What is OMUMS?
What is the MUMS Act?
What is the purpose of OMUMS and the MUMS Act?
What are major species?
What are minor species?
What is a minor use in a major species?
What is a small number of animals for each major species?
Why is there a lack of MUMS drugs on the market?
Why is the MUMS Act important?
What are the key provisions of the MUMS Act?
What is conditional approval?
What is designation?
What is indexing?
Is the MUMS Act working?
How can I get more information?
Cow, chicken, cat, catfish – one of these animals is not like the others. Read more to find out which one and why it’s different.
OMUMS is short for “Office of Minor Use and Minor Species Animal Drug Development.” Established by the MUMS Act, OMUMS is the smallest office in the Food and Drug Administration’s Center for Veterinary Medicine.
The MUMS Act is short for “Minor Use and Minor Species Animal Health Act.” The MUMS Act was signed into law by President George W. Bush in 2004.
The purpose of OMUMS and the MUMS Act is to help make drugs available for minor species and for minor uses in a major species (“MUMS drugs”).
There are seven major species: horses, cattle, pigs, dogs, cats, chickens, and turkeys.
Minor species are all animals that are not major species. Examples of minor species are:
- zoo animals, such as lions and tigers;
- “pocket pets,” such as guinea pigs, gerbils, hamsters, and ferrets;
- laboratory rodents;
- fish; and
- pet birds, such as parrots and parakeets.
Some minor species are important to agriculture, including sheep, goats, catfish, llamas, bison, honey bees, and gamebirds such as pheasants.
Have you figured out which animal at the top isn’t like the others? If you said “Catfish,” you’re right! A catfish is a minor species, while a cow, chicken, and cat are all major species.
A minor use in a major species is the use of a drug in a major species for a condition that occurs:
- infrequently and in only a small number of animals each year; or
- in limited geographic areas and in only a small number of animals each year.
For example, the use of a drug to treat cancer in cats may be a minor use in a major species if only a small number of cats typically get that type of cancer each year.
OMUMS determined that “a small number” is less than:
- 50,000 Horses
- 70,000 Dogs
- 120,000 Cats
- 310,000 Cattle
- 1,450,000 Pigs
- 14,000,000 Turkeys
- 72,000,000 Chickens
Two main reasons explain the lack of MUMS drugs on the market. First, it is very expensive for a drug company to get a drug developed, approved by FDA, and on the market for sale. Second, the market for a MUMS drug is too small to generate an adequate financial return for the company. The combination of the expensive drug approval process and the small market makes most drug companies hesitant to spend a lot of resources to develop MUMS drugs when there is so little return on their investment.
The MUMS Act is important because it:
- provides for innovative ways to bring MUMS drugs to market faster; and
- helps drug companies overcome the financial roadblocks in developing drugs for the small MUMS market.
The MUMS Act amended the Federal Food, Drug, and Cosmetic Act by providing for three key provisions – conditional approval, designation, and indexing.
Conditional approval allows a drug company to legally market a MUMS drug before collecting all necessary effectiveness data, but after proving the drug is safe and likely to be effective. Conditional approval does not reduce the requirements for approval. It simply allows the drug company to market the drug while completing the effectiveness requirement. This early marketing is good for two reasons: first, the drug is available to the MUMS market; and second, the company can recoup some of the investment costs while pursuing a full approval.
At the time of conditional approval, the drug must meet all the requirements for approval except for effectiveness. The drug company can market the conditionally approved drug for up to five years, with annual renewals, while collecting the remaining effectiveness data. Once the remaining effectiveness data are collected, the drug company submits a request for full approval to the Office of New Animal Drug Evaluation.
Extra-label (“off label”) use of a conditionally approved drug is not allowed. There is also no marketing exclusivity for a conditionally approved drug (unless the drug is also designated). This means that if another drug company gets the same MUMS drug fully approved for the same use first, FDA will pull the conditionally approved drug off the market.
What does “extra-label” mean?
When an approved drug is used in a manner other than what is stated on the labeling, it is an extra-label use. This is commonly called an “off-label” use because the drug is used in a way that is “off the label.” It is illegal to use a conditionally approved drug or an indexed drug in an extra-label manner. Conditionally approved drugs and indexed drugs must be used exactly as stated on the labeling.
Designation provides drug companies with financial incentives, such as grants and exclusive marketing rights, to pursue an approval or conditional approval for a MUMS drug. A drug company submits a request to OMUMS to designate a drug for a specific use. After OMUMS grants the designation request, no other identical designation may be granted. However, OMUMS can grant more than one designation for the same drug, as long as the designations are for different uses or different dosage forms. OMUMS can also grant designations for different drugs for the same use.
