Animal & Veterinary
New “MUMS” Legislation to Help Make Animal Drugs Available for Limited Uses, Minor Species
by Meg Oeller, DVM, and Jon Scheid, Editor
FDA Veterinarian Newsletter July/August 2004 Volume XIX, No IV
President Bush has signed legislation that will help make more medications legally available to veterinarians and animal owners to treat minor animal species and also uncommon diseases in the major animal species.
This legislation provides innovative ways to bring such products to market and helps pharmaceutical companies overcome the financial roadblock they face in providing limited-demand animal drugs, according to supporters.
Congress completed work on the measure July 20, and the President signed it on August 2. It was part of a legislative package that also included a food allergen labeling law.
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, supporters said. Before this, pharmaceutical companies could rarely afford to bring to market drugs for novel pets and zoo animals. The markets were just too small to generate an adequate financial return.
The standards for drug approval are those established by the Federal Food, Drug and Cosmetic Act, which is the legal authority the Food and Drug Administration (FDA) uses to approve animal drugs. Generating those data to meet these standards is an expensive process.
Animal drug companies can make more money by developing drugs that have broad uses, such as treating some of the 95 million cattle or 60 million hogs in the United States. The financial returns from these markets are much more likely to repay the costs of developing the drugs.
The goal of this legislation is to provide incentives to pharmaceutical companies to develop drugs for limited uses and to provide some alternative approaches to the usual drug approval process for limited-use animal drugs, thus changing the economic outlook for the drug approval process.
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 drugs 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 includes all animals other than the major species, which includes zoo animals, ornamental fish, parrots, ferrets and guinea pigs. Some animals of agricultural importance are also minor species. These include sheep, goats, catfish and honeybees.
The Center for Veterinary Medicine (CVM) was charged to develop policies, regulations or legislative options to facilitate drug availability for MUMS by a provision of “The Animal Drug Availability Act” of 1996.
After CVM published a report containing the initial concepts for MUMS, a coalition of animal drug sponsors and other affected parties began the process of talking to Congress about the legislation.
The new law will modify provisions of the Federal Food, Drug and Cosmetic Act in three ways.
Conditional Approval: An expensive part of the drug approval process for companies is demonstrating that a drug is effective. Drug companies typically collect data from various clinical trials. 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. The revenue the product generates during this period will help the company defray the cost of collecting the data. After the sponsor has completed the effectiveness component, the sponsor can present that component to CVM for full approval of the product.
Under MUMS, FDA may refuse to renew the conditional approval if the company is not making sufficient progress toward collecting the 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. The population may not be suitable for use in clinical studies because the animals are rare or valuable. In such cases, FDA now may add the drug to an index of legally marketed unapproved new animal drugs.
After FDA determines that a drug could be eligible for listing on the index, the drug sponsor will use outside experts to review all of a drug’s available safety and effectiveness information. The panel will provide a report to FDA/CVM of its findings so that the Agency may determine whether the drug should be placed on the index list.
This provision will be especially helpful to veterinarians treating zoo or endangered animals or classes of animals that include several different species, such as ornamental fish.
This provision will not be used for food animals with the exception of some early life stage uses, such as fish eggs. This provision would apply only to drugs for minor species, and not to minor uses of drugs in major species.
- 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 incentives 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.
The new law authorizes CVM to establish an office of Minor Use and Minor Species Animal Drug Development, which will be responsible for designating minor use and minor species animal drugs, administering grants, reviewing minor species drug index listing requests and serving as liaison to all parties involved with minor use or minor species drug development.