By Kim Coghill

Washington Editor

WASHINGTON - The FDA is one of the oldest consumer protection agencies within the government, and to that end, the agency is the first to open its doors to two-way communication with the public, said Jane Henney, FDA commissioner.

Henney spoke last week at the agency's Consumer Roundtable on Consumer Protection Priorities, an event attended by health-care professionals from across the nation. She cited FDA surveys indicating that 75 percent to 80 percent of respondents have confidence in the agency and believe it makes decisions based on needs of consumers, and plays an active role in protecting consumers. "But we need to be better in helping people get information," she said.

As part of its outreach efforts, the FDA maintains Internet sites where consumers can research information and communicate with the agency through e-mail. Not only have the Internet and other new technologies shaped the future of the FDA and the development of drugs, but within the Center for Biologics Evaluation and Research, Kathryn Zoon, the director, said biological products are shaping the 21st century.

"This is being driven by a number of parameters, some of which include new discovery in biomedical research and technology. Billions of dollars are being invested by the government, predominately through the National Institutes of Health, for research and development for future technology," she said.

And although there is a demand for biotechnology products and faster access to them, Zoon said the greater demand lies in the safety and ethical issues surrounding the products.

In the upcoming year, Zoon said priorities of the CBER are topped by ensuring the safety and efficacy of biological products while facilitating their development and meeting goals of the Prescription Drug User Fee Act (PDUFA). Among other priorities, Zoon said CBER has the responsibility of rebuilding the public's confidence in the nation's blood supply.

"But what are our challenges for the future? If you read the newspaper you know some of the issues are gene therapy and some of the challenges of approximately a year ago are protecting human subjects and what we are doing for human subject protection," she said.

Zoon was referring to the September 1999 death of Jesse Gelsinger, of Tucson, Ariz., who died four days after researchers at the University of Pennsylvania in Philadelphia injected genes to cure a genetic metabolic disease called ornithine transcarbamylase deficiency.

And clearly, she said, the Human Genome Project will provide the opportunity for medical discovery, which raises ethical questions. Other challenges, she said, are stem cell products, emerging infectious diseases - making sure the blood supply is safe - and countering bioterrorism.

Consumers Help Shape Device Safety

As in its divisions that monitor prescription and non-prescription drugs, the FDA's Center for Devices and Radiological Health approves products for public sale based on their safety and effectiveness.

The basic strategy works through truth in labeling, premarket safety controls, premarket efficacy controls, postmarket study requirements, postmarket event reporting and standards conformance.

David Feigal, director of the Center for Devices and Radiological Health, said informed consumers play a role in improving medical devices through reporting adverse experiences, and serving as advisory panel members and on focus groups.

"Consumers play an important role for us, for example, when we have an opportunity to look at a device, like an implant that has been removed because of failure. If we can determine the reason for failure, then we can improve it," Feigal said.

He said through the Internet, consumers can remain abreast of FDA actions, data and research into products. "The majority of our web pages are oriented to manufacturers or medical professionals or consumers," he said.