FDA to Retain Current Small Numbers of Animals for Minor Use in Major Species

The U.S. Food and Drug Administration (FDA) announced on May 19 that, following a reassessment, it will continue using the same “small numbers of animals” in a major species to determine whether an intended use of a new animal drug in a major species of animal qualifies as a minor use.

The Minor Use and Minor Species Animal Health Act (MUMS Act) provides incentives for animal drug development and approval to be used in minor animal species and for minor uses (e.g., uncommon diseases) in major animal species. FDA established, and periodically reassesses, a specific “small number of animals” for each of the seven major animal species to be used in determining whether any particular intended use in a major species qualifies as a minor use. Major species of animals include dogs, cats, horses, cattle, pigs, turkeys and chickens.

The FDA established the small numbers rule on Aug. 26, 2009. The reevaluation takes into account increases in the cost of developing new animal drugs, increases in the amount of money animal owners will spend to treat an affected animal, and changes in the total population of major animal species, among other factors.

The FDA has determined that the currently established small numbers of major animals continue to be appropriate thresholds for minor use. These current numbers are:

  • 70,000 dogs
  • 120,000 cats
  • 50,000 horses
  • 310,000 cattle
  • 1,450,000 pigs
  • 14,000,000 turkeys
  • 72,000,000 chickens
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