FDA Matters Blog
Register to get regular updates from FDA Matters FDA Matters Home

Fortuitous Timing and Public Health Leadership at FDA

At the end of March, Commissioner Hamburg will have been at FDA for 10 months and Dr. Sharfstein for a year. They are very good leaders who have also benefitted from their prior experiences and the timing of their appointments. Here is FDA Matters‘ analysis:

Public Health vs. Academic Medicine. Since at least the mid-1970’s, FDA commissioners have come from academic health centers or government. Not one had run a public health agency at the federal, state or local level. In contrast, Dr. Hamburg spent 6 years leading the New York City Health Department. Dr. Sharfstein was recruited from his job heading the Baltimore City Health Department.

The difference is largely unappreciated. Running an academic health center is inwardly focused, with the goal of making a highly-complex institution run well. The primary outputs are patient care, research, and teaching.

Power in an academic health center is widely shared and interaction based on collegial ties. External forces, particularly the government political process, are often intermittent and remote and crises rarely come from outside the organization. Accountability is a virtue, but often not a requirement. Diplomacy and people management are the primary skills.

In contrast, a city public health agency is externally focused, with the goal of improving the health of a population. The primary outputs are programs of intervention and education, along with regulations. The structure in a public health department is hierarchical at every level.

The commissioner is integral to the political process and must be responsive to the Mayor and the City Council. External forces drive much of the activity. Crises are so frequent as to become routine and accountability is a necessity. Diplomacy and people management are valuable skills, but the premium is on concrete actions occurring in real-time, even if someone’s feelings are bruised.

FDA is very much like a big-city health department, only minimally like an academic health center. This gives an enormous advantage to Drs. Hamburg and Sharfstein.

FDA in 2010: A Chance to Grow Stronger. In a hostile and uninterested environment, the very best leadership can survive, but not prosper. The new FDA leadership team is fortunate to have the best situation in 30 years for improving FDA.

FDA’s budget has grown over the last three fiscal years, providing the new Commissioner with resources to strengthen the agency and prioritize initiatives. Over much of the prior two decades, the agency received annual increases close to, or below, inflation. There is not much new you can do when you are struggling to fund pay raises and rent increases.

Further, it matters when a Commissioner serves in the Presidential life cycle. As a rule, there is a lot of policymaking in the first few years of a Presidency and comparatively little in the later years. If policy improvements are to be made at FDA, 2010 is the time.

In addition, President Obama is alone among the post-war presidents in his interest in public health. Inadvertently, this was reinforced last year when he had to handle the peanut crisis himself because there were no confirmed appointees at DHHS. President Obama knows what FDA does and has a feeling for why it is important.

None of this is to take anything away from Drs. Hamburg and Sharfstein. They deserve credit for progress occurring at FDA. They are fortunate to have experience and timing that are likely to take them further than most of their predecessors.



Leave a Reply

You must be logged in to post a comment.

© 2009-2012 by HPS Group. All rights reserved. Permission is hereby granted to those wishing to quote or reprint from this site, providing it is properly attributed to FDA Matters: The Grossman FDA Report™.