NEJM: Changing face of FDA will continue to evolve

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Susan Okie, MD, offered a comprehensive overview of ongoing and planned changes within the FDA, in a perspective published Oct. 7 in the New England Journal of Medicine. The review comes as the FDA’s commissioner, Margaret Hamburg, MD, completes her first year as the agency’s leader.

The agency's priorities over the past year have included “finding ways to make the FDA more nimble and proactive, restoring its credibility and refocusing staff on its public health mission, persuading Congress to boost funding for its expanding portfolio of responsibilities, [and] sharpening its ability to deal with new science and globalization,” said Okie, a family medicine physician at Georgetown University School of Medicine in Washington, D.C.

Hamburg reportedly has spent hundreds of hours meeting with interest groups and members of Congress to build alliances, Okie wrote.

Hamburg and the deputy commissioner, Joshua M. Sharfstein, MD, also have met with FDA employees to understand hurdles they encounter because of legal and regulatory requirements. Such discussions have prompted new measures to accelerate responses to urgent health threats, Okie reported.

Hamburg, Sharfstein and internal task forces have been “re-examining the processes for making decisions” about the safety and effectiveness of drugs and medical devices. The agency is awaiting reports next year by Institute of Medicine panels that are likely to recommend reforms. The leadership anticipates decisions that could lead to lasting changes at the agency.

Finally, Hamburg's longer-term priorities include regulatory science and globalization. In addition to advocating for increased funding, the agency hopes to collaborate with scientists in academia and industry, as well as other federal health agencies, on research and training in areas such as biomarker, bioimaging, clinical-trial analytics and pharmacoepidemiology, Okie stated.

As for globalization, the FDA is introducing a risk-based strategy for targeting priority inspections in order to “grapple with the expanding task of ensuring the safety of products … made overseas,” Okie concluded.