Industry’s involvement in prioritizing goals is one of the most important steps.

When the FDA received a funding increase of $275 million in the 2008 supplemental budget, the challenge became how to best utilize those funds. Speaking at BIO Wednesday in San Diego, a panel of former FDA executives noted that responsibilites and complexity have expanded, while the commitment to ensure the safety of pharmaceuticals and food, as well as to support continued innovation, are unchanged.

To focus its priorities, the FDA is working with industry to prioritize goals. As Scott Gottlieb, M.D., FDA deputy commissioner from 1990 to 1997, noted, “We’ve lost the view of the FDA as an enabler of change,” but it’s a central factor to unleashing innovation. Yet, from a communications standpoint, trying to protect health through establishing pathways for drugs to come to market is poorly articulated.” Congress asks whether the Agency is up to the task. The answer? “We’ll find out,” quipped Bill Schultz, FDA deputy commissioner for policy from 1994 to 1998.

“The safety issues of the last several years have been front and center,” noted David Kessler, M.D., commissioner of the FDA from 1990 to 1997. “Complexity has increased, and toleration of risk has decreased,” Dr. Gottlieb elaborated. With societal expectations bordering perfection, Dr. Gottlieb suggested that such expectations may be unrealistic. “That’s a fundamental question to grapple with. Can we get to a perfected regulatory system?”

Broadly enhancing the safety of the foods and drugs it regulates is one of the reasons behind the FDA’s spring announcement to open an office in Beijing. Currently, there is a lack of on-the-ground information that could mitigate risks, Dr. Gottlieb explained. “This issue isn’t just for China, but for India, South America, and other regions, too.”

Achieving the FDA’s mandate to improve food and drug safety and modernize its own operations will “take significant leadership and vision. We don’t want to have a void of leadership that traditionally ranges from 12 to 18 months,” Dr. Kessler emphasized. To that end, the FDA and BIO are both working with the Democrat and Republican Presidential candidates now to ensure they have a good understanding of the issues facing the FDA and biotech industries so that, on inauguration day, the new President can hit the ground running.

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