FDA Releases Regulatory Science Framework


At a National Press Club luncheon on Wednesday, Food and Drug Administration (FDA) Commissioner Margaret Hamburg released a strategic framework for FDA’s initiative to improve regulatory science and to create a new office dedicated to it.

The framework, outlined in a paper titled “Advancing Regulatory Science for Public Health,” seeks to improve FDA’s ability to effectively evaluate and regulate emerging products in the genomics and personalized medicine field, among other fast-changing areas of health care innovation. The goal of this effort, Hamburg said, “is to reduce the gap between the advances in science and the practice of patient care.”

Commissioner Hamburg pointed to the need to utilize the breakthroughs in genomics and tailored therapies to improve patient care. In particular, the new initiative will seek to expand collaborations with industry, academia, and other government entities to improve product development process and speed. It is hoped that this will reduce the time currently needed to bring new innovations into clinical practice.

Recognizing that innovation is increasingly focused on personalized medicine, these changes are designed to open the door to smaller, shorter clinical trials for targeted therapies, to speed the approval of new drugs, especially cancer drugs, for individuals with specific biomarkers.

In the words of the Commissioner, the FDA wishes to pragmatically evolve regulatory science to enable “21st century medicine” and “move out of a one-size-fits-all” paradigm of regulation.

Timothy A. Swope is the Policy & Communications Analyst with the Personalized Medicine Coalition.

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