Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

Great Seal of the United States (obverse)

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 (ADUFA and AGDUFA) is a significant piece of legislation in the United States that was enacted to amend the Federal Food, Drug, and Cosmetic Act. This act is crucial for the regulation and oversight of animal drugs and generic animal drugs, ensuring they are safe, effective, and available to protect animal health. The legislation authorizes the Food and Drug Administration (FDA) to collect fees from companies that produce certain animal drugs. The fees collected are used to fund the review of animal drugs by the FDA, aiming to expedite the process and improve the efficiency of the regulatory review process for animal drugs and generic animal drugs.

Background

The original ADUFA was enacted in 2003, with the goal of enhancing the speed and efficiency of the regulatory review process for animal drugs. Similarly, AGDUFA, modeled after ADUFA, was established for generic animal drugs and was first enacted in 2008. These acts were created in response to concerns about the lengthy FDA review process for animal drugs, which was seen as a barrier to the introduction of new and generic animal drugs into the market.

Provisions of the Act

The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 reauthorized the collection of user fees for five more years. Key provisions of the act include:

• Fee Structure: The act outlines the fees that the FDA can collect from animal drug manufacturers, including application fees for new animal drug applications, supplemental applications for changes to existing animal drugs, and annual product and establishment fees.
• Performance Goals: The legislation sets specific performance goals for the FDA, such as timelines for the review of animal drug applications. These goals are intended to ensure that the review process is both timely and thorough.
• Public Health Protection: By facilitating faster access to new and generic animal drugs, the act aims to protect public health by ensuring that veterinarians and animal owners have access to effective treatments for animal diseases.
• Innovation and Competition: The act supports innovation in the development of new animal drugs and promotes competition by improving the availability of generic animal drugs.

Impact

The reauthorization of ADUFA and AGDUFA in 2013 has had a significant impact on the animal health industry and animal healthcare overall. By providing the FDA with the necessary resources to review animal drug applications more efficiently, the acts have contributed to a more robust and competitive market for animal drugs. This has benefits for animal health, including improved access to treatments and advancements in animal healthcare.

Controversies and Challenges

While the reauthorization of ADUFA and AGDUFA has been largely positive, there have been concerns regarding the reliance on user fees to fund the FDA's review process. Critics argue that this could potentially create a conflict of interest, where the FDA might prioritize applications from companies that contribute significant fees. Additionally, there are ongoing discussions about the transparency of the review process and the need for further improvements to ensure the safety and efficacy of animal drugs.

Conclusion

The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 represents a critical step forward in the regulation of animal drugs and generic animal drugs in the United States. By streamlining the review process and providing the FDA with the resources needed to perform its duties effectively, the act ensures that animal health products are brought to market in a timely manner, benefiting animals, their owners, and public health.