FDA has an excellent information sheet about the issue of minor use of pharmaceuticals in major species (cats are considered a major species) and also minor species (rabbits and rats included here).
I think fair use allows me to post entire government documents here if they are for public release, so here it is:
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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 shorthand for “Office of Minor Use and Minor Species Animal Drug Development.”
OMUMS is the smallest Office in the Food and Drug Administration’s Center for Veterinary
Medicine (CVM). It was established by the MUMS Act.
What is the MUMS Act?
The MUMS Act is shorthand for “Minor Use and Minor Species Animal Health Act.” The MUMS
Act was signed into law by President George W. Bush in 2004.
What is the purpose of OMUMS and the MUMS Act?
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”).
What are major species?
There are seven major species: horses, cattle, pigs, dogs, cats, chickens, and turkeys.
What are minor species?
Minor species are all animals that are not major species. 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, are examples of minor species. Some minor species
are important to agriculture, including sheep, goats, catfish, llamas, bison, honey bees, and game
birds 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.
Animal Health Literacy
http://www.fda.gov/AnimalVeterinary 11/18/2009 2
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 occurs 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 get that type of
cancer each year.
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
Why is there a lack of available MUMS drugs on the market?
Two main reasons explain the lack of available MUMS drugs on the market. First, it is very expensive
for a drug company to get a drug developed, approved by the 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 substantial resources to develop a MUMS drug
when there is so little return on their investment.
Why is the MUMS Act important?
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.
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.
What is conditional approval?
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 there is a reasonable expectation
of effectiveness. 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.
http://www.fda.gov/AnimalVeterinary 11/18/2009 3
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 this remaining
effectiveness data is 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 its MUMS drug fully approved for the same use first,
the conditionally approved drug is pulled off the market.
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 for a drug to be designated for a specific use. After the designation
request is granted, no other identical designation may be granted. However, more than
one designation can be granted for the same drug, as long as the designations are for different
uses.
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.
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 the company will have no competition from other companies in the
marketplace for seven years.
Designation is a status that qualifies a drug company to receive financial incentives. It does not
mean that the drug is approved. It is illegal for a company to sell, promote, or advertize 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.
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 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
What does “extra-label” mean?
When an approved drug is used in a manner
other than what is stated on the approved labeling,
it is an extra-label use. This is commonly
referred to as an “off-label” use because the
drug is used in a manner 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.
http://www.fda.gov/AnimalVeterinary 11/18/2009 4
provides an alternative pathway to get a drug on the market that is faster than going through the
standard drug approval process.
Indexing is only available for drugs intended for a non-food producing minor species or for an early
life stage of a food producing minor species. Spat, or immature oysters, are an example of an
early life stage of a food producing minor species. Because people do not generally eat oyster
spat, a drug intended 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.
Drugs intended for transgenic animals 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. 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. First,
the company submits a request to OMUMS to determine the eligibility of the product for indexing.
To be eligible, a drug must 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. Second, the company chooses qualified experts outside of the FDA
to serve on a panel. OMUMS must agree with the experts chosen by the company. It is the
panel’s job to review information on the safety of the drug to the animal and the drug’s effectiveness
when it is used according to the proposed label. Third, the outside expert panel submits a
report of their 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.
Is the MUMS Act working?
Yes! One drug for use in catfish has been conditionally approved, and OMUMS has granted over
80 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.
How can I get more information?
Contact the FDA’s Center for Veterinary Medicine at 240-276-9300 or CVMHomeP@cvm.fda.gov
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If the format is hinky, don't blame me. I'm just the cut-and-paste lady.
