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The Future of the FDA: Public Health in a Changing World

The Food and Drug Administration's regulatory goals are more complex than they were just a few years ago. At a Wilson Center Director's Forum on June 22, Commissioner Margaret Hamburg discussed her vision for strengthening the FDA's regulatory role and its ability to respond to import safety and other challenges of globalization.

"It's clear that the job of empowering FDA to fulfill its mission today is a fundamentally different and more complex proposition than it was even a few years ago," said Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, in an address at the Woodrow Wilson Center on June 22, 2010. "And one of my chief priorities as commissioner must be to accelerate the transformation of the FDA into a regulatory agency fully capable of promoting and protecting the health of the American public in the 21st century," she added. Her speech focused on the strengthening of regulatory science and the FDA's ability to respond to globalization, with particular emphasis on import safety.

Strengthening Regulations

In speaking about strengthening the regulatory powers of the FDA, Dr. Hamburg emphasized the FDA's role as an institution that provides guidelines that do not stifle innovation but properly ensure the safety of the public. She called for additional funding and attention for regulatory science, which she said "has been under appreciated, under developed and under resourced" despite being what she called a "dynamic and central part of our scientific enterprise and an important driver of both health and prosperity in our nation and around the world."

Hamburg dismissed the notion that regulatory science inhibits innovation, saying that the FDA is intended to "serve as a gateway to medical innovation, not a barrier." She commented that regulatory science can, when properly enacted, stimulate scientific innovation and developments and be a boon to the manufacturing process of new drugs and technologies. Specifically, she referred to the possibility of using developments in regulatory science in multiple products and stakeholders. "The knowledge generated from such [regulatory science] studies informs a whole body of innovation, rather than a single product," she said.

Hamburg pointed to several examples of FDA regulations at work, citing nanotechnology and stem cell research for Parkinson's disease as areas where the FDA effectively regulates industries to ensure public safety but does not interfere with innovation. In looking towards the future she said that the United States and the FDA "need new approaches but…cannot accomplish this task alone," referencing the need for more inter-country regulatory cooperation in a globalized world.

The FDA in a Globalized World

To meet the needs of a world that is increasingly connected, Hamburg stated that "public health must be a global endeavor." She cited the increasing percentage of food and drugs that are imported into the United States and the impossibility of the FDA being able to oversee every international food or drug manufacturer as evidence of the need for cooperation among other nations' regulatory agencies.

Elaborating on the topic when asked a question about international cooperation , Hamburg said that international regulators and the FDA need to harmonize their policies and regulation strategies, explaining that "harmonize doesn't necessarily have to mean that we do everything exactly the same…but we have to look at outcomes and we have to be able to say that the system you're using meets our standards and expectations for a safe, high-quality product."

When pressed further on the topic and asked about recent news reporting that many new medicines approved for sale in the United States were tested entirely or nearly entirely abroad, Hamburg responded by saying it is further evidence that international regulatory cooperation is necessary but also called data sharing from foreign clinical trials "an important advance" in increasing international cooperation.

By Drew Sample
Sharon McCarter, Vice President, Outreach & Communications

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