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.
Its not really fair to talk about agency bungling without mentioning the Provenge matter. What is worse than what happened pre and post AC is that the Agency has been unwilling to review the matter and decide the CareToLive Citizen Petition seeking relief for the patients.
Patients continue to be without a voice at an agency that dictates to them what they can and can’t access even when there are no options for that patient, other then death without ability to fight for their life.
FDA is a public health agency first and foremost, yet that has barely been in its agenda for the last 8 years. We were even preached to that our customer was the drug industry. However, in the trenches, we all knew that was wrong. Quite the contrary. We are the customers, or proxy-customers, representing the public who consume foods and drugs. Short of each patient doing their own oversight, we are all they have to ensure safe and effective drugs. Perhaps once Dr. Sharfstein straightens it back out and makes our foods and drugs safe again, everyone can get back to politicizing it and turning it back over to the short sighted business interests of the MBAs in the drug industry. But lets fix it again first.
I am also very hopeful with Dr. Hamburg’s nomination. As a former FDAer I really want to see her succeed. We certainly need it. However, if she is, then Congress needs to do its job in appropriating enough money and to help modernize FDA’s regulations.
Carl from Carl’s Blog on FDA Stuff:
http://carl1anderson.wordpress.com/