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U.S. Department of Health and Human Services

Advisory Committees

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Remarks by Joshua M. Sharfstein, M.D, Principal Deputy Commissioner of Food and Drugs, at the Tobacco Products Scientific Advisory Committee Meeting on July 16, 2010

Thank you for a few moments of your time this morning. I asked for this chance to come speak with you to express the appreciation of FDA for the remarkable commitment and expertise you have brought to this scientific advisory committee.
Prior to coming to FDA, I served as the city health commissioner of Baltimore City. Before that I served on the staff of Congressman Henry Waxman. And I am trained and have worked as a pediatrician.
So as you might imagine, I had at least three good reasons to celebrate the passage of the Family Smoking Prevention and Tobacco Control Act last year.
This law is intended to improve health in the United States – by protecting children from addiction and disease, helping tobacco users quit, and reducing the enormous toll of suffering and death from tobacco products in this country.
To succeed, FDA needs good advice.
I want to take this opportunity to describe publicly how FDA assembled such a terrific group to help us as we launch tobacco regulation in the United States – and how we address issues related to conflict of interest and bias.
Last fall, FDA received more than 100 nominations for voting members of this committee. We then asked the Assistant Secretary for Health, Dr. Howard Koh, to bring together public health leaders from the National Institutes of Health, Centers for Disease Control and Prevention and the Federal Trade Commission. We gave this group the requirements of the Tobacco Control Act and a big pile of CVs. They then worked to identify top experts to advise our new program.
Experts like Dr. Jonathan Samet, a member of the Institute of Medicine who was twice awarded the Surgeon General’s Medallion for his work as editor for Reports of the Surgeon General on tobacco.
Experts like Dr. Dorothy Hatsukami, a Professor of Cancer Prevention at the University of Minnesota who edited the chapter on nicotine addiction in the Surgeon General’s Report on how tobacco causes disease.
Experts like Dr. Neal Benowitz, the Chief of Clinical Pharmacology at the UCSF School of Medicine, a past president of the Society for Research on Nicotine and Tobacco, and one of the scientific editors of the National Cancer Institute monograph on the health risks of low tar cigarettes.
Experts like Dr. Melanie Wakefield, a leader in mass media, advertising, marketing, brand images and warning labels, and behavioral research.  She has served as the senior editor to the National Cancer Institute monograph on the role of the media in promoting and reducing tobacco use.
And experts like Dr. Jack Henningfield, a global leader in addiction research who has advised HHS, the World Health Organization, and the International Agency for Research on Cancer. He served as scientific editor of the Report of the Surgeon General on the Health Consequences of Smoking: Nicotine Addiction.
I could go on and mention every one of you. But let me just say that we are honored to have such leading experts serve as advisers, and we deeply appreciate your counsel and perspective.
Dr. Koh and his team did a terrific job identifying top experts. But that was just step one. We next evaluated conflict of interest before making any final selections.
This is an obligation the agency takes very seriously for all of our external advisory committees – both in assembling the committee, and before each and every meeting.
Our approach to the tobacco committee started with the fact that no voting member on this committee is permitted to have a financial interest in the tobacco industry during their service on the committee or for the 18 months prior to their appointment. This not only makes sense … it is specified in the law.
In addition, before each meeting, we determine the agenda and then compile a list of products and firms that could be affected by the discussion and outcomes of the meeting and any FDA decision based on the committee’s recommendations. This list could include tobacco products, laboratory tests, or even drugs and devices if these will be discussed or implicated. We send you this list along with a confidential financial disclosure form and instructions for completing the form. Voting members then complete this form, identifying all financial interests that they have in the products or firms. 
These financial interests include all stocks and investments, consulting relationships, research support and grants, employment, patents, work as an expert witness (including the specific topics of testimony), and other activities. We count imputed interests, such as grants to the institution and the interests of a spouse or minor child.
This confidential information is then reviewed by staff from various offices in accordance with FDA’s procedures: the Center for Tobacco Products, FDA’s Advisory Committee Oversight and Management Staff, FDA’s Ethics and Integrity Staff, and, as necessary, the Office of General Counsel/Ethics Division of the Department of Health and Human Services.
Based on these reviews, we consider whether the meeting will have a direct and predictable effect on these financial interests. If there is a disqualifying financial interest, we will generally ask that you recuse yourselves from the meeting. If there is a disqualifying conflict of interest, you do not participate unless granted a waiver. A waiver can only be granted under limited circumstances and would be made public. We have not granted any waivers for TPSAC meetings to date.
According to our law and regulations, when specific products come under discussion, we consider appearances that may arise from personal and business relationships in accord with the standards of ethical conduct for all government employees. With the guidance of ethics staff, we then determine whether an appearance concern outweighs the value of your contribution to a particular meeting.   When such issues arise, we may ask additional questions of you or ask you to step back from meetings.
In addition to taking steps to address conflict of interest, FDA regulations permit the agency to remove a member from an advisory committee who demonstrates bias that interferes with the ability to provide us with objective advice.
In applying this rule, we understand that a stated opinion on a scientific matter does not necessarily mean that a member would have a closed mind on a particular issue. After all, by definition, experts have views about issues that fall within their particular areas of expertise. 
I know that this whole process can be burdensome on you. But I also know why this process exists. It exists to ensure that the integrity of the expert advice FDA receives on tobacco and all other issues handled by the agency.
It is a process supported by the Department of Health and Human Services and recently affirmed by the Office of Inspector General.
It is also a process that FDA stands behind.
When questions are raised from any quarter, we review them. We take them seriously. We are prepared to take appropriate action when we find the concerns have merit … and we are prepared to hold steady when we find the concerns are not justified.  
Identifying top experts … applying our laws and regulations fairly … This is how we benefit from your expertise to develop an effective public health program on tobacco.
Good luck today, and thank you.