A Rough Road Ahead for Modified Risk Tobacco Products

  • January 9, 2012

By Marla Scarola

In the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA was given the authority to oversee the process of approving modified risk tobacco products (MRTP). The law also directed the FDA, in consultation with the Institute of Medicine (IOM), to develop guidance on what types of studies would be needed to support the approval of an MRTP. Recently IOM issued a draft report to the FDA outlining the scientific standards for studies on MRTPs.

It is clear from the draft report that IOM believes that new clinical studies need to be conducted on any tobacco products that are believed to be of reduced harm when compared to cigarettes. Although there is a significant amount of literature available on many products, such as smokeless tobacco and Swedish snus, there is concern that these data and publications may be biased. IOM discusses the dishonest tactics employed by the tobacco industry in the past and, based on this, concludes that the FDA cannot trust new data that the industry generates. Rather, there is substantial discussion of the need for a third party governance entity to conduct clinical studies of MRTPs. The establishment of a third party governance entity will take time and money and a funding source is not clearly defined. Any funding provided by the tobacco industry will need to be carefully distributed in a way that prevents questions of impropriety from being raised.

According to the American Cancer Society, smoking is the most preventable cause of death in our society with tobacco use being responsible for nearly 1 in 5 deaths in the United States. It is a primary goal of the public health community to decrease the number of smokers. There are currently products on the market that have been shown in the published literature to impart less harm than cigarettes and many more products are in development. If adopted, the report from the IOM will make it almost impossible for any tobacco companies to introduce reduced harm products on to the U.S. market in the near future. It is hard to understand how prolonging the amount of time that will pass before MRTPs can be marketed to consumers as safer alternatives to cigarettes is in the best interest of the public health. For those current smokers who are willing but unable to quit, making less harmful products available as soon as possible should be the top priority.

The FDA is due to release its guidance on approval requirements for MRTPs in April 2012. The stance that is taken on the need for a third party governance entity to oversee and generate clinical data will say a lot about the FDA’s view of MRTPs and whether they are willing to work collaboratively with the tobacco industry for the benefit of the public health.

Marla Scarola is a Senior Consultant at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.