ROCKVILLE, Md. -- The U.S. Food & Drug Administration (FDA) is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine's (IOM) recommendation regarding the possible role of third-party governance of industry-sponsored tobacco product research.
The purpose of the docket is to provide an opportunity for all interested parties to comment on, among other things, potential models of third-party governance, including whether there are existing models that may be applicable and the types and aspects of industry-sponsored tobacco product research that could be subject to such governance.
The FDA's Center for Tobacco Product (CTP) recently hosted a public workshop focused on the topic.
Contributors must submit electronic or written comments by Sept. 30, 2013, on Docket No. FDA-2013-N-0305 online at www.regulations.gov or via mail to the FDA in Rockville, Md.
On June 22, 2009, President Obama signed into law the Family Smoking Prevention & Tobacco Control Act, which amends the Federal Food, Drug & Cosmetic (FD&C) Act and grants FDA authority to regulate the manufacture, marketing and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors.
The FDA expects that tobacco product manufacturers will undertake tobacco product research as part of activities regulated under the Tobacco Control Act, including submission of applications for marketing orders. The FD&C Act requires FDA to issue regulations or guidance on the scientific evidence required for assessment and ongoing review of modified risk tobacco products (MRTPs). It requires that such regulations or guidance be developed in consultation with the IOM, among others, on the design and conduct of such studies and surveillance.
Pursuant to this requirement, the IOM convened a multidisciplinary committee and published a report in December 2011. In the report, Scientific Standards for Studies on Modified Risk Tobacco Products, the IOM notes that "governance of research is critical to the production of credible and reliable evidence."
"There is profound distrust of the tobacco industry and of research supported by the tobacco industry. This distrust is the direct result of the tobacco industry's history of improperly influencing or manipulating scientific findings and messaging about the health effects of tobacco. This history and the lack of trust may prevent independent experts from participating in research on tobacco products and therefore may impede the production of data on MRTPs necessary to assess public health impact," the report said.
The IOM also notes that "the tobacco industry currently lacks the infrastructure and expertise to independently produce the necessary evidence to support an application to market an MRTP."
As a result of these findings, the IOM recommends in its report that "MRTP sponsors should consider use of independent third parties to undertake one or more key functions, including the design and conduct of research, the oversight of specific studies, and the distribution of sponsor funds for research. Such independent third parties should be approved by the FDA in advance of the research."
The IOM report focuses on research to support MRTP applications, but FDA is also interested in information on third-party governance as it relates more generally to industry-sponsored tobacco research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industry-sponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products.
As FDA considers how and whether to implement third-party governance of industry-sponsored tobacco product research, it is requesting comments on the IOM's recommendation regarding:
1. What are some potential models of third-party governance of industry-sponsored tobacco product research? What are the strengths and weaknesses of these models?
What criteria could FDA use to evaluate any potential model of third-party governance of industry-sponsored tobacco product research?
What role would various interested parties (e.g., individual researchers, academic institutions, for-profit and not-for-profit research organizations) play in a third-party governance model of tobacco product research?
Who would participate in a third-party governance model? How could a governance model be structured to reduce conflict of interest and bias in industry-sponsored tobacco product research?
What barriers, if any, would have to be overcome to encourage the broader scientific community to participate in a third-party governance model?
Are there unique research challenges faced by small manufacturers and how should they be addressed in a third-party governance model?
What kinds of tobacco product research could be subject to third-party governance? For example, could it be applied to product testing, nonclinical studies, studies in human subjects (e.g., health effects research, behavioral research, abuse liability studies, consumer perception research), computational modeling or postmarket surveillance?
What aspects of tobacco product research could be subject to third-party governance? For example, should both the design and conduct of research studies be subject to third-party governance?
Are there governance models or other steps that the FDA can take that are more effective for overseeing research to produce generalizable knowledge, such as establishing better testing/research methods and standards, compared to specific product research?
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