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Welcome to FDA, Dr. Hamburg

Dr. Hamburg, you have advantages that previous Commissioners did not enjoy. For the first time in decades, there will be extra money to spend, granted by a Congress that will continue to invest in FDA if they see a pay-off. You will be working in the first two years of an administration, when bold plans have the best chance of being realized. You are working for a president interested in public health, a rare event in the last 70 years.

It is not hard to predict that emergencies and crises will take up a lot of your time. So will the care and feeding of the Secretary, OMB, the President and Congress. FDA staff also needs attention, which you and Dr. Sharfstein have appropriately emphasized. There is likely to be tobacco legislation to implement and maybe a new food safety law.

In Long-term Challenges for New FDA Leadership, http://www.fdamatters.com/?p=171, I discussed some issues that may take years to complete, but should be started this year. I hope you will get to them.

Before you can do much long-term planning, you will have to deal with a backlog of policy issues and enforcement actions. This is to be expected when you are preceded by the end of an administration and by “acting” agency heads. Certain decisions just cannot be made until “permanent” leadership is in place.

More than any other activities, you will be judged in the short-term by how you handle the policy and enforcement backlog. These are the decisions that are most likely to animate external stakeholders. As a result, you may have to deal with misperceptions about your approach and your intentions.

Dealing with the back-log—perhaps as many as two or three major policy and enforcement decisions every week for several months—will strike many as hyperactive. They will extrapolate these actions into believing that you intend to govern that way. Eventually the pace will lessen into (merely) frenetic, but not before hard feelings may have set in.

You should communicate that you are dealing with a backlog, rather than planning to make so many major decisions on a regular basis. Emphasize, too, that most of the backlog was generated before you arrived, by FDA staffers operating under statutory or other imperatives. You agree with what staff proposed, but did not initiate it.

During Dr. Sharfstein’s first two weeks, he signed the Internet advertising enforcement letters and committed to a review of class III medical devices. Neither was a new issue. The public-released packages reveal upwards of a year or more of FDA staff work behind each. Nonetheless, some saw this as evidence of Dr. Sharfstein’s intent to be aggressive in confronting industry. A much better interpretation: these two issues waited for leadership that would be at FDA long enough to defend them.

Many of us hope that this is the start of a golden age at FDA. You are starting with a lot of good will and high expectations. To keep that momentum going, you and Dr. Sharfstein will need to act judiciously and communicate well as you work down the backlog.

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