More options expected for treating rare conditions in dogs and cats

The Food and Drug Administration plans to change its rules for approving the status of minor use for animal drugs, a move the agency anticipates will make new treatment options available for rare diseases and conditions in dogs and cats.

The FDA Center for Veterinary Medicine announced plans to increase the maximum numbers of dogs and cats that can be affected by a disease or condition in order for a treatment to qualify as a minor use. The agency is accepting public comment on the change through Nov. 14 and expects the change to take effect Dec. 14.

Animal drugs that meet the definition of a minor use qualify for designation by the FDA as such a drug, conditional approval, and waivers from user fees. Designated drugs are eligible to receive exclusive marketing rights and grants to support product development and approval. Conditional approval allows quicker access to the marketplace and also allows patient access to safe medications that are reasonably expected to be effective while full effectiveness data is being collected.

To qualify for status as a minor use, a new animal drug must be intended to treat a disease or condition that meets all of the following requirements:

• Affects what the FDA considers a major species: dogs, cats, horses, cattle, swine, chickens, or turkeys.
• Occurs infrequently or in limited geographic areas.
• Occurs in fewer than a small number of animals annually.

The new rule would increase the threshold of small numbers that helps an animal drug qualify for status as a minor use. For cats, the new threshold would increase to 150,000 cases per year, up from 120,000. For dogs, the threshold number would increase to 80,000 cases per year, up from 70,000.

For more details and instructions to submit public comment, see the agency’s announcement in the Federal Register.