Reviewing the US FDA as Commissioner Hamburg completes first year in office: NEJM perspective

In a Perspective piece published on-line this week in the New England Journal of Medicine, Georgetown University School of Medicine, USA, family medicine physician Susan Okie gives a comprehensive overview of change, and planned change, within the Food and Drug Administration. The review comes as the FDA's commissioner, Margaret Hamburg, completes her first year as the agency's leader.

Dr Okie writes that the FDA'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…" To that end, Dr Hamburg reportedly has spent hundreds of hours meeting with interest groups and meeting with key members of Congress to build alliances.

As Dr Okie outlines, Dr Hamburg and the deputy commissioner, Joshua Sharfstein, have already undertaken several changes at the agency. The two leaders 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. In nonemergency situations, changes that have been described as "nuanced" actions often achieve desired results, Mr Sharfstein says.