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Commissioner Hamburg’s New Year Memo to FDA Staff

The following is the full text of Dr. Hamburg’s “new year memorandum” to all FDA staff, issued on January 7, 2010.

From: A Message from the Commissioner
Sent: Thursday, January 07, 2010 7:12 AM
To: FDA-Wide
Subject: A New Year

The beginning of a new year is a good time to take stock of what we have done over the past 12 months and where the next year will take us. Upon my arrival at FDA in May, I found myself distinctly impressed by this agency’s enormous impact, both as a regulator of so much of the American economy and as an organization upon which so many depend for the safe use of a wide array of products critical to their daily lives.

I recently observed to Secretary Sebelius that I have found FDA’s employees to be a wonderfully talented and dedicated group that I believed, if adequately resourced and supported, could solve virtually any problem that comes your way. The Center directors, ORA, and Commissioner’s staff offices recently shared with me their accomplishments for 2009, and it’s a remarkably impressive list of product reviews, inspections, enforcement activities, rulemaking, outreach to the public and those we regulate, reaction to crises and so many other activities that enable the agency to be an effective public health protector.

All of that was done as a cascade of new challenges were thrust upon us – H1N1 influenza, implementation of the new FDAAA and animal drug legislation, new food contamination and drug registration systems, and an entirely new Center to regulate tobacco for the first time in the nation’s history. I should also note that lurking out there are new requirements in the health care bill moving through Congress (e.g., “follow on” biologics and restaurant menu labeling).

Of course, we launched a number of new things ourselves – new foreign offices, a safe use initiative for drugs, a new food labeling effort, a reexamination of the process for reviewing medical device 510(k)s, new procedures for emergency response, a new policy with regard to antimicrobial resistance for animal drugs, and a rejuvenation and integration of the food safety program, to name just a few. New facilities also came on line in 2009, most notably the medical device office and laboratory complex at White Oak and the Bio-Imaging facility at NCTR.

For my part, I am proud of the new emphasis that Josh Sharfstein and I have placed on ensuring FDA’s reputation as a public health agency, as an organization more transparent to the outside world, and as a regulator intent on its scientific integrity and on enforcing the safety standards we have been charged with implementing.

All of the things that I have mentioned above will, of course, be a priority for 2010 as well. But I also intend to dedicate myself to giving you more and better tools to do your jobs. This will include seeking Administration support to improve our regulatory science, ensuring passage of the food safety legislation now before Congress, seeking new authorities to better regulate imports, and identifying changes in our medical device statute that are needed to ensure that program has 21st century capabilities. I also intend to urge the Administration and Congress to complete the long-awaited consolidation of our headquarters facilities at White Oak and College Park. And, of course, getting you the resources and staffing necessary to be successful will be a constant imperative, despite the demands to reduce Federal spending.

I have gone on long enough, even though I have barely touched upon the hundreds of discreet activities that FDA staff carry out every day. I will close simply by saying that I consider myself privileged to serve as your Commissioner in this great enterprise we are about. I pledge to you the same dedication that you have shown to the American people. I am proud to be associated with you and with the Food and Drug Administration, and that I hope the new year is as filled with accomplishment and progress as the old.

With all best wishes for a happy, healthy and productive new year.

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs