) are conducted in ISO-accredited facilities and follow OECD Good Laboratory Practice principles. The studies are performed at PMI’s laboratories or by the leading third-party experts. For example, PMI contracted Labstat International, the largest independent third-party tobacco testing company in the world, to complete aerosol chemistry testing for its investigational THS heat-not-burn tobacco products. PMI also takes toxicological assessment beyond standard toxicology using a new area of science known as systems toxicology, which allows the use of non-clinical data to help understand the mechanisms that trigger smoking-related diseases and to help quantify the impact of its products on these mechanisms and thereby model their risk reduction potential compared with cigarettes.
The clinical studies are a cornerstone of PMI’s assessment program. The studies are reported on ClinicalTrials.gov, a website managed by the US National Institutes of Health. These studies are designed and conducted in line with the World Medical Organization’s Declaration of Helsinki and Good Clinical Practice (GCP) as defined by the International Conference on Harmonization (ICH). Each of the clinical studies have been reviewed by an Institutional Review Board and/or an Independent Ethics Committee prior to study start. The studies are conducted by established and qualified Contract Research Organizations (CROs) such as Celerion and Covance. These are the same CROs that provide support to the pharmaceutical, biotechnology, and medical device industries.
PMI publishes the results of its studies in peer-reviewed publications and presents the findings at scientific conferences. Since 2011, PMI has published over 160 peer-reviewed scientific articles and book chapters describing its approaches, methods, and product assessment studies.
To further advance scientific and medical knowledge of investigational reduced risk products and to stimulate independent verification of its scientific data, PMI has a multi-year program to obtain independent verification of its methods, data, and conclusions. The program includes the following components:
- Individual expert reports commissioned to verify specific data sets and conclusions. For example, PMI has commissioned a series of experts to review the data on the absence of combustion in its THS heat-not-burn product. In addition to reviewing all the data, some of the experts suggested additional testing, which was performed according to their recommendations. The summaries of these reports can be accessed here.
- sbvIMPROVER: A crowd-sourcing platform allowing the verification of scientific methods and results through a collaborative approach open to all experts.
- Investigator Initiated Studies Program: Currently in the pilot stage, this program has been developed to promote and support independent studies about products with reduced risk potential that have been developed and commercialized by PMI, and to expand scientific and medical knowledge on heated tobacco and e-vapor products.
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