Once a drug company gets a drug designated, the company or other organizations or individuals working with the company are eligible for grants through the federal government. This grant money is used to reduce the costs of conducting safety and effectiveness studies.
What does “dosage form” mean?
The dosage form is the drug’s physical form when it comes out of the manufacturing facility. There are several categories of dosage forms, including oral and injectable. A drug given by mouth is an oral dosage form. Tablets and capsules are two types of an oral dosage form. A drug that is injected under the skin, into muscle, or into a vein is an injectable dosage form. A solution is a common type of an injectable dosage form.
For purposes of designation, OMUMS considers all types of dosage forms within one category to be the same. Let’s say a drug company submits a request to OMUMS to designate a drug to treat liver flukes in llamas. The company makes the drug as both a capsule and a tablet. OMUMS would not grant one designation for the drug as a capsule and a second designation as a tablet. Rather, OMUMS would grant only one designation for the drug as an oral dosage form to treat liver flukes in llamas.
Designation requires that the drug company actively work toward approval and provide annual reports to OMUMS to show progress toward approval. A drug company that receives approval or conditional approval for a designated drug receives seven years of exclusive marketing rights, beginning on the day of the approval or conditional approval. This means other drug companies must wait seven years before they can get the same drug approved or conditionally approved by FDA for the same use.
Designation is a status that qualifies a drug company to receive financial incentives. It does not mean the drug is approved. It is illegal for a company to sell, promote, or advertise the designated drug until it is approved or conditionally approved.
Designation can be terminated if another drug company gets the same drug approved or conditionally approved for the same use before the designated drug. It can also be terminated for other reasons, including lack of progress toward approval.
Indexing allows the legal marketing of unapproved animal drugs for use in certain minor species as long as the drugs are on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Simply referred to as “the Index,” it is a list of drugs that used an alternative pathway to get on the market.
In some cases, a drug intended for a minor species cannot reasonably go through the standard drug approval process. For example, an animal may be too rare or valuable, such as the endangered California condor, or the animals may be too varied, such as ornamental fish, to be used in traditional safety and effectiveness studies to support approval. In these instances, indexing provides an alternative pathway to get a drug on the market.
Indexing is allowed for drugs for:
- Non-food-producing minor species, such as pet birds, hamsters, and ornamental fish. These animals do not produce food for people to eat; and
- Early life stages of a food-producing minor species, such as oyster spat (immature oysters). Because people do not generally eat oyster spat, a drug to treat a disease in spat can be indexed, but a drug to treat a disease in adult oysters, which people commonly eat, cannot be indexed.
Extra-label use of an indexed drug is not allowed, and there is no marketing exclusivity for indexed drugs.
An indexed drug cannot compete with an approved drug, meaning that a drug cannot be listed on the Index if the same drug is already approved for the same use. However, indexed drugs can compete with each other, meaning that two drug companies can have the same drug listed on the Index for the same use.
A drug company has to go through a three-step process to get a drug listed on the Index:
- The company submits a request to OMUMS to determine the eligibility of the drug for indexing. In the request, the company must provide information showing the drug does not pose any safety concerns to the end user (the person giving the drug to the animal) or to the environment. The company must also explain the manufacturing process for making the drug. Based on the information in the request, OMUMS decides if the drug is eligible for indexing.
- The company chooses qualified experts outside of FDA to serve on a panel. OMUMS must agree with the experts chosen by the company. The panel reviews information on the safety of the drug to the animal and the drug’s effectiveness when it is used according to the proposed label.
- The outside expert panel submits a report of its findings to OMUMS. All members of the expert panel must agree that the drug is safe and effective when it is used according to the proposed label. If OMUMS agrees with the panel’s report, the drug is added to the Index.
Unlike the long removal process for an approved drug, an indexed drug can be quickly removed from the Index and pulled off the market if problems arise. And unlike conditional approval and designation, indexing does not require the drug company to be actively working toward approval.
Yes! FDA’s Center for Veterinary Medicine (CVM) has conditionally approved two drugs, one to treat a bacterial disease in catfish and one to treat a type of skin cancer in dogs. OMUMS has also granted over 90 designations. Two drugs are already on the Index, with more in the process of being indexed. CVM is working hard to make sure safe and effective drugs are available for minor species and for minor uses in a major species.
- Contact FDA’s Center for Veterinary Medicine at 240-276-9300 or AskCVM@fda.hhs.gov
- Visit CVM’s Minor Use/Minor Species Web page at http://www.fda.gov/AnimalVeterinary/