Margaret Hamburg

Margaret Hamburg is commissioner of the U.S. Food and Drug Administration. Photo by FDA

The U.S. Food and Drug Administration has always protected and promoted public health at its core, but 2014 has been an especially busy year for the agency. In February FDA launched its first-ever youth tobacco campaign, targeting the nearly 3,300 American youths under age 18 every day who smoke their first cigarette. Later in the month the agency proposed changes to its Nutrition Facts label for the first time since its introduction to U.S. consumers in 1993.

FDA Commissioner Margaret Hamburg, now in her fifth year as the agency’s top official, spoke to Public Health Newswire about both initiatives, National Public Health Week, current FDA goals and how the U.S. can become the healthiest nation in one generation.

We are delighted to have FDA’s participation in National Public Health Week. What does this year’s theme, “Public Health: Start Here,” mean to you?

Thank you for asking me to join such an important effort. The Institute of Medicine has defined the mission of public health as “fulfilling society’s interest in assuring the conditions in which people can be healthy.”

But what does that mean for an agency like the FDA? In fact, it is very straightforward: To be healthy, people need access to a safe and nutritious food supply and to innovative, safe and effective medical products.

FDA plays an essential role in facilitating access to such products, and in doing so, we strive to protect and promote health, prevent illness and improve the quality of life. As a science-based regulatory agency with a public health mission all of our activities must be guided by the best possible data and science. We must shape our programs, policies and decision-making on sound evidence, and we must continually reevaluate scientific and regulatory strategies against real-world outcomes.

Today’s National Public Health Week theme of prevention ties into several FDA initiatives, such as your first-ever tobacco youth prevention campaign. What goals have you set for this and other prevention campaigns?

Those of us in the public health and medical communities know all too well the startling statistics surrounding teen tobacco use, especially smoking, and want to do all we can to prevent young people from becoming addicted. Unfortunately there are more than 10 million youths ages 12 to 17 who are open to smoking or already experimenting with cigarettes. In fact every day in the U.S. nearly 3,300 youths under age 18 smoke their first cigarette, and more than 700 become daily cigarette smokers.

Therefore we launched our first national public-education campaign. “The Real Cost” is designed to prevent young people from using tobacco and to reduce the number of kids ages 12-17 who become regular smokers.  The campaign also aims to achieve several public health goals, including educating at-risk youth about the harms of tobacco use, reducing initiation rates among youth who are open to smoking and reducing the number of young people already experimenting with cigarettes who become regular users. This initial FDA effort is the first of five distinct youth-focused campaigns planned in the coming years designed to prevent and reduce youth tobacco use over time.

It’s been more than 20 years since the first Nutrition Facts label, and in February you proposed important changes. How would these changes keep our nation’s food safer and healthier?

The proposed update to the Nutrition Facts label for packaged foods reflects the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving size requirements to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label driving consumers’ attention to calories, servings and Percent Daily Value — three important pieces of information that could assist consumers in making healthier food choices.

APHA is striving to help the United States become the healthiest nation in one generation. What do you see as the most important health issues to address in the coming years and how can public health professionals, including APHA, work with you to make this vision a reality?

We face many important health challenges today. Successfully transforming our country into the healthiest nation in one generation is a worthy goal — but will require a renewed commitment to the importance of prevention as well as achieving major reform in health care.

From the FDA perspective one critical challenge involves how we can help to fully leverage the opportunities in science and technology to develop better, safer and more effective strategies to diagnose, treat, prevent and even cure disease. We also must respond to the rapid globalization of the manufacture and market for medical products and foods, bringing new complexity and vulnerability to the products Americans consume and use. Both of these critical challenges require new partnership across government agencies and levels of government, as well as across disciplines, sectors and borders.

Without a doubt APHA can bring important expertise, advocacy and leadership to these efforts and we are eager to work with you to achieve our common goals for health.

You have been a champion in advancing regulatory science. How can the academic community assist FDA with this important task?

Rapid advances in science and technology offer extraordinary new opportunities to improve health and prevent and/or treat disease and are bringing fundamental changes to the products we regulate at FDA — both in the nature of the products themselves and how they are developed, evaluated, manufactured and used. Our ability to deliver on the promise and demand of science today depends in vital ways on a modern and robust field of regulatory science. Supporting the more efficient, streamlined development of products and the tools, standards and approaches for assessment — of their efficacy, safety, quality and regulatory science — in fact represents the critical bridge between exciting scientific discoveries and new, marketed products.

In my view advancing regulatory science is a vital and urgent challenge for the brightest minds in academia, industry and government. We must work together to define and implement an essential regulatory science research agenda.

There are many promising models for collaboration. FDA’s innovation initiatives emphasize that bringing regulatory science into the 21st century requires the collaborative efforts of all stakeholders, including academia. One such example is FDA’s Centers of Excellence in Regulatory Science and Innovation, or CERSI. Currently a few schools have such centers which allow for a joint effort between academia — in this case universities — and the FDA to work collaboratively on projects that promote regulatory science including innovative research, education and scientific exchange.

 

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