As speculated last week, it is not official, but it is. Dr. Margaret Hamburg, former head of the NYC Department of Health, and Dr. Joshua Sharfstein, current head of the Baltimore Department of Public Health, will be appointed by President Obama to head the FDA as Commissioner and Deputy Commissioner, respectively. That way, if Dr. Hamburg wants to leave (and who wouldn't) after taking the job, there is a groomed and guiding hand at the helm to step in who is both qualified and can carry the torch in the same direction.
These are welcome appointments and frankly, are the kind of medicine needed. Since 2002, the FDA has seen its once gold standard reputation heavily tarnished by the strains of a string of mis-steps and mis-haps, beginning with the COX-2 inhibitors issues, labeling for anti-depressants, the closure of a flu vaccine facility by the British medical authorities where the agency only found out after the fact, a string of whistle-blowing employees claiming an assortment of allegations from devices to drugs, surveys of employees revealing high levels of low morale, a woolly Congressman knocking on the door to HHS demanding records with camera crews in tow, Congressional critics exploiting the agency's weaknesses to stage political drama, the Hill using the agency as a punching bag, the mess with Avandia, the mess with Ketek, a series of GAO reports that showcase weaknesses in the agency's oversight of food safety, device approval and on and on, all occurring while the agency was headed by anemic leadership. In addition, the agency is struggling to catch up to the events that are going on around it.
These are the kinds of challenges faced by the Obama Administration on a broad front – two wars, economy in tatters, healthcare system in need of reformation, etc. It seems like anyone appointed to anything in this Administration has a near herculean task ahead of them. Who would want to be Timothy Geithner
right now? Anyone?
There is every indication by her past, that Margaret Hamburg is up to the task. Her years as Director of the New York City Department of Public Health occurred at the height of the AIDS epidemic before there were any effective treatments for the disease. The entire scope of that job is not dissimilar in nature to the breadth of the scope she faces now. It was a very tough, very political atmosphere. She has the backbone for this job and it will remain to be seen whether she has the vision and the depth that will be needed to match the breadth of what needs to be accomplished.
She and Dr. Sharfstein have a great deal in common. Both heads of health departments of major cities, both children of physicians, both in the Institute of Medicine – that will support the notion of their moving together in lock step to exert leadership over an agency that has been largely rudderless since the Clinton Administration. They will have to move in many directions at once and frankly at breath taking speed to restore the agency to its former self and hopefully beyond.