Minor Use Animal Drug Program

Minor Use Animal Drug Program (MUADP) is a regulatory program in the United States designed to facilitate the development and approval of drugs for minor use in major species or for use in minor species. A minor use is defined as an indication in a major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that occurs infrequently and in only a small number of animals or in limited geographical areas and in specific conditions. Conversely, minor species include all animals that are not considered major species, such as fish, sheep, goats, bees, and zoo animals. The program is crucial for ensuring that these animals have access to effective and safe medications, despite the lack of financial incentives for pharmaceutical companies to develop drugs for these less common applications.

Background

The need for the MUADP arose from the recognition that many animal species or conditions within major species lacked appropriate therapeutic options due to the high costs of drug development and the relatively small market size, which discouraged pharmaceutical companies from investing in these areas. To address this gap, the United States Congress passed legislation to support the development of drugs for these animals and conditions.

Legislation

The key piece of legislation that established the framework for the MUADP is the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). The MUMS Act aims to make more medications legally available to veterinarians and animal owners for the treatment of minor species and for minor uses in major species. It provides incentives for drug companies to bring needed drugs to market, including exclusive marketing rights and grants to offset the costs of safety and effectiveness testing.

Administration

The MUADP is administered by the Center for Veterinary Medicine (CVM), a branch of the Food and Drug Administration (FDA). The CVM is responsible for evaluating and approving animal drug applications under the program, ensuring that they meet the agency's standards for safety and effectiveness.

Key Provisions

The MUMS Act includes several key provisions to encourage the development of drugs for minor uses and minor species:

• Designation: A drug can be designated for minor use or minor species, which qualifies it for certain incentives.
• Exclusive Marketing Rights: Drugs approved under the program may receive up to seven years of exclusive marketing rights, preventing similar drugs from being approved during that time.
• Grants and Contracts: The FDA can award grants and enter into contracts to fund the development and testing of designated drugs.
• Conditional Approval: The FDA can grant conditional approval for a drug for up to five years while the sponsor collects the required effectiveness data, allowing the drug to be marketed during this period.

Impact

The MUADP has had a significant impact on the availability of drugs for minor species and minor uses in major species. It has facilitated the approval of numerous medications that would otherwise not be available, improving the health and welfare of a wide range of animals. The program also supports the needs of specialty markets, such as aquaculture and exotic pets, and addresses public health concerns by providing treatments for diseases that can be transmitted from animals to humans.

Challenges

Despite its successes, the MUADP faces challenges, including limited funding for grants and the inherent difficulties of drug development for a small market. There is also a need for ongoing outreach to educate veterinarians and animal owners about the program and the options it provides.