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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Recognizes Industry Expert for MUMS Legislative Push

by Richard L. Arkin, Assistant Editor
FDA Veterinarian Newsletter May/June 2005 Volume XX, No III

Dr. John R. “Randy” MacMillan, an industry fisheries specialist, was awarded the Food and Drug Administration (FDA) Commissioner’s Special Citation in a ceremony May 6 for his work in supporting animal drug availability and in leading the coalition that was instrumental in securing passage last year of the Minor Use and Minor Species (MUMS) Animal Health Act.

Dr. MacMillan, Vice President for Research and Environmental Affairs, Clear Springs Foods, Inc., Buhl, ID, was presented the award at the FDA Honor Awards Ceremony in Gaithersburg, MD, by FDA Commissioner Dr. Lester M. Crawford and Center for Veterinary Medicine (CVM) Director Dr. Stephen F. Sundlof.

The award cited Dr. MacMillan “for outstanding effort and perseverance in support of animal drug availability culminating in passage of the Minor Use and Minor Species Animal Health Act of 2004.”

The MUMS Animal Health Act is intended to be a mechanism to provide FDA-authorized drugs for use in “minor” species and to provide common food and companion animal or “major” species with needed therapeutics for uncommon indications or “minor uses.” The major species are cats, dogs, horses, cattle, swine, turkeys, and chickens. Minor species are all other animals, including sheep, goats, game birds, emus, ranched deer, alpacas, llamas, deer, elk, rabbits, guinea pigs, pet birds, reptiles, ornamental and other fish, shellfish, wildlife, zoo and aquarium animals.

“After all, it is a truism that minor uses and minor species are, well, minor,” Dr. MacMillan explained. “There are seven major animal species, meaning that all the rest are minor,” he added, “including, for example, the 35 species of fish raised for food and more than 800 ornamental fish species commonly in distribution.”

Dr. MacMillan said that an industry-wide effort was necessary to deal with legislative solutions. “Industry, zoos, and others interested in increasing drug availability for minor uses and minor species needed a broad coalition to draft the legislation and do the legwork necessary to get it passed,” he explained.

“We were a bit naïve at first,” Dr. MacMillan later commented. “We thought the need was so clear and that our legislative initiatives were so simple and straightforward that Congress would agree right away. It turned out that a multi-year, sustained effort was necessary to educate Congress and the public.”

Dr. MacMillan chaired the MUMS Coalition, an organization formed to support the MUMS legislation, which was made up of animal health industry organizations and representatives from across the industry. A diverse group of veterinarians, animal owners and -producers, and developers of animal products, the MUMS Coalition’s 43 member organizations represent those involved in the care of terrestrial, aquatic, domestic, and wild animals, those kept as pets, livestock, zoological and aquarium collections. Members of the MUMS Coalition include the American Veterinary Medical Association, American Farm Bureau Federation, Animal Health Institute, American Pet Product Manufacturers Association, American Feed Industry Association, and National Aquaculture Association.

Dr. MacMillan called the group “a broad-based” coalition that worked with other interest groups and CVM over a six-year period to provide technical assistance, education, and other support to Congress in drafting and passing MUMS legislation. The process of drafting and ultimately passing particularly novel drug legislation is often quite long and arduous, and that was especially true for MUMS legislation, in part because of the difficulty of meshing complicated science and policy issues, and in part because of the complexity of the legislative process, he said.

The dedication and perseverance of Dr. MacMillan and other members of the coalition paid off when MUMS Animal Health Act became law last year, creating a climate that will ultimately lead to an increase in the number of approved animal drugs for species and ailments for which treatment options have traditionally been limited.

As the Senate report accompanying the MUMS Animal Health Act stated, the legislation was necessary because of a severe shortage of approved new animal drugs for use in minor species and for treating animal diseases and conditions that occur infrequently or in limited geographic areas. Because of the small market shares for these products, low-profit margins involved, and capital investment required, it has generally not been economically feasible for new animal drug applicants to pursue approvals for drugs to treat these species, diseases, and conditions. Additionally, because the populations for which such new animal drugs are intended may be small and conditions of animal management may vary widely, it has often been difficult to design and conduct studies to establish drug safety and effectiveness under traditional new animal drug approval processes, the report said.

In passing the MUMS Act, Congress decided that the public interest and the interest of animal welfare required the provision of special procedures to allow the lawful use and marketing of certain new animal drugs for minor species and minor uses that take into account these special circumstances and that ensure that such drugs do not endanger animal or public health, the Senate report said.

Legislation

To address these issues, the legislation provided for:

  • Creation of a conditional approval mechanism for new animal drugs for minor uses and minor species that allows for early marketing while effectiveness studies are completed;
  • Formulation of an index of legally marketed unapproved new animal drugs for non-food minor species and non-food life stages of food-producing minor species under limited circumstances; and
  • Initiation of a process for classifying certain new animal drugs for minor uses and minor species as “designated” new animal drugs to qualify them for incentives, including grants and exclusive marketing rights, to help compensate drug sponsors for clinical testing expenses to encourage them to develop new MUMS animal drugs.

The legislation maintains all pre-existing FDA requirements for the approval of animal drugs including antimicrobials, however. Only indexed drugs will be made available under a different standard.

The MUMS Animal Health Act also provided for the organization of a new Office of Minor Use and Minor Species Animal Drug Development within CVM. This Office is responsible for designating minor use and minor species animal drugs, for administering grants and contracts, for reviewing minor species drug index listing requests, and for serving as liaison to other government agencies interested in minor use and minor species animal drug development. The legislation also requires FDA to issue proposed and final regulations and establish deadlines for these to be published.

Some provisions of the new law went into effect immediately after the bill was signed. These include conditional approval and designation. Indexing cannot be implemented until the publication of the final regulations, due in August of 2007.

“Team effort”

Dr. MacMillan called the push to pass the MUMS legislation “a team effort.” He added: “In my view, getting the MUMS bill passed took the combined efforts of FDA, CVM, and the entire MUMS Coalition,” Dr. -MacMillan stated. “It was a great team effort, and we all stuck together,” he said. “Now that the legislation is law, we’re looking for continuing collaboration -because we still have a long way to go” in making therapeutic drugs available for minor uses and minor species, Dr. -MacMillan added.

Dr. MacMillan has been Clear Springs Foods’ Vice President of Research and Environmental Affairs since 1998. In that role, he is responsible for the company’s research and development, environmental stewardship of natural resources, and quality assurance programs. In addition to the MUMS coalition, which he continues to lead, Dr. -MacMillan is president of the National Aquaculture Association and was chair of the joint National Association of State Aquaculture Coordinators-National Aquaculture Association Committee on National Aquatic Animal Health Management Plan Development. He is also Chairman of the Idaho Board of Environmental Quality and immediate Past Chairman of the Upper Snake River Basin Advisory Group.

Before assuming his current post at Clear Springs Foods, Dr. MacMillan served as that company’s Director of Research. Previously, he was an Associate Professor at Mississippi State College of Veterinary Medicine, an extension fisheries specialist in Mississippi, a research biologist for the U.S. Fish and Wildlife Service in Seattle, WA, and a Senior Research Fellow at the University of Washington School of Medicine.

Dr. MacMillan received his Ph.D. from the University of Washington in 1980. He also holds a Master of Science degree from Michigan State University and a Bachelor of Science degree from the University of Maryland.