Acting Chief Scientist says agency needs to develop partnerships.(Science)

WASHINGTON, DC -- In very frank commentary on the state of FDA's reputation among American consumers, Acting Chief Scientist Jesse Goodman, M.D., told the FDLI annual meeting in Washington that partnerships may be the key to restoring confidence in the agency.

"I think that FDA has often been seen as a black box," said Goodman "Some of this is about the laws we are held in, but some is about the culture and about how we view our role. We're often seen confined by a regulatory message. We need to be seen as giving a public health message that everyone can understand. With transparency, we make better decisions."

He said there is a long road ahead for FDA as it builds back the trust lost by many Americans. People are uncertain about the purity of the drugs they take, the safety of the foods they eat. With such great responsibility already on its shoulders, how well the agency will fare regaining public trust remains to be seen.

In a way, the agency's overhaul is a back-to-basics move. There is the fundamental issue of defining safety and how it can be achieved, and the understanding that safety is not absolute. "Even when we have something that has a very good risk/benefit ratio, there are uncertainties," said Goodman.

As changes continue at the agency, such as an influx of new personnel, efforts to regain its once reputable status are underway. "Integrity is precious," said Goodman. "It leads to trust, and [once broken] it's hard to repair."

Protecting the safety and health of the public is a great responsibility, one that the agency has devoted its resources, time and complete efforts to fulfill. But in recent years FDA has sought out support--the experience and skills of federal agencies, corporations and educational institutions--to enlist the trusted experts of public health organizations overseas.

Partnership may be the agency's best approach to promoting safety, Goodman said. The more trusted players involved the better, he said. "It's not industry, FDA, academia, etc. Together we really are a system. We have to reach for common goals and collaboration and not get into fixed positions. We need to adapt to new information and change needs to be part of our inherent processes."

For FDA, the benefits of partnering are many, but perhaps most important is the potential for boosting prevention. Opportunities for avoiding adverse events and drug-related illness come by way of social policy, education and research. A better understanding of genetics and medicine has launched the field of personalized medicine to new levels. Scientists are turning their focus to individual responses and population variability to provide truly customized care.

"Most people are focusing on preventing harm or promoting effectiveness," said Goodman. "We need to start to define groups--populations--as the therapeutic targets."

So much complex data and a wealth of information at their fingertips have given scientists a very real opportunity to transform the fields of health care and medicine. But with complexity come basic needs: more hands, better organization and clearer concepts.

"The complexity of things requires appropriate partnerships," said Goodman. "The social and behavioral sciences are critical. If we don't get engaged, we will lose both in terms of markets but also our nation's health and also on our opportunities to help others."

Said Goodman, everyone will benefit from greater input, clearer explanations of rationale, increased testing and more debate.

Goodman recognized the struggles that face FDA in its pursuit of transparency, but spoke positively about the agency's objectives. "I believe that transparency and communication, though they may be challenging in the short run, are great even in the face of uncertainty," he said. "Culture is a huge thing that everyone has to be attentive to--a culture that sees the public health outcome, not just risk/benefit."

By Carrie Nathans

Managing Editor

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