PMI: review continuing

Philip Morris International has made the point that the ‘careful review’ by the US Food and Drug Administration of the Modified Risk Tobacco Product (MRTP) applications for PMI’s heated tobacco device IQOS is continuing.
On January 24 and 25, the Tobacco Products Scientific Advisory Committee (TPSAC) carried out, at the request of the FDA, an investigation into the scientific issues related to these MRTP applications and broadly recommended that they be rejected.
On a note posted on its website yesterday, PMI said that experts from PMI and Philip Morris USA Inc. had presented to the TPSAC meeting.
‘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”,’ the note said. ‘US 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.’
Meanwhile, PMI’s CEO, André Calantzopoulos (pictured), described the committee’s two-day discussion as 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,” he was quoted as saying. “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.”
The PMI note said that the company believed the committee’s interactions with presenters and its discussion reflected respect for PMI’s scientific data and commitment to bring IQOS to the US.
‘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,’ the note said. ‘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.’
Calantzopoulos said that as a next step, PMI looked forward to working with the FDA to clarify outstanding points so as to best assist in the agency’s ongoing decision-making process, which inherently entailed a certain degree of scientific uncertainty pre-market. “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,” he said.
PMI has submitted also 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 because it follows a separate regulatory pathway.
Under agreements with PMI, PM USA is licensed to sell IQOS in the US should PMI receive a PMTA marketing order from the FDA