PMI Presents to US FDA Advisory Committee; Important Milestone in the Scientific Review of IQOS
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.
Philip Morris International media office
T: +41 (0)58 242 4500
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
2018 Healthcare+ Expo Taiwan: Where Tech Meets Medicine15.8.2018 13:03 | Pressemelding
From November 29th to December 2nd 2018, global-leading biomedical and technology institutes will gather in Taipei for the top healthcare and technology event in Asia - The Healthcare+ Expo - Taiwan. In line with the theme “Med X Tech”, a lineup of global leaders in technology will share the latest technology advancements and how technology create better solutions for future medical applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005001/en/ This year, the expo gathers 400 + world-class medical institutes and multi-national IT/ICT/electronic giants. The IT giants will showcase medical innovations of AI, IoT and robotic technologies. The medical institutes will demonstrate advanced medical technologies, smart hospital designs, products, and services while bio-pharmaceutical, medical device, and genetic enterprises will provide the most current updates in precision medicine. In all, more than 1,400 booths wil
QConnect - The Most Intelligent, Global, Ultra-Compact, Rugged Communication Device15.8.2018 13:00 | Pressemelding
Quake Global, Inc. (QUAKE), a leading provider of solutions to the global IoT market, announced the launch of their advanced telematics device, QConnect™. The Ultra-compact QConnect integrates with fixed and mobile assets for real-time tracking, monitoring and control anywhere, anytime. The device provides a variety of advanced, wireless communication options, including LTE/2G/3G, dual-band Wi-Fi, Bluetooth/BLE, V2X, and satellite. The device is designed to meet the demands of a wide variety of requirements from simple low-cost tracking applications to high-performance, multi-channel, video streaming applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005104/en/ Quake Global’s new QConnect, the most intelligent, global, ultra-compact and rugged communication device available (Photo: Business Wire) QConnect is flexible with unique apps and software options on an open source Linux platform. Control your vision w
PEI-Genesis Names Kris Haggstrom Senior Director of E-Commerce and EMS15.8.2018 11:07 | Pressemelding
PEI-Genesis, a global leader in the design and assembly of custom engineered connectors and cable solutions, has named Kris Haggstrom Senior Director of E-Commerce and Electronic Manufacturing Services (EMS), it was announced today by Peter Austin, Corporate Vice President, PEI-Genesis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005021/en/ PEI-Genesis names Kris Haggstrom Senior Director of E-Commerce and Electronic Manufacturing Services (EMS). (Photo: Business Wire) “As PEI-Genesis has grown into a stronger, larger, global company capable of providing services across all markets, our customers have always considered us to be their connector solutions provider,” said Austin. “We have moved from being known as the fastest custom assembler of connectors, to having the largest available-to-sell connector inventory, to making finished cable assemblies, to providing total custom engineering and design capabilities. Wit
Quanergy Signs Oprema as Distribution Partner for UK and Ireland15.8.2018 10:00 | Pressemelding
Quanergy Systems, Inc., a global leader in the design and development of solid state LiDAR sensors and smart sensing solutions, today announced a partnership with Oprema, the fastest growing U.K. security distributor. Through the partnership, Oprema will provide full distribution support for Quanergy’s QORTEX™ for Security system across the United Kingdom and Ireland. Oprema will be Quanergy’s first distributor in the U.K. and Ireland, and will provide access to Quanergy’s LiDAR-based security system QORTEX for Security, an intelligent 3D perimeter fencing system that combines LiDAR hardware and software to enable real-time 3D detection, tracking and classification of security breaches. The solution was developed for use across various industries in which large-scale perimeter monitoring is essential. Tim Duggan, technical director at Oprema commented: “We are delighted to have signed a distribution agreement with Quanergy and are extremely excited about the technological advancements
itslearning and Google for Education Strike New Education Partnership, Deliver Major New Integrations to Improve Learning Outcomes15.8.2018 06:00 | Pressemelding
itslearning today announced its collaboration with Google for Education, delivering the first phase of a comprehensive technology roadmap. This initial milestone aligns with the itslearning mission to improve the efficacy of technology in education. The collaboration will involve significant work across R&D, Sales, and Marketing functions. With phase one complete, these capabilities are now available: Use of Google assignment templates to quickly ‘make a copy’ of a single Google file for each student with one click Easy administration of assignments within the itslearning environment by uploading from or linking to documents on Google Drive Ability to collaborate and give real-time feedback in Google Docs directly from an itslearning assignment screen Automatic management of file permissions to prevent learners from making post-deadline changes to a submitted file View, annotate, and grade submitted files with a grade or against a rubric, all from within one itslearning screen “We are
Pacific Drilling Announces Second-Quarter 2018 Results14.8.2018 21:38 | Pressemelding
Pacific Drilling S.A. (OTC: PACDQ) today reported results for the second quarter of 2018. Net loss for the second-quarter 2018 was $103.7 million or $4.86 per diluted share, compared to net loss of $96.1 million or $4.50 per diluted share for the first-quarter 2018, and net loss of $138.1 million or $6.48 per diluted share for second-quarter 2017. Pacific Drilling CEO Paul Reese commented, “This quarter we continued to provide outstanding operational services to our clients, delivering revenue efficiency of 98.7 percent. Our strong operating results have been recognized by clients as we successfully secure new work for our high-specification, deepwater drillship fleet. Petronas recently exercised its option to contract Pacific Santa Ana for an additional year of work commencing in mid-2019. In addition, we have a letter of intent from Eni for Pacific Bora to work in Nigeria, as well as two letters of award for drilling services in the U.S. Gulf of Mexico for Pacific Khamsin and Pacific