LAUSANNE, Switzerland -Monday, January 29th 2018 [ AETOS Wire ]
First-ever consideration of a heated tobacco product, IQOS, by FDA Advisory Committee
Committee, FDA, and PMI experts discuss comprehensive scientific approach and data set
FDA’s careful review of PMI’s Modified Risk Tobacco Product applications for IQOS continues
(BUSINESS WIRE)-- On January 24 and 25, experts from Philip Morris International Inc. (PMI) and Philip Morris USA Inc. presented to the Tobacco Products Scientific Advisory Committee (TPSAC) before the US Food and Drug Administration (FDA).
The meeting was part of the FDA’s review of PMI’s request to commercialize IQOS in the US as a “Modified Risk Tobacco Product”. U.S. law and policy recognize product innovation as important to the 40 million American men and women who smoke.
To advise the Agency on PMI’s applications, the Committee covered a wide range of scientific, technical, and consumer-communications topics. It raised questions and probed the likelihood and magnitude of potential benefits as well as how best to address possible unintended use.
Although the Committee did not agree with some of the specific language of proposed risk and harm consumer communications, it confirmed that the evidence supported the statement that switching completely to IQOS significantly reduces exposure to harmful chemicals.
“The Committee’s two-day discussion was a milestone event. We thank the Agency and the Committee for their interest in our scientific dossier and our determination to enable adults who smoke to have access to and information about better alternatives,” said André Calantzopoulos, PMI’s Chief Executive Officer, who added: “I am deeply grateful to my colleagues for their exceptional work on our application to the FDA and for the presentations last week. Our science and the commitment of our people give me confidence that we will realize our vision of a smoke-free future.”
We believe the Committee’s interactions with presenters and its discussion reflected respect for our scientific data and commitment to bring IQOS to the U.S. The Committee delved into such areas as inferences about long-term health outcomes, quantification and comparison of risk, the best way to formulate consumer information, and areas for post-market surveillance. At the end of the meeting, the Members of the Committee discussed and voted on particular questions on which the Agency requested the Committee’s views. TPSAC recommendations and votes are not binding on the FDA.
“As a next step, we look forward to working with the Agency to clarify outstanding points so as to best assist in their ongoing decision-making process, which inherently entails a certain degree of scientific uncertainty pre-market,” said Mr. Calantzopoulos, who concluded: “As the FDA routinely does with regard to the many products it regulates, I believe the Agency will ultimately address that uncertainty in the best interest of people who smoke.”
Since 2008, PMI has invested more than USD 3 billion in scientific research, product and commercial development, and production capacity related to IQOS and other smoke-free products. In 2017, over 70% of global R&D expenditure and over 30% of global commercial expenditure was allocated to smoke-free products, and we plan to invest more than USD 1.7 billion in facilities to manufacture them.
Nearly 4 million adult smokers have already switched to IQOS. Our ambition is that all those who would otherwise continue smoking abandon cigarettes and switch completely to scientifically substantiated smoke-free products as soon as possible. Regulatory policies and decisions can substantially accelerate the speed and magnitude of this historic change.
Note to the editor
The FDA is reviewing PMI’s MRTP applications pursuant to the provisions of a 2009 Statute that granted the Agency authority with respect to tobacco products. Under the Statute, the FDA’s decision takes account of scientific evidence as well as comments, data, and information submitted by interested persons.
As previously announced, in 2018 PMI will complete a 12-month exposure response study designed to measure clinical risk markers in adult smokers who switch to IQOS.
PMI has also submitted a Pre-Market Tobacco Application (PMTA) to the FDA which, if granted, will permit the commercialization of IQOS in the US without modified risk messages. This application was not before the Committee as it follows a separate regulatory pathway.
Under agreements with PMI, PM USA is licensed to sell IQOS in the U.S. should PMI receive a PMTA marketing order from the FDA.
Philip Morris International: Who We Are
We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We’re building our future on smoke-free products that are a much better choice than continuing to smoke cigarettes. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirements. Our vision is that these products ultimately replace cigarettes to the benefit of adult smokers, society, our company and our shareholders. For more information, see our PMI and PMIScience websites.
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