Overview
On July 7, the FDA Center for Tobacco Products (CTP) issued its second round of MRTP marketing orders. CTP is currently reviewing applications for several additional types of products, and manufacturers have announced that more applications are on the way. In this session, panelists will discuss the MRTP process in detail, including what factors to consider when deciding whether to file an application and what happens after a marketing order is issued. Panelists will then address whether the MRTP process is an effective tool for facilitating smoking cessation and promoting public health.
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Speakers
Joe Ackerman, Vice President for Marketing-Smokeless, Swedish Match US
Clive Bates, Director, Counterfactual Consulting Limited
Mohamadi Sarkar, Fellow, Scientific Strategy and Advocacy, Altria Client Services
Moderated by Barry S. Schaevitz, Partner, Fox Rothschild LLP
CLIVE BATES is the Director of Counterfactual Consulting Limited. Mr. Bates has had a diverse career in the public, private, and not-for-profit sectors. He started out in IT marketing for IBM then switched careers to work in the environment movement, including for Greenpeace. From 1997-2003 he was Director of Action on Smoking and Health (UK), campaigning to reduce the harms caused by tobacco. In 2003, he joined Prime Minister Blair’s Strategy Unit as a civil I servant and worked in senior roles in the public sector in the UK and for the United Nations in Sudan. At the start of 2013, he opened a new venture, Counterfactual, a consulting and advocacy practice focused on a pragmatic approach to sustainable development, energy policy, and public health.
MOHAMADI SARKAR is a Fellow, Scientific Strategy, in Regulatory Affairs at Altria Client Services (ALCS) in Richmond, VA. In this role, he provides strategic direction towards developing the science and evidence for regulatory submissions for non-combustible tobacco products with a focus on the regulatory requirements for potentially reduced harm tobacco products. Before being appointed to his current position, Dr. Sarkar lead Clinical Research at ALCS. In that role, he enabled responsible product development and tobacco-harm reduction by generating evidence form clinical studies related to products made by Altria Group’s tobacco companies. He has authored more than 100 scientific peer-reviewed publications and presentations at scientific meetings. Dr. Sarkar has also participated in multiple seminar presentations and authored a variety of scientific book chapters related to his areas of expertise. Before joining the Altria family of companies, Dr. Sarkar served as Associate Professor, Clinical Pharmacology for the Medical College of Virginia (MCV) at Virginia Commonwealth University in Richmond from 1998-2002. He is still affiliated with the university and continues to teach clinical pharmacology. From 1990 to 1998, Dr. Sarkar worked at West Virginia University in Morgantown, W.Va., where he held a variety of positions including: Associate Professor, Clinical Pharmacology; Associate Professor, Genetics, and Developmental Biology; and Associate Professor, Tobacco Research Center, WVU Cancer Center.
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