And The Job of Reforming the FDA Goes To …

New York City health commissioner Dr. Margaret Hamburg is said to be President Barack Obama’s pick to head the U.S. Food and Drug Administration, the beleaguered federal agency rocked by criticism over its handling of recent outbreaks of tainted food and new-drug approvals.

A formal announcement is expected sometime in the next week, but officials with knowledge of the pick confirmed it and said that Dr. Joshua Sharfstein, the Baltimore health commissioner and Obama’s transition team member, will serve as Hamburg’s chief deputy.

Hamburg replaces Dr. Andrew C. von Eschenbach, who led the agency from 2005 until last January, and was often criticized for letting politics get in the way of deciding how the agency was run.

Fans of Hamburg aren’t waiting for the formal announcement to laud praise on the woman heralded as a strong leader who will put the interests of patients first and put the FDA back on the right track.

Hamburg Has Background of Public Service

Hamburg was appointed by former New York City Mayor David N. Dinkins as acting health commissioner in 1991 and became commissioner in 1992, a role she remained in after Mayor Rudolph W. Giuliani took office in 1994. During her term, Hamburg was best known for developing a tuberculosis control program that produced sharp declines in the incidence of the disease in New York and a rise in child immunization rates.

In 1997, Hamburg left New York to become assistant secretary for planning and evaluation at the Department of Health and Human Services, where she created a bioterrorism initiative and led planning for pandemic flu response.

Her father, Dr. David A. Hamburg, was a former president of the Institute of Medicine, she has two teenage children, and serves on the board of the Sidwell Friends School

A Long, Uphill Road

Hamburg is set to take over control of an agency that is at a low point, facing mounting criticism from lawmakers, physicians, and consumer rights groups. Critics point to the FDA’s handling of the recent outbreak of salmonella tied to peanut butter and peanut products as evidence that the agency is ill equipped to ensure the safety of the nation’s food supply.

Since the salmonella outbreak was first reported in late 2008, it has been linked to at least nine deaths, nearly 700 illnesses, and one of the largest recalls in U.S. history. The FDA has been widely criticized for failing to quickly detect the contaminated peanuts, failing to inspect the food-processing plants where the food came from, and reacting slowly to recall contaminated products.

Some legislators have called for the creation of a new federal agency charged with regulating the safety of food products, allowing the FDA to focus on new drugs and medical devices. The FDA has argued that it needs additional resources to keep on top of the emerging international drug business and the nation’s massive food-distribution network.

Regardless of what improvements must be made to restore the FDA to an agency up to the task of ensuring the safety of the nation’s food and drug industries, Hamburg appears to have the leadership, experience, and dedication to lead the way.

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