Dr. Sharfstein to Leave FDA on Friday

January 5, 2011

FDA Joshua Sharfstein

Dr. Joshua Sharfstein to Leave FDA on Friday, January 7th

Dr. Joshua M. Sharfstein, Principal Deputy Commissioner of the U.S. Food and Drug Administration, will be leaving FDA this Friday, January 7. Since joining FDA two years ago, Dr. Sharfstein has brought much needed energy and a passion for public health to FDA. Together with Dr. Margaret Hamburg, he has revitalized the agency, in my viewpoint, for the better. There are a lot of opinions about his leaving to become the Director of Maryland’s Department of Health and Mental Hygiene. I’ll let you scour the web for interpretations. I don’t have a clue. However, I would like to share his message to FDA employees about his departure:


From: A Message from the Principal Deputy Commissioner
Sent: Wednesday, January 05, 2011 1:30 PM
To: FDA-Wide
Subject: Thank You

Dear Friends and Colleagues,

Just over two years ago, I was led through the Parklawn Building to a small, windowless room known as 15B08. Over the next few weeks, our small group on the Obama transition team met there for many hours with dozens of FDA staff, and then elsewhere with industry representatives and patient and consumer advocates.

Amidst hundreds of individual notes, we heard one melody: broad support for a strong FDA that protects and promotes public health.

Two years later, this melody can be heard at White Oak and in the agency’s offices around the country and across the globe. FDA now has the public health responsibility of tobacco regulation, a new law that will transform the food safety system, a renewed commitment to innovation in regulatory science and the regulatory process, and a growing reputation for transparency, accountability, and action.

In these two years, I have come to understand that FDA can succeed beyond everyone’s expectations by developing and explaining the public health logic underlying key regulatory steps.

I have found that by communicating like a public health agency – directly, clearly, and with credible partners – FDA can generate support and make further progress.

And I have seen that good judgment is as important as good data. It is good judgment that can answer the essential question of when the agency has enough data for action.

Through FDA-TRACK, the transparency initiative, numerous crises du jour, trips to regional and district offices, and other settings, I have had the pleasure of working with many remarkable FDA staff. I appreciate all of your patience and understanding during my first few months, and all of your dedication and accomplishments over the last two years. I know that even more progress and innovation is in store to benefit patients and consumers across the country.

It has been an honor to serve in the Administration of President Obama and Secretary of Health and Human Services Kathleen Sebelius.

And it has been a special pleasure to work for and learn from Dr. Margaret A. Hamburg, a leader with extraordinary judgment, kindness, and vision.

My tour at FDA is, however, coming to an end this Friday. Recently, Governor Martin O’Malley offered me the opportunity to serve as Secretary of Maryland’s Department of Health and Mental Hygiene, and I accepted. I will start next week in time for the state’s legislative session. My new role will span a wide range of exciting and important areas, including public health, mental health, substance abuse, developmental disabilities, Medicaid, and healthcare reform.

I would say good-bye — except that I will not be far away.

Dr. Hamburg has even invited me to run in the upcoming White Oak Classic, the annual 5K run around the campus. This has been an annual event that celebrates health and fun, and involves, for me, no small amount of personal humiliation.

I am in training for the race . . . and I hope to see you there.

Thank you, and take care,


Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
U.S. Food and Drug Administration


GxP Perspectives wishes Dr. Sharfstein all the best at his new job.

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