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U.S. Department of Health and Human Services

Animal & Veterinary

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Dr. Bernadette Dunham Takes the Reins as CVM’s New Director

by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No VI

Referring to her as a “world class scientist and leader,” Commissioner of Food and Drugs Dr. Andrew von Eschenbach appointed Dr. Bernadette Dunham to head FDA’s Center for Veterinary Medicine, effective January 7, 2008. She steps up from Deputy Director of CVM, replacing Dr. Stephen Sundlof, who was appointed to head the Agency’s Center for Food Safety and Applied Nutrition, effective the same day.

With extensive experience in the food safety and protection area, Dr. Sundlof is well suited to serve as CFSAN’s Direc-tor. He provided significant input into the development of FDA’s Food Protection Plan that was unveiled last year, and has also been instrumental in putting strong animal feed programs into place to prevent Bovine Spongiform Encephalopathy (BSE) from entering the United States. He led CVM for 14 years, and will be sorely missed by all who knew and worked with him there. One of his legacies at CVM will be the implementation of the principals of “High Performance Organiza-tion” (HPO), which all CVM employees are encouraged to live by and which has engendered the fairly widely heard man-tra of “CVM is the best Center to work for.”

But who is Dr. Dunham, what makes her tick, and what keeps that energetic bounce in her step all day long? I had a chance to sit down with this remarkable dynamo recently to get some answers to those and many other questions.

First of all, she is no stranger to CVM, having worked closely with Dr. Sundlof in her role as Deputy Director since 2006. She has played a critical role in coordinating and establishing Center policy in research, management, scientific evalua-tion, compliance, and surveillance.

She has also been serving as the director for CVM’s Office of Minor Use and Minor Species (MUMS) Animal Drug De-velopment. This is the office that oversees drug development for such species as zoo animals, ornamental fish, parrots, ferrets, guinea pigs, sheep, goats, catfish, and honeybees. The MUMS office also oversees drug development for un-common diseases in the major species: cattle, pigs, chickens, turkeys, horses, dogs, and cats.

Dr. Dunham has turned over the position of Director of the Office of MUMS to Dr. Meg Oeller, who will serve as acting director. Dr. Oeller has been part of the MUMS office since it was initiated.

No stranger to veterinary medicine

Dr. Dunham, who holds a Doctor of Veterinary Medicine and a Ph.D. in cardiovascular physiology, joined CVM in 2002, serving as the Deputy Director of the Office of New Animal Drug Evaluation. Prior to this, she served in several important leadership positions with the American Veterinary Medical Association and held faculty positions at several universities, including in the Department of Pharmacology at the State University of New York Health Science Center at Syracuse. Early on, Dr. Dunham worked as a veterinarian in private practice, so she has seen just about every facet of the profes-sion – hands-on veterinary work, research, teaching, congressional liaison work, and federal service. She brings to the Director position, not only exemplary credentials, but also a true passion for human and animal health and for carrying out FDA’s mission.

“I pinch myself every day since Dr. Sundlof passed the CVM reins to me,” Dr. Dunham enthusiastically commented. She said she is excited about continuing the many projects and initiatives that Dr. Sundlof has put into place as CVM Di-rector over the past 14 years. The new CVM Director freely expressed her sincere enthusiasm about working with what she terms “incredibly dedicated and talented people” at the Center. She also said that she is anxious to put “our face” in public view so that CVM’s many stakeholders can see for themselves who we really are.

Meeting certain challenges head-on are priorities for 2008. Most notable of these is addressing food and feed safety in light of the melamine incident of 2007 and the directives from Congress that are embodied in the recently enacted legisla-tion (“The Food and Drug Administration Amendments Act of 2007” [FDAAA]) designed to ensure that melamine-type scenarios do not present themselves again.

Pet food recall was a learning tool

“CVM does not work in a vacuum, and we will be interacting with our partners on this new food safety initiative, includ-ing feed groups, pet owners, pharmaceutical companies, and the public – something I truly look forward to doing,” Dr. Dunham stated. She spoke of the many lessons learned from last year’s massive pet food recall that was sparked by the melamine-contaminated wheat gluten in so many products. The recall is one of the more significant driving forces behind FDA’s Food Protection Plan, the key tenets of which are prevention, intervention, and response. Dr. Dunham noted that during the pet food recall, FDA found itself responding first, and then looking at intervention and prevention measures. With FDA’s Food Protection Plan, prevention will be the first step, thus reducing the need for intervention and response.

Another lesson learned from the pet food recall, according to Dr. Dunham, was how integrated the Agency’s animal feed and human food systems really are. “We saw how the feed distribution chains are complex and often overlap and how the contaminant, melamine, ended up in pet food and the feed supply for food production animals. Fortunately, we averted what could have been a problem for human food,” Dr. Dunham added. For this reason, she foresees close col-laborative efforts with CFSAN to coordinate food and feed protection across the Agency, which are pivotal to ensuring that future problems either do not arise or, if they do, are quickly resolved.

Risk communication

One of the key challenges Dr. Dunham sees for CVM is communicating the risk associated with products in a manner that is scientifically accurate yet easily understandable by people without a scientific background. This need was illus-trated so vividly by the pet food recall, which involved a massive public information effort and the interplay of so many dif-ferent FDA players. “Staff from CVM, the Agency’s Office of Regulatory Affairs, and the Office of Public Affairs among others worked 24-7 to answer phones, respond to e-mails, constantly update the Web site, and liaison with the affected companies in an effort to keep our messages consistent and to reassure the public,” Dr. Dunham said. “And the whole effort was very stressful, too, because peoples’ pets were involved; and as veterinarians, we are keenly sensitive to the importance of companion animals,” she added. She also mentioned the need to always continue fine-tuning our mes-sages to the public, because no matter how strong the effort, there is always room for improvement in this area.

Pet owners want the best treatment

Dr. Dunham noted that pet owners are increasingly demanding the best possible medical treatment for their pets, so the challenges CVM faces with respect to innovative product approvals and treatment modalities will spill over into the veterinarian profession as well. As more and more break-through medical products enter the marketplace, especially in such fields as biotechnology, pharmacogenomics, and oncology, veterinarians will also be directly involved in the chal-lenges of risk awareness and risk communication, Dr. Dunham explained. “We welcome partnering with the veterinary profession in this arena and assisting in any way we can,” she added.

The first woman to head CVM

FDA has had many women as Center Directors, but it is no secret that Dr. Dunham is the first woman to head CVM, and she views this as just another plus about the job. “I was only one of 15 women in my veterinary school class of 1982, and with this new opportunity unfolding before me, I hope to make the veterinary profession proud and to do it justice on behalf of all women,” she commented. Even though it may be a little premature to be talking about a legacy, Dr. Dunham said that she hopes to be able to look back one day and feel proud and assured that she was able to be part of the suste-nance and nurturing of CVM and advancing its important mission. “If I could do that, I would be floating,” she added. I have no doubts that Dr. Dunham will get her wish.