FDA’s New Outbreak Director: Learning from Outbreaks is the Key

The best way to get into the Gulf of Maine in August is to jump feet first. So, “jump feet first” is what I did this week on my first day as chief medical officer and director of outbreaks for the FDA Coordinated Outbreak Response and Evaluation (CORE) Network.
CORE, with a dedicated multi-disciplinary staff, is meant to provide a streamlined, integrated approach to how FDA not only responds to human and animal foodborne illness outbreaks, but how we improve surveillance and post-response efforts, to apply lessons learned and prevent future outbreaks. When an outbreak happens, the CORE staff will decide the strategy of FDA’s response, working closely with the FDA field staff, and coordinate with other key federal, state and local food safety agencies.
After 28 years as Maine’s state epidemiologist, the management of outbreaks is vital to me, but even more important is learning from them in order to prevent or minimize future outbreaks. That’s what public health’s emphasis on preventive medicine is all about.
So, when asked what I wanted to do on my first day, I said hear firsthand from some of our partners, both inside FDA and outside.
I was able to briefly introduce myself to a crucial component of the CORE Network – the FDA Regional and District offices, during one of their regular weekly conference calls. CORE is already coordinating and will continue to work closely with the Districts during outbreak response and related activities, building on the best of what FDA has done in the past, and finding ways together to improve and streamline our efforts going forward.
I was also able to visit with the director of the Office of Crisis Management for the Agency, which will continue to play the lead role in responding to natural disasters and other incidents. I toured the Emergency Operations Center and talked with the director and staff to assure them that CORE will continue to work closely with this crucial office in the future.
Key consumer groups, including two organizations representing foodborne illness victims and their families, also shared their insights with me and my FDA colleagues. Two of the members of these groups spoke movingly of the deaths of their children from contaminated food and how they vowed to use their experiences to improve food safety for all American families.
As a mother of four children, I listened and tried to imagine the grief they have experienced. Having investigated numerous foodborne outbreaks at the State level, I have experienced the frustration of being unable to identify the “culprit”; or, when successful, wondering how food contamination could ever have occurred in this modern world; and wishing that the “lessons learned” from the outbreak could have been translated into effective preventive recommendations and policy. After hearing their stories, the “why” of food safety has never been clearer for me.
This commitment to food safety was also the theme of a call with industry representatives who spoke of the critical knowledge they can bring to bear in times of a foodborne illness outbreak.
For instance, two of the large trade associations representing the produce industry spoke about the wealth of information they have on produce and how they want to make certain FDA has access to and is able use this valuable data they have before, during and after an outbreak.
A large group representing retailers echoed this commitment to sharing information throughout our conversation, as well as making certain the industry’s “knowledge factor” is used in outbreak response. We all reiterated the importance “of learning in retrospect” from outbreaks, and I shared with them that this was a lesson I had learned early on in my work in preventive medicine.
Meetings with new colleagues at FDA and on the calls with some of our stakeholders also gave me an opportunity to reflect on the historic shift taking place in food safety. The FDA Food Safety Modernization Act squarely puts in place the public health principle of prevention as the foundation of all our food safety efforts.
It’s an historic shift not only for those of us in government, but also for industry. And prevention is key for all of us, as Commissioner Hamburg and I agreed when I had the opportunity to chat with her the next morning. It is especially important in today’s world, where our food supply is global as well as local.
Bracing and exhilarating would be my words for that first day – just like that Gulf of Maine. And it’s what I was hoping for.
Dr. Kathleen F. Gensheimer, M.D., M.P.H.,
Chief Medical Officer
Outbreak Director
The best way to get into the Gulf of Maine in August is to jump feet first.

As an advocate for self healing I often wish for less not more of the medical arts but in your case I make a clear distinction. Rapid response from your department can and will save lives. I wish you every success and all the co-operation you need to accomplish the task.
Treating foodborne outbreaks is tough, especially since it’s really hard to find the source of it. I hope you will find ways to fight it, especially with the recent lethal melon case.
Good luck on your new job!
Nadav
That’s really cool article
Thanks Dr. Kathleen F. Gensheimer
Good! I wish you every success the world.
I have been reading about your new program of FDA at http://www.fda.gov/ForIndustry/FDABasicsforIndustry and I am motivated to give a comment on this new FDA programmes. As a young pharmacist who is going to be graduated from endustrial pharmacy from Ankara University, I would like to ask you is there any training that you would give for efficient and effective drug manufacturing techniques. I am highly interested in doing a lot of reasearch in such drug production fields and do a great deal of commitment and participation for such development programmes . Do you have any training and capacity building programmes? I honestly suggest you should have capacity building training and study projects in which you can include and give a chance to participate committed and potential candidates and related scientists from different parts of the world.
Good for you on the sensitivity and determination
tomer
Awsome article! Good luck!
Kathleen, Great to see you getting out there on your first day in office.
Now that to me is a “hands on” approach.
Regards
Seo
Wonderful article.Very interesting topic indeed. Thanks to the author for explaining the facts so lucidly.
This is good reading we need to do all we can to prevent and be prepared for an sort of out break that might occur.
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Sounds good to learn from that, yep.
It was interesting to read. Good article, good luck.
Hi Dr. Kathleen. It’s nice to see that a very important position fell on a responsible and sensitive person like you. Wishing you success on your new position.
What a fresh piece of information on business. Cheers
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I hope you will find ways to fight it, especially with the recent lethal melon case.
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which you can include and give a chance to participate committed and potential candidates and related scientists from different parts of the world.
Great article! Hope you will find a remedy for it. This sort of outbreaks can be devastating.
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Although it is possible that the future will bring a more contagious, deadly form of SARS, it is certain to bring influenza and other infectious diseases, some of which may be introduced intentionally. Recognizing that it would be impossible to address the vast array of potential microbial threats individually, public health policy makers are formulating strategies to evaluate and respond to outbreaks of all kinds.
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