On July 26, the FDA published the final rule on designation of new animal drugs for minor uses or minor species. This means that drugs intended to help uncommon diseases or conditions in horses (which are considered major species) could get through the federal approval process easier and quicker, while making sure the  animals, and humans, are protected.

Congress recognized that the markets for drugs intended to treat minor species, diseases, or conditions are often so small that there are insufficient economic incentives to motivate sponsors to develop data to support approvals. As a result of these limitations, drug manufacturers have generally not been willing or able to collect data to support legal marketing of drugs for these minor species, diseases, or conditions.

Consequently, Congress enacted the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act), which amended the Federal Food, Drug, and Cosmetic Act to provide incentives to develop new animal drugs for minor species and minor uses, while still ensuring appropriate safeguards for animal and human health.

The MUMS act, among other things, created section 573 to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. This act parallels similar legislation passed under the Orphan Drug Act https://www.fda.gov/orphan/oda.htm for humans. FDA published a proposed rule in the Federal Register of Dec. 28, 2005, to implement these new procedures. FDA has evaluated all public comments received in response to the proposed rule and is issuing final regulations to implement the act