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“The Principal Makes the School” and Other Thoughts for the New Tobacco Center

My experience has been that “the principal,” not the teachers, is the key to having a great school. Outstanding principals attract the best teachers and get maximum performance from everyone. The point for Dr. Hamburg: picking the right director for the new tobacco center is your only mission-critical job. All the other details can be handled by your staff and the new center director.

Here are some of the keys to successfully implementing the new tobacco legislation:

Minimize transfers from other parts of FDA. This probably violates some important management principle about letting people bring their talents to the job that interests them most. Still, FDA’s budget is growing quickly and its responsibilities even quicker. There are dangers to FDA’s overall mission if existing teams are diluted by a large number of transfers to the new center.

Manage the new tobacco center as if it were a separate agency. There will be crises and hearings, complaints and campaigns aimed at the tobacco center. FDA needs to create a self-sufficient center that minimizes the distractions for the rest of FDA. There is one reality that cannot be avoided: the Commissioner has only 24 hours per day.

Audit-proof the accounting for the tobacco user fees. It is 100% certain that there will be challenges as to whether the user fees are accurately paying for all the costs. FDA should bring in someone from outside (maybe from GAO or a big accounting firm) to create a cost accounting system that is parallel to, but separate from, the rest of FDA

Let’s return briefly to the question of picking the best “principal” to head the new tobacco center. Ideally, the person would have broad governmental experience, close-up familiarity with FDA, a public health and regulatory perspective and the presence and stature not to dissolve during a critical press conference or a heated Congressional hearing.

The inclination may be to hire a public health leader who has led the fight against smoking. Unfortunately, most of these leaders lack experience as regulators.

Kate Rawson of the RPM Report floated a name in March that should be given serious consideration: Dr. Steven Galson, the acting surgeon general. She cites his experiences at CDC, EPA and as head of CDER at FDA.

I don’t know whether he is interested and this is not an endorsement. Dr. Galson does have the ideal credentials I have suggested: broad government experience, close-up familiarity with FDA, public health and regulatory perspective and the gravitas and presence to handle the heat. He has the added advantage of not depriving FDA of existing leadership in order to staff the tobacco center. Another name being discussed: Mitchell Zeller, a former associate commissioner and director of the FDA’s Office of Tobacco Programs. While not a physician, he also has many of the characteristics that Dr. Hamburg should be looking for.

Kate’s RPM column can be found here:


One Response to ““The Principal Makes the School” and Other Thoughts for the New Tobacco Center”

  1. Yesterday, friend and fellow blogger, Merrill Goozner also wrote about the new tobacco law. In part, his column reports on the views of long-time FDA editor/reporter, Jim Dickinson, who believes that the new tobacco jurisdiction “will be like a death sentence, steadily killing the agency’s old public health spirit….” In a post to Merrill’s site, I have respectfully disagreed, suggesting that the public health spirit will be just fine with the new leadership, backed by appropriations levels that permit the agency to do more. My recommendations (in the post above) are to make the center wholly self-sufficient and prevent a drain on the human resource needs of the rest of FDA.

    Merrill has asked his readers within FDA for feedback on what they think the impact will be and whether they agree with Jim. I would like to extend the same request to my readers, broadened to include anyone who has worked at the agency within the last 5 years. You can write to Merrill at merrill@gooznews.com or to me at sgrossman@fdamatters.com or post comments right here. Your comments will not be attributed to you personally, but will help Merrill, Jim and me comment more accurately about agency changes as a result of the tobacco law.

    Merrill’s article and my comment are at: http://www.gooznews.com/node/2959#comments. If you want to subscribe to free weekly updates from Merrill, there is a sign-up box at the upper left. Jim Dickinson’s news coverage and insights, based on 30 plus years in the business, are in FDA Webview, http://www.fdaweb.com/default.php?ea=aboutus (subscription required). If you are a visitor to my site, go to http://www.fdamatters.com or click on the logo at the top of the page. There will be a “register” link at the top on the right.

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