August 3, 2004
New Legislation To Help Make Animal Drugs Available For Limited Uses, Minor Species
President Bush signed legislation on August 2, 2004 , that will help make more medications legally available to veterinarians and animal owners to treat minor animal species and also u nc ommon diseases in the major animal species.
This legislation provides innovative ways to bring such products to market and is designed to help pharmaceutical companies overcome the fina nc ial roadblocks they face in providing limited-demand animal drugs.
The animal drugs measure is expected to benefit people who own small or unusual pets such as guinea pigs or ornamental fish, and it will likely be a great help to zoo veterinarians. Before this legislation , pharmaceutical companies could rarely afford to bring to market drugs for novel pets and zoo animals , because t he markets were too small to generate an adequate fina nc ial return.
The new law, officially named “The Minor Use and Minor Species Animal Health Act of 2004,” dubbed “MUMS” for Minor Use/Minor Species, provides some flexibility in getting limited-use drugs to market.
Minor use drugs are d rugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that have a limited geographic range or affect a small number of animals. Minor species are all animals other than the major species, which i nc ludes zoo animals , ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importa nc e are also minor species. These i nc lude sheep, goats, catfish, and honeybees.
The new law will modify provisions of the Federal Food, Drug and Cosmetic Act in three key ways.
Conditional Approval: Under MUMS, the sponsor of a veterinary drug can ask CVM for “conditional approval,” which allows the sponsor to make the drug available before collecting all necessary effectiveness data, but after proving the drug is safe. The drug sponsor can keep the product on the market for up to five years, through annual renewals, while collecting the required effectiveness data.
Indexing: In some cases, the potential market for a minor species drug is just too small to ever support the costs of the drug approval process, even under a conditional approval. In such cases, FDA now may add the drug to an index of legally marketed unapproved new animal drugs. This provision will be especially helpful to veterinarians treating zoo or endangered animals or classes of animals that i nc lude several different species, such as ornamental fish.
Designation: This aspect of the legislation is similar to the “Orphan Drug Act” for humans, which helps pharmaceutical firms develop drugs for limited human uses. It provides i nc entives for approval. Grants to support safety and effectiveness testing will be available. Companies who gain approval for designated new animal drugs will be granted seven years of marketing exclusivity, which means the sponsor will face no competition in the marketplace for that use of the drug for that time.
Dr. Linda Tollefson, Deputy Director of FDA's Center for Veterinary Medicine said, “This is an excellent law that will help veterinarians better serve zoo animals, endangered species and many other minor species.”
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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