FDA: Protecting America's Health

by Food and Drug Administration (FDA)

Science and sound regulation are inseparable at the Food and Drug Administration. Science is the foundation for daily decisions on a wide range of products that affect human health — from the most common food ingredients, to complex medical and surgical devices, to lifesaving drugs and radiation-emitting consumer and medical products.

The science behind the regulatory decisions also is wide-ranging. It is not just the solitary investigator at the laboratory bench doing original research. And it's not just the physician asking questions about the safety and effectiveness of new drugs. Nor is it just the inspector assessing the safety of imported foods. Science at the FDA is all of that — and much more.

For those who want to know what science at the FDA is all about and want to meet the scientists who work there, they will have an opportunity in late April when agency researchers and reviewers gather at the ninth annual FDA Science Forum.

More than a meeting, the Science Forum is a training ground, a marketplace for the exchange of ideas, and a venue at which collaborative relationships can be created and nurtured.

As a training ground, the forum helps scientists learn new technologies and methods to better assess the safety and effectiveness of medical products. As a marketplace for ideas, it presents different perspectives on important public health issues, particularly as they might affect scientific and regulatory concerns. And as a venue for collaboration, it encourages scientists to work together toward finding better ways to address the nation's emerging health needs.

But the Science Forum is not just for scientists — consumers can benefit too.

"It's a one-stop shop for consumers to meet FDA research and review scientists from across the agency," says Susan Bond, an FDA senior science policy analyst. "It's an opportunity for consumers to voice their concerns, and for the FDA to increase public awareness about its initiatives and activities. This event is the only one of its kind that has this much openness and opportunity for public participation."

This year's forum, scheduled for April 24-25 at the new Convention Center in Washington, D.C., offers a mix of presentations, scientific posters, exhibitions, and breakout sessions — all of which allow consumers and scientists to exchange ideas and insights. Each presentation is followed by a question-and-answer period, during which attendees can ask scientists about their topics. An exhibition hall is the perfect setting for consumers to speak with scientists whose posters depict the FDA's recent scientific achievements. Industry representatives with their displays of products and services also will be on hand. And the final breakout session will feature a discussion by representatives from a consumer group and the media on how they partner with the FDA to better convey health information to the public.

Among those invited to speak at the forum are Health and Human Services Secretary Tommy G. Thompson, Centers for Disease Control and Prevention Director Julie L. Gerberding, M.D., M.P.H., and FDA Commissioner Mark B. McClellan, M.D., Ph.D. Others scheduled to make presentations include experts from the National Institutes of Health, Environmental Protection Agency, and Department of Defense, as well as scientists from major universities and industry labs.

This year's Science Forum program highlights three priority areas in which the FDA is working to protect America's health: risk assessment and management, novel science initiatives, and science in the aftermath of the events of Sept. 11, 2001.

Risk Assessment and Management

Emerging technologies, such as blood substitutes, genetically modified food and transgenics, translate into products with new complexities and uncertain risks. Part of the FDA scientist's job is to judge whether a new product's benefits will outweigh its risks. "Scientists can never get enough information to answer all the questions about a product or a technology," says Norris Alderson, Ph.D., the FDA's senior associate commissioner for science. Scientists must gather as much information as possible, but also must determine when they have enough data to safely assess risk and deem that a product won't cause harm. "It's a continuing balance," adds Alderson.

Get a first-hand look at how FDA scientists screen chemicals for their cancer-causing potential, assess the risk of foodborne bacteria and viruses, and work to minimize the risk of regulated products and technologies at the Science Forum.

Novel Science Initiatives

As technology moves forward at an extraordinary pace, the science gets increasingly more difficult. FDA scientists face new public health threats, such as tougher strains of antibiotic-resistant bacteria, more dangerous foodborne illnesses, and life-threatening biological weapons that may be used to contaminate products regulated by the FDA.

"Staying current with novel science and technology represents a continuing educational challenge for every scientist at the agency," says Alderson. New technologies affect a product's characteristics, chemistry, mode of action, and the way it's manufactured. "When a new technology comes along, the scientists have to get retooled. They must develop and apply new standards and techniques in reviewing the product."

Learn how FDA scientists use the latest technology to detect cancer in early stages, test for antibiotic resistance, investigate food and drug tampering, and more, at the Science Forum.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.