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Watchdog And Innovator: Modernizing The FDA-Industry Relationship

As each medical advance introduces a new regulatory challenge, FDA’s need for reinvention is as constant as industry’s need for innovation. If the agency is going to help sponsors bring breakthrough medicines to market, it must rethink its role as both watchdog and regulatory innovator.

While the biopharmaceutical industry has embarked on a new age of accountability and personalization in medicine, Commissioner Margaret Hamburg, MD, and her predecessor, Andrew von Eschenbach, MD, have charged the Food and Drug Administration (FDA) with advancing regulatory science and innovation. Industry and FDA agree that to deliver innovative therapies, regulatory approval and drug development processes must keep pace with advances in biomedical research, medical technology, and health care delivery. Industry should view FDA not only as its chief regulator, but also as a partner in product development. In turn, the agency should strive to balance its dual role as protector (watchdog) and promoter (innovator) of public health.

The public dialogue addressing the effectiveness of the medical product approval process might suggest an adversarial relationship between industry and...

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