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U.S. Department of Health and Human Services

Animal & Veterinary

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by Karen A. Kandra
FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

The Center for Veterinary Medicine (CVM) is pleased to announce that FDA Commissioner Jane E. Henney, M.D. has approved the appointment of Dr. Andrew J. Beaulieu as Deputy Director, succeeding Dr. Michael J. Blackwell, who left CVM on February 1, 1999.

A native of Washington, D.C., Dr. Beaulieu holds both a B.S. and B.A. degree from the University of Miami, and received his D.V.M. degree cum laude from The Ohio State University. Dr. Beaulieu credits a "back-fence" neighbor, who was an FDA chemist, with planting the FDA seed "way back" when he was in Junior High School, and some very effective cultivation by Dr. Homer Smith, former Regional Veterinary Medical Officer in the Cincinnati District Office with influencing him to apply to the Food and Drug Administration during his senior year at Ohio State. Both gentlemen spoke very convincingly of FDA's underlying "moral purpose", resulting in Dr. Beaulieu's ultimate decision to dedicate his entire career to CVM, beginning as a veterinary reviewer in the Office of New Animal Drug Evaluation (ONADE) in June, 1972. In 1974, Dr. Beaulieu transferred to the Office of Surveillance and Compliance (OSC), where he moved up to Division Director in the Division of Surveillance until 1991, when he became Director of the Division of Therapeutic Drugs for Food Animals in ONADE. In November, 1992, he was appointed a Deputy Director of ONADE. In addition, Dr. Beaulieu also served in the Office of Research for a brief time.

It is Dr. Beaulieu's belief that a regulatory organization's decision-making is greatly influenced by regulatory and judicial precedents, and that institutional knowledge has an impact on virtually everything that is done in such an organization. CVM Director, Dr. Stephen Sundlof says, "There are few if any who command Dr. Beaulieu's historical knowledge of and broad experience within CVM. His recent efforts to re-engineer the new animal drug approval process and his experience with the implementation of the Animal Drug Availability Act (ADAA) will bring valuable perspective to his new job."

During his 27-year CVM tenure, Dr. Beaulieu has provided outstanding leadership in the direction and oversight of many of the Center's activities. He was directly involved in promoting and implementing the "phased-review" process, which provides for mapping out the drug development process between the sponsor and CVM personnel, and permits different parts of the process to proceed simultaneously on different time tracks, shortening the overall drug development and review process. Over the last few years, he has also been responsible for managing to near completion the process of DESI-finalization, an effort that has been ongoing within CVM for more than 20 years. In the past, Dr. Beaulieu served as one of five Project Management System (PMS) managers in CVM, overseeing the planning, allocation, and utilization of resources throughout the Center. More recently, he played a very active role in negotiating the changes represented by the ADAA, and has helped draft interpretive policy and regulations to implement the statutory changes.

In a time of shrinking resources, many challenges are presented for CVM's management team. Dr. Beaulieu hopes to continue working on the New Animal Drug procedural regulations, a long-term project to improve the animal drug approval process, as well as to continue to work toward developing innovative ways to provide for the legal marketing of drugs for minor species. In addition, he has a long-standing commitment to participatory management and team decision-making, which CVM is fostering through its ongoing High Performance Organization (HPO) initiative.

Dr. Beaulieu has been honored with two Awards of Merit, four Commendable Service Awards, a Commissioner's Special Citation, a Deputy Commissioner's Special Recognition Award, and numerous Group Recognition Awards during his distinguished FDA career.

Dr. Beaulieu has effectively represented the Center's interests at the national and international level. His thorough working knowledge of the animal product-related provisions, limitations and practical applications of the Food, Drug, and Cosmetic Act makes Dr. Beaulieu uniquely qualified and a valuable addition to CVM's leadership team.

An avid golfer, Dr. Beaulieu resides in Silver Spring, Maryland with his wife, Julie, and daughters, Elyse and Kathryn, both college students. We wish him the best of luck as he assumes this very deserved role in CVM.