Generic Animal Drug Alliance

The Generic Animal Drug Alliance (GADA) is a nonprofit organization that serves as the primary independent, professional trade association for companies involved in the generic animal drug industry in the United States.

History and Mission

Established to address the needs and challenges faced by generic animal drug manufacturers, GADA supports organizations with interests in generic investigational new animal drugs (JINADs) and those with approved or pending abbreviated new animal drug applications (ANADAs). The organization's mission is centered around advocacy for regulatory and legislative improvements that benefit the veterinary pharmaceutical and animal health industries.

Activities and Advocacy

GADA focuses on addressing regulatory challenges faced by generic animal drug companies, particularly in areas such as bioequivalence requirements and the use of Type A Medicated Articles in feed formulations. The organization has engaged in efforts to simplify the approval process for generic animal drugs, especially concerning bioequivalence testing across multiple species. GADA supports legislative changes aimed at streamlining these processes, such as the Generic Animal Drug Advancement Act, which would allow generic drugs to be approved for single species rather than all species listed on the pioneer drug's label.

Membership and Benefits

GADA membership includes a diverse range of organizations involved in the generic animal drug sector, from small consulting firms to large pharmaceutical companies. Members benefit from access to educational resources, opportunities to influence policy, and participation in advocacy efforts to improve the regulatory environment for generic animal drugs.

Context and Impact

GADA operates within the framework of laws such as the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988, which was modeled after the Hatch-Waxman Act for human drugs. This legislation aimed to facilitate the approval of generic animal drugs, taking into account the unique challenges associated with multiple species use in veterinary medicine. Through its advocacy, GADA works to ensure that generic animal drugs play a vital role in maintaining animal health and the integrity of the human food supply.