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By Michelle Meadows
You don't have to know the difference between a virus and a bacterium to benefit from the Food and Drug Administration's 2005 Science Forum, an annual event aimed at sharing the science behind the agency's regulatory decisions.
This year's forum is scheduled for April 27‚28, 2005, at the Washington, D.C., Convention Center. A free public session targeted to consumers is set for April 26. FDA experts and other health professionals will conduct the "plain English" session.
With the theme "Advancing Public Health Through Innovative Science," this year's science forum will showcase the FDA's scientific achievements, encourage discussions on FDA topics, promote collaboration, and recognize outstanding research.
Lawrence X. Yu, Ph.D., chairman of the 2005 FDA Science Forum organizing committee, says, "'Advancing' reflects the FDA's mission to protect and advance the public health and 'Innovative' reflects the FDA's good manufacturing practices and critical path initiatives." The FDA's critical path initiative centers on spurring the development of new medical products.
Sessions at the science forum will cover a range of topics, from emerging technologies for cancer diagnosis and treatment to advances in fighting contagious diseases and bioterrorism. Along with giving presentations, experts will also exhibit scientific posters.
Yu says this year's forum has several new features, including a session called "Meet the Center Directors" and interactive roundtable discussions with FDA leaders on clinical trials, immunology, toxicology, and other timely topics.
The FDA remains committed to increasing consumer understanding of FDA issues. This is the second year that the science forum will offer a free public session. Titled "Personalizing Your Healthcare: The Best Consumer Is an Educated Consumer," the program will give consumers an opportunity to learn about personalized medicine, generic drugs, and nutrition. Janet Woodcock, M.D., acting deputy commissioner for operations at the FDA, will lead the session, scheduled for 1 p.m. to 5 p.m. on April 26.
Personalized medicine: Felix Frueh, Ph.D., a scientist with the FDA's Center for Drug Evaluation and Research, and Finley Austin, an expert at the Personalized Medicine Coalition in Washington, D.C., will discuss the growing role of personalized medicine in health care.
"We know that genetic variations can affect how individuals respond to disease and to drugs," Frueh says. Personalized medicine involves getting the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood proteins or cell surface proteins.
For example, personalized medicine could include the use of a genetic test that can assess the likelihood that someone with breast cancer will have a recurrence. Another example is using genetic information to help health professionals select a type of medication or the dose.
Frueh cites the drug Tarceva (erlotinib) as a recent example of a drug with a label that shows how people who seem the same can respond differently to treatments. The FDA approved Tarceva in November 2004 for certain people with lung cancer. Tarceva was developed to block an important signal that stimulates the growth of cancer cells.
Frueh says, "From a regulatory perspective, we want to package information about genetics in a way that is understandable for patients and physicians. A drug label needs to be scientifically sound, but it also needs to be possible for people without formal training in genetics to understand this additional information and its implications."
Generic drugs: Jack Billi, M.D., associate vice president at the University of Michigan, and Gary Buehler, R.Ph., director of the FDA's Office of Generic Drugs, will give presentations in a session titled, "Generic Drugs: Are They Really As Good?"
"Consumer confidence in generics is increasing," Buehler says. "More products are becoming available in generic form and consumers have grown to trust their quality." This session will provide an understanding of the FDA's review and approval process for generic drugs.
"We learn very early that cost usually goes hand in hand with quality," Buehler says. "But for generic drugs, the cost differential is linked to the requirements for approval, not quality or ingredients. Because manufacturers of generics don't have to perform the expensive efficacy and safety testing, generics can be made and sold less expensively. The FDA assures that the products are manufactured to meet the same rigid standards as the brand products, and that the generics are shown to be equivalent to the brand products in safety and efficacy."
The FDA is partnering with many pharmacies and insurance companies to get the message out that generics are less expensive than brand-name products, and they are also as safe and effective. "This is especially important because we know that many consumers have difficulty affording many of the prescription drugs they need," Buehler says.
Dietary guidelines and nutrition: A session focusing on the connection between food and health is titled, "Are You What You Eat? A Critical Look at the New Dietary Guidelines for Americans, the Science of Nutrition, and Personal Choices for a Healthier Life."
Barbara O. Schneeman, Ph.D., director of the Office of Nutritional Products, Labeling, and Dietary Supplements, part of the FDA's Center for Food Safety and Applied Nutrition, is one of the presenters. "The session will discuss the dietary and lifestyle factors that are associated with improving health and reducing the risk of chronic disease," Schneeman says. Janet King, Ph.D., chairwoman of the Dietary Guidelines Advisory Committee, also will make a presentation.
Dietary guidelines are updated and released every five years and contain the latest nutritional and dietary guidance for the general public. For example, the guidance stresses the health benefits of a diet that's low in saturated fat and cholesterol and high in fruits and vegetables.
Schneeman says, "We want to help consumers understand the connection between scientific evidence and recommendations that the government will use to support its education and public health programs." The dietary guidelines establish the direction for government nutrition programs, including research, education, labeling, and nutrition promotion.
Registration for the free public session and the regular forum is required. More Information.
On April 28, participants of the 2005 FDA Science Forum will hear from the following directors of the Food and Drug Administration's product review and research centers on what issues they think will be of critical importance during the year.