The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is launching a pilot program that offers sponsors of new animal drugs a faster, more flexible path to showing an animal drug residue testing method meets specific FDA standards, which is a required step in the approval process for a new animal drug for a food-producing species.
Under the Federal Food, Drug, and Cosmetic Act, animal drug sponsors must submit a practicable method for detecting the residues of a prospective new animal drug in meat, milk, eggs, and honey from treated food-producing animals. For residue methods, a practicable analytical method is one that is valid, reproducible, and usable in a government laboratory setting.
Typically, meeting this requirement has involved a lengthy interlaboratory trial in which sponsors had to show that a testing method can be successfully and reliably used by a government laboratory to detect a drug’s residues in foods derived from treated animals.
This process alone can take approximately two years. In some cases, sponsors have had to modify their method before the trial could begin, a step that has required an entirely separate validation study, pushing timelines out even further.
The 2024 reauthorization of the Animal Drug User Fee Act (ADUFA V) included a five-year agreement between the FDA and the animal health industry that sets goals and commitments for the new animal drug review program. As part of that agreement, CVM worked closely with industry stakeholders to explore streamlined, modernized ways to meet the statutory requirements related to residue analytical methods. The result of that collaboration is a pilot program called Risk-Based Tiered Approach to Demonstrate Residue Analytical Method Practicability.
The approach relies on CVM's confidence in a method's reproducibility and usability in a government laboratory. The more closely a method resembles a method already used and trusted by the FDA and the U.S. Department of Agriculture, the lower the risk tier and the fewer steps to demonstrate practicability. The pilot covers Tier 1 (negligible risk), Tier 2 (low risk), and Tier 3 (moderate risk). A companion One Method Approach document integrates validation criteria from VICH GL49 and Guidance for Industry #3. As part of the pilot, sponsors conduct a single method validation study that can be used in residue depletion studies and serve as the basis of the practicable method, eliminating the need for a separate validation study and, in many cases, a separate animal study. Compared with the previous process, the Risk-Based Tiered Approach may reduce the overall time to complete the human food safety residue evaluation by approximately two years.
The pilot will remain in effect until at least three new animal drug products have completed the Tier 2 or Tier 3 process, or (assuming the user fee program is reauthorized) until the end of ADUFA VI, whichever occurs first. CVM may update the pilot program documents based on lessons learned during implementation, so sponsors should contact CVM to verify they are referencing the most current versions.
Participation in this pilot is voluntary. Animal drug sponsors interested in participating are encouraged to contact CVM early in the development process to maximize potential time savings.
