Animal & Veterinary
What Does the MUMS Legislation Mean?
by Jon Scheid, Editor, based on a conversation with Dr. Beaulieu and Dr. Oeller
FDA Veterinarian Newsletter July/August 2004 Volume XIX, No IV
Congress has approved and the President has signed the Minor Use and Minor Species Animal Health Act. This legislation adds new options for approving limited-use drugs and provides for a new mechanism to legally market some unapproved products. Here is a discussion of what these changes will mean. Andrew Beaulieu, D.V.M., is CVM’s Associate Director for Animal Health Policy and Operations, and Meg Oeller, D.V.M., a CVM specialist in the area of Minor Use and Minor Species (MUMS).
What defines a minor species?
Over the years, the Center for Veterinary Medicane (CVM) and the animal health industry have followed the definition of minor species in the Code of Federal Regulations. This defines minor species by exclusion, meaning that the major species have been identified, and all others are considered minor species. Major species are cattle, swine, chickens, turkeys, horses, dogs and cats.
Historically, a species was considered to be a major species if it had a large enough population to generate a significant market for animal health products. This new law adds the definitions of major and minor species as well as the definition of minor use to the statute.
Under the new law, the Secretary of Health and Human Services has the authority to write a regulation to change a species classification from minor to major, but not from major to minor.
What are the criteria for determining minor use?
Frequency and geography define minor use. Minor use means that the intended use of a drug in a major species is for an indication that occurs infrequently and in a small number of animals, or in a limited geographical area and in only a small number of animals annually.
Do veterinarians really treat minor species such as earthworms, crickets, honeybees or abalone?
Yes, they do. Also, these species may be treated when they are sick, but not always by a veterinarian. Many times the owners of the animals are forced to treat them themselves to prevent disease or death. Minor species are typically treated with drugs not approved for them, because no such approved drugs exist. Although the legislation will not make drugs available for all species and for all needs, it will offer new options for drug sponsors to start developing additional products that FDA could approve or otherwise make legally available for use by veterinarians and by laypersons to treat minor species.
Why should companies and the government expend resources on keeping minor species healthy?
The effects of MUMS can go well beyond the health of individual minor species animals. Keeping these animals healthy is important for the animal’s welfare, for the prevention of the spread of diseases to other animals or humans, and because these animals often provide other benefits to humans. The honeybee is a good example.
The U.S. Department of Agriculture estimates that the honeybee is responsible for 80 percent of all crop pollination in the United States. Major crops that depend on honeybees for pollination are alfalfa seed, almond, apple, avocado, blueberry, cantaloupe, cherry, cranberry, cucumber, honeydew, kiwi fruit, pear, plum, sunflower, vegetable seed and watermelon. The National Honey Board says that professional beekeepers keep about 2 million bee colonies moving from State to State every year providing pollination services. In other words, keeping the bee population healthy is essential to production of many of the crops we eat.
Will FDA play any role in determining whether research will be directed at specific minor species or uses?
Yes, but only indirectly. The new law includes a provision for making grants available for MUMS research. CVM will award grants to applicants doing research in these areas. Because it will decide how the grant money will be awarded, it will have some influence on what research will be done. However, the amount of funding available for the grant program is limited, so the overall influence will be limited.
How much will be available in grants? Who will be eligible to receive them? Who will decide who gets them?
For the first fiscal year (October 1 to September 30), the legislation authorizes $1 million for grants. The amount rises to $2 million the second year. But, even though MUMS authorizes the funds, Congress must also appropriate the funds before the grant program can be used. The first year’s grants cannot be awarded until implementing regulations are written, so there will be a delay of at least 12 months while proposed rules are drafted before the grant application process can actually begin.
What is the marketing exclusivity offered under the legislation? How will it help get drugs available?
For designated drugs, this provision gives the sponsor seven years exclusivity for a specific drug indication. That market protection can give a sponsor a strong incentive to bring a product in for review because the sponsor can sell that product without competition for seven years.
One of the MUMS mechanisms is the “conditional approval.” How much money will that save a sponsor? Will the large drug companies be able to take advantage of this provision?
It will not save sponsors much money in the total cost of the drug approval because they have to do everything that they would do for a regular FDA approval. The timing is what changes. It will allow the sponsor to begin generating revenue from the market for up to five years while completing the application process. Under this legislation, after a MUMS product has been shown to be safe, the company can market it while completing the effectiveness studies. CVM will continue to monitor the company’s progress and can require that the company stop marketing the product at any time if progress toward completion of the approval package is unsatisfactory, or if the product is found to be ineffective or unsafe. This conditional approval mechanism could benefit any company, large or small.
An outside panel will decide if sufficient safety and effectiveness data are available to place a drug on the Index, but who will decide which drugs to consider?
First of all, the Index is for products that would probably not be able to be approvable through the regular process. It is for zoo animals and exotic pets and other animals that are so varied (tropical fish), or rare (pandas), or valuable (macaws) that traditional controlled studies are just not feasible.
The potential sponsors will decide which drugs should be reviewed. It makes no sense to review drugs unless the sponsors are willing to bring them to the market. For such products, a sponsor first will ask FDA to determine whether the product is eligible for the indexing process. If so, then the sponsor can collect all pertinent information available on the product for review by a panel of experts deemed appropriate by the FDA. A report of the expert panel will be reviewed by FDA to determine whether a product may be included in the index, that is, whether it may be legally marketed without being fully approved.
Will MUMS mean that all zoo animals and others will have all the drugs they need? What do you think are the realistic limits to the effects of MUMS?
Again, the MUMS legislation was never meant to assure that all species will have all the drugs they could need. Instead, the legislation was meant to adjust or augment the approval process so that more drugs could become legally available for minor species or minor uses. The development and subsequent review of drugs for use in any species of animal is a complex, scientific undertaking that must be done in a way that complies with the law. MUMS changes the law for limited-use drugs in the hope that sponsors will be more willing and able to do the work needed to bring safe and effective drugs to the market. Other changes in legislation could help, too, as will improvements in science. The MUMS legislation is just one more improvement in the drug availability picture called for by the ADAA.