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Lions and Tigers and Bears! OMUMS!

 


 

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?
Is conditional approval only for MUMS drugs?
Which office in FDA's Center for Veterinary Medicine oversees 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.

What is OMUMS?

OMUMS is short for “Office of Minor Use and Minor Species Animal Drug Development.” The office is the smallest in FDA’s Center for Veterinary Medicine and was formed as part of the MUMS Act.

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What is the MUMS Act?

The MUMS Act is short for “Minor Use and Minor Species Animal Health Act.” President George W. Bush signed the MUMS Act into law in 2004.

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What is the purpose of OMUMS and the MUMS Act?

The purpose of OMUMS and the MUMS Act is to help make more drugs available for minor species and for minor uses in a major species (“MUMS drugs”). 

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What are major species?

There are seven major species:  horses, cattle, pigs, dogs, cats, chickens, and turkeys. 

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What are minor species?

Minor species are all the animals, other than people, that are not major species. Examples of minor species are:

  • zoo animals and wildlife, such as lions and tigers and bears;
  • “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 and goats,
  • catfish and salmon,
  • emus,
  • 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. 

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What is a minor use in a 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 control pain in dogs with bone cancer is a minor use in a major species because fewer than 70,000 dogs typically get bone cancer each year.

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What is a small number of animals for each major species?

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

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Why is there a lack of MUMS drugs on the market?

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.  

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Why is the MUMS Act important?

The MUMS Act is important because it:

  • provides for innovative ways to bring MUMS drugs to the market faster; and
  • helps drug companies overcome the financial roadblocks in developing MUMS drugs for such a small market.

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What are the key provisions of the MUMS Act?

The MUMS Act amended the Federal Food, Drug, and Cosmetic Act by providing for three key provisions – conditional approval, designation, and indexing – to encourage drug companies to develop more drugs for small populations of animals and species that have few drugs approved for them.

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What is conditional approval?

Conditional approval allows a drug company to legally sell 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 legally sell the drug for a limited period while completing the effectiveness requirement. This early marketing is good for two reasons: first, the drug is available sooner to be used in animals that may benefit from it; and second, the company can begin to recoup some of the investment costs while completing the full approval.

The initial conditional approval is valid for one year with the potential for four annual renewals. To receive a renewal from FDA, the company must show active progress toward completing the effectiveness requirement. After the drug company collects the remaining effectiveness data and applies for full approval, FDA reviews the data and, if appropriate, fully approves the drug.

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 withdraw the conditional approval. Only the fully approved drug is allowed on the market.

What does “extra-label” mean?

When an approved drug is used in a way that isn't listed 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.

Is conditional approval only for MUMS drugs?

No, in 2018, FDA expanded the availability of conditional approval to include non-MUMS drugs. Expanded conditional approval is for animal drugs intended for use in one of the seven major species that address:

  • a serious or life-threatening condition, but demonstrating effectiveness would require complex or particularly difficult studies; or
  • an unmet animal or human health need, but demonstrating effectiveness would require complex or particularly difficult studies.

Similar to conditional approval for MUMS drugs, the goal of expanded conditional approval is to encourage drug companies to develop drugs for major species for serious or life-threatening conditions and to fill treatment gaps where no therapies currently exist or the available therapies are inadequate. FDA has a guidance document that explains the eligibility criteria for expanded conditional approval.

Which office in FDA’s Center for Veterinary Medicine oversees conditional approval?

The Office of New Animal Drug Evaluation (ONADE) oversees the conditional approval of any animal drug. However, if the drug is for a minor use in a major species, ONADE asks OMUMS to determine if the drug is eligible for conditional approval—that is, if the drug’s intended use is indeed a minor use in a major species. For example, if the drug is to treat a specific cancer in cats, it’s eligible for conditional approval only if OMUMS determines that less than 120,000 cats develop that type of cancer each year.

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What is designation?

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 to support the drug’s approval.

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.

OMUMS will terminate the designation if another company gets the same drug approved or conditionally approved for the same use before the designated drug is approved or conditionally approved. OMUMS can also terminate the designation for other reasons, including lack of progress toward approval.

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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 types of dosage forms, including oral and injectable. A drug given by mouth is an oral dosage form. Tablets and capsules are two variations 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 injectable dosage form.

For purposes of designation, OMUMS considers all variations within one type of dosage form 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 for the drug as a tablet. Rather, OMUMS would grant only one designation for the drug as an oral dosage form to treat liver flukes in llamas.

What is indexing?

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 legally reach 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 legally.

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 may not compete with an approved drug, meaning that a drug cannot be listed on the Index if the same drug made by a different company 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:

  1. The company submits a request to OMUMS to determine if the drug is eligible 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.
  2. The company chooses qualified experts to serve on a panel. The experts cannot be FDA employees and OMUMS must agree with who the company selects to be on the expert panel. The panel reviews information about the drug's safety and effectiveness when it is used according to the proposed label.
  3. The company submits a report of the expert panel's 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.

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Is the MUMS Act working?

Yes! FDA has conditionally approved several drugs, granted many designations, and indexed a number of drugs. FDA is working hard to make sure safe and effective drugs are available for minor species and for minor uses in a major species. The current Designations List and Index of Legally Marketed Unapproved New Animal Drugs for Minor Species can be found on FDA’s website.

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How can I get more information?

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