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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks to the Tobacco Products Scientific Advisory Committee

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
to the
Tobacco Products Scientific Advisory Committee
March 30, 2010

Good morning. I’m very pleased to be here this morning and want to thank you for your willingness to serve on this scientific advisory committee. I hope that you are ready and eager to dive into this enormous task—this great public health challenge—that we have been charged with tackling. There is a lot of work to do—we can all agree on that. Dr. Samet mentioned the giants on whose shoulders we all stand…In fact, as I think about what lies ahead, I am reminded of the legendary story of Dr. John Snow.

Now, those of you who—like me—come from a public health background probably know this story quite well already. But whether you’ve heard it before or not, Dr. Snow’s is an example we should bear in mind as we make decisions that will affect the lives of so many Americans.

Dr. Snow was a physician practicing in London during the middle part of the 19th century—a time when the city was facing a series of severe cholera epidemics.
Most doctors then believed that cholera was caused by what people called bad air or “miasma” — but Dr. Snow had his own theory. He suspected the disease had one common origin. So he painstakingly plotted each known cholera case on a map of the city.

Sure enough, every case could be traced back to a single water pump. Dr. Snow was right.

The solution to what seemed like a complicated and dangerous epidemic was now simple. Snow recommended that they take the handle off the pump. And once they did, the cholera rate immediately began to decline. It was a brilliant public health move…and it marked a new era in public health. It was a clear and compelling example of bringing science to bear on an important public health problem. An example of how informed action can make a difference to the health and well-being of populations, and can bring true scientific understanding to a set of issues that can become very emotionally charged.

I mention this because I think that we too are on the cusp of a new era in public health…and you – the members of this committee – have the chance to make history. You have the chance to provide your scientific input and expertise as we address one of the most pressing public health problems of our day. You have the chance to weigh in on implementing the Tobacco Control Act. You have the chance to help us at the FDA take the handle off the proverbial pump.

So that, together, we can fight lung cancer, coronary heart disease, stroke, emphysema — and the staggering half-million or so deaths caused by tobacco every year.

This Committee isn’t charged with interpreting the Tobacco Control Act or helping draft regulations — believe me, we have an incredible team of attorneys and regulatory experts to help us with that. Instead, your role is unique and, really, much more important. It is up to you to provide us with the scientific foundation that will guide FDA in crafting those regulations—which includes examining the effects of altering nicotine yields from tobacco products and determining whether there are threshold levels below which nicotine yields don’t produce dependence.

That, after all, is this Committee’s overarching mission: to provide the advice, information, and recommendations necessary to effectively regulate tobacco products. Today, you are jumping right into the science with this meeting’s focus on menthol in cigarettes.
But your work doesn’t end here. In the months and years to come you will be tasked with exploring other safety, dependence, or health issues as they emerge.
I’m sure you’ve heard this more than once — and I’m quite certain you’ll be hearing it again — but FDA regulation of tobacco products is a science-based, science-driven process…it must be. And you are the women and men mandated to provide us with the best available science.

So, on behalf of all of us at FDA, I’d like to extend our appreciation to you for your commitment and for your service. I’d like to especially thank Dr. Samet, for taking on the important role of the Chair and also thank Dr. Deyton and his amazing team who have done so much to implement this new tobacco legislation and to organize this first meeting of the Scientific Advisory Committee. And to issue a simple challenge: ladies and gentlemen, follow the science wherever it leads you. Only then, can we take the handle off the pump once and for all.

Thank you.