Acting under the Tobacco Control Act’s mandate and its engagement by the FDA Center for Tobacco Products, the Institute of Medicine (“IOM”) recently released its recommended minimum standards for the regulation of modified risk tobacco products (“MRTPs”). The 12 recommendations, contained within the IOM’s December 14, 2011 report, Scientific Standards for Studies on Modified Risk Tobacco Products (the “Report”), highlight the IOM’s task to address “premarket and post market studies in support of MRTPs,” with an emphasis on the “types and characteristics” of evidence that the FDA will need to evaluate an MRTP application before such products are approved to enter the marketplace. For example, the IOM recommends the FDA to require studies submitted in support of an MRTP application to address “all key research domains” necessary to “forecast and monitor the product’s public health impact” (e.g. the MRTP’s composition and potential for addiction). Notably, and as the Report makes clear, the IOM was not tasked with addressing post-market surveillance activities for MRTPs even though the Tobacco Control Act requires the FDA to issue such regulations based on the IOM’s input.
Importantly, the IOM determined that its obligation under the Tobacco Control Act to provide recommendations on the design and conduct of MRTP studies and surveillance authorized the IOM to address “not only issues concerning research methods and scientific standards, but also issues concerning research conduct and governance.” As such, the Report sets forth three recommendations specifically related to the governance of MRTP studies, which include:
- The use of FDA-approved independent third parties to design and conduct the MRTP research and distribute sponsor funds for research;
- Public disclosure of all data generated in the development and marketing of MRTPs; and
- Established standards and principles of research governance (e.g. qualified investigators, transparency, independent institutional review boards or ethical review).
These governance recommendations for MRTP studies were proposed to combat public perception of prior tobacco-related or tobacco-funded research that the IOM characterizes as “distrustful.” Even in light of this public sentiment, which the IOM acknowledges has resulted in university bans on tobacco research, the IOM hopes that these governance mechanisms will facilitate beneficial relationships between MRTP applicants/sponsors and independent researchers.
A summary and an electronic copy of the IOM’s full Report is available online at http://www.nap.edu/catalog.php?record_id=13294#aboutprepub. The Troutman Sanders Tobacco practice will continue to monitor developments in the regulation of MRTPs.
Contributor: Craig Elkins
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco practice partner, at 804.697.1420 or by email.