Animal & Veterinary
Dr. Dunham Is New OMUMS Director at CVM
FDA Veterinarian Newsletter 2006 Volume XXI, No III
Dr. Bernadette Dunham is the new Director of the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) at the Center for Veterinary Medicine (CVM). She succeeds Dr. Andrew Beaulieu, who will be retiring in early January 2007.
Dr. Dunham previously served as Deputy Director in CVM’s Office of New Animal Drug Evaluation. Immediately before coming to CVM in December 2002, Dr. Dunham was acting director of the American Veterinary Medical Association’s Government Relations Division in Washington, DC. In that position, Dr. Dunham represented the Association in a coalition of veterinary and animal drug industry groups that championed the MUMS legislation in Congress. She is a strong supporter of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).
Dr. Dunham has an extensive background in both human and animal medicine. She received her Doctor of Veterinary Medicine degree from Ontario Veterinary College, University of Guelph, Ontario, Canada. She has a Ph.D. in cardiovascular physiology from Boston University. She has worked as a practicing veterinarian in Canada. She also has been a research associate at Harvard Medical School, Boston, MA, and research assistant professor at Boston University.
She also served as the Director of Laboratory Animal Medicine and an Adjunct Professor of Pharmacology at the State University of New York Health Science Center, Syracuse, NY. Her research focused on the molecular regulation of cardiac gap junction proteins.
In addition, Dr. Dunham is an Adjunct Professor with the Department of Biomedical Sciences and Pathobiology at the Virginia-Maryland Regional College of Veterinary Medicine in Blacksburg, VA. She lectures on a variety of topics from emerging issues and opportunities in veterinary medicine to the role of consensus building in policy development.
In an interview with FDA Veterinarian, Dr. Dunham said the MUMS Act will help veterinarians as they treat many types of pets, wildlife, and zoo animals, as well as minor species food-producing animals. “Veterinarians want drugs available that they know are safe to use. They want to know the indications and the dosages that are appropriate to use,” she said. With so few approved drugs currently available for minor species, or for limited uses in major species, veterinarians often do not have legal access to the drugs they know will work. The MUMS Act and the provisions that CVM is implementing under its authority should go a long way to addressing that problem, she added.
Dr. Beaulieu and Dr. Meg Oeller of OMUMS, along with Dr. Jeff Punderson of CVM’s Policy and Regulations Staff, have already done a great deal of work to develop and implement the MUMS Act regulations, Dr. Dunham said. The next phase, which she will be most involved with, will be the finalization of the new regulations and execution of the new programs.
Dr. Dunham stated that Dr. Beaulieu is truly an icon at CVM, and he will be leaving some very large shoes for her to step into. “Having an opportunity to work directly with Dr. Beaulieu during the next few months before he retires will be an incredibly rewarding experience,” she said.
She is grateful for the wonderful support she has received from everyone at CVM and she is looking forward to the exciting work that the OMUMS will be embracing.
[Sidebar to article:]
Office of Minor Use and Minor Species Animal Drug Development
The Center for Veterinary Medicine’s (CVM) Office of Minor Use and Minor Species Animal Drug Development (OMUMS) was authorized under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). The office has the responsibility at CVM for implementing the provisions of the MUMS Act, which are designed to encourage the development and legal marketing of drugs for minor species and minor uses.
Minor species are any species except the major species, which are cattle, swine, chickens, turkeys, horses, dogs, and cats. Minor use drugs are for major species, for infrequent use and use in a limited number of animals. These markets have been underserved because drug sponsors are unwilling or unable to seek approvals for such products due to the limited return on investment.
Congress drafted the MUMS Act to provide incentives for drug companies to develop products for these underserved markets. The three major incentives of the MUMS Act are
- Designation, which gives new MUMS products extended periods of market exclusivity and makes them eligible for grants and contracts
- Conditional approval, which allows companies to market products for up to five years, after demonstrating safety and a reasonable expectation of effectiveness, while working to confirm effectiveness and achieve full approval; and
- Indexing, which permits the legal marketing of unapproved new animal drugs for minor species following the Food and Drug Administration’s (FDA) acceptance of recommendations from external expert panels.
In addition to implementing the provisions of the MUMS Act, OMUMS is also responsible for liaison work with the U.S. Department of Agriculture’s minor species research program, NRSP-7, and serves as FDA’s resource for policy questions regarding minor use and minor species.