Change Agent

Jan 06, 2010

The role of FDA Commissioner has in recent years become a graveyard for professional reputations, with occupants of the post roundly criticized on everything from undisclosed ownership of drug industry shares to failure to anticipate the presence of salmonella in tomatoes and hot peppers. In terms of impact on the public at large, the post ranks near the top of the executive branch, as the agency's regulatory mandate covers more than a quarter of all consumer-led economic activity in the US. Yet despite this high profile, Commissioners spend much of their time negotiating the boundaries around Congressional mandates that amount to "mission creep" accompanied by ad hoc—and never sufficient—additions to already constrained resources.

In office for six months, Commissioner Margaret (Peggy) Hamburg believes that a more focused public health orientation, diverse management, and an organization-wide commitment to following good science will break the bureaucratic model of "best enough and no more," restoring the FDA as an exemplar of government efficiency and responsiveness. Not surprisingly, Hamburg's main complaint is that she has only 24 hours each day to accomplish all these tasks. But last month she took time from her schedule to discuss her priorities and policies in a one-on-one interview with Pharmaceutical Executive at FDA's campus in White Oak, MD.

— The Editors

One of the first things one notices about Peggy Hamburg is her candor. When the Obama administration rolled in at the beginning of the year, Hamburg admits she was not on any short list of possible FDA commissioners. Although she had been in and out of Washington research institutions and health agencies for 30 years, she was not closely associated with FDA, with clinical research, or with food and drug regulation.

But she had top credentials in the public health community, was an expert in bioterrorism, and presented an attractive mix of medical training, government service, and management experience at a large city (New York) health agency. The White House wanted an outsider at FDA to tackle food safety, tobacco marketing, and the looming influenza pandemic. The fact that she had no ties to the drug industry was also a plus.

Hamburg sped through the Senate confirmation process last May, with the same candid style in which she readily admitted she was unfamiliar with many of the complex issues raised by the legislators. Her earnest approach drew plaudits from Senators on both sides of the aisle, and her confirmation marked a note of contrast with the recent past: Support was bipartisan and quickly rendered. The new Commissioner kept up the momentum with a well-timed message of solidarity with FDA staff, as well as securing a hefty budget increase.

She and deputy commissioner Joshua Sharfstein co-authored a May 26 editorial in The New England Journal of Medicine that cut through the bureaucratic murk to lay out FDA's central role in protecting public health. It advanced three major policy themes: FDA should (1) help advance science for the products it regulates; (2) assess imported food and drugs more thoroughly; and (3) minimize the risks associated with pharmaceuticals through education, regulation and enforcement. The underlying message is that FDA should not be measured by the number of facilities inspected or drugs approved, but by how well it meets the larger goal of promoting health and preventing illness.

Before Hamburg's confirmation, there was speculation that she and Sharfstein, who ran FDA during the first months of the Obama administration, would divvy up agency oversight and operations, with Hamburg handling food and tobacco, and Sharfstein overseeing drugs and medical products. Again, in a burst of candor, Hamburg moved to dispel such notions, asserting that if confirmed, "I would be the Commissioner."

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