Regulation of Generic Animal Drugs in the United States VICH Outreach Forum June 25, 2014 Brussels, Belgium

What is a Generic New Animal Drug? Copy of an FDA-approved brand-name reference listed new animal drug (RLNAD) Same as brand name drug in dosage form, strength, route of administration, quality, performance characteristics, and intended use Must demonstrate bioequivalence to the RLNAD or qualify for a waiver of this requirement (biowaiver) Manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs

What is the Law that provides for Generic Animal Drugs? Generic Animal Drug and Patent Term Restoration Act (GADPTRA) Amended the Federal Food Drug and Cosmetic Act in 1988. Approval of generic new animal drugs Patent term restoration

GADPTRA Requirements for approval of a generic animal drug Same active ingredient, concentration (strength), dosage form, and route of administration Bioequivalent to the approved pioneer drug product Sameness in labeling

GADPTRA Patent term restoration Provision allowing for additional years to be added to the RLNAD patent based on the time required for drug approval Exclusivity periods 3-year Marketing exclusivity for addition of new species or claim to an approved drug label 5-year Marketing exclusivity for new drug entity never approved before

What differences can a generic drug have from the RLNAD? Suitability Petition Provision for requesting a change in active ingredient (combination products), route of administration, dosage form, and/or strength from that of an approved reference listed new animal drug Petition is approved unless new safety and effectiveness studies are required for requested change(s) Labeling changes are permitted consistent with the change granted. e.g., change in dosage form may require different instructions for use or administration

What is the Regulatory Process for Generic Animal Drugs? Generic Investigational New Animal Drug (JINAD) File Identify the RLNAD Request biowaiver for selected drug products Option to do phased review of each technical section: Environmental, Patent and Marketing Exclusivity, Bioequivalence, Chemistry, and Labeling When completed – submit an administrative application.

What is the Regulatory Process for Generic Animal Drugs? Abbreviated New Animal Drug Application (ANADA) File containing all the technical sections for approval New target animal safety and effectiveness trials or Human Food Safety information (other than tissue residue data for drugs used in food producing animals) are not required Tissue residue data are not required for drug products that are granted a biowaiver

What innovations can be made to a generic animal drug? Sponsor may also request a change requiring new safety and effectiveness studies to support the request. i.e., new claim, species, or indication Approval process B1 supplement: Two step process – get approval of an ANADA then submit a supplement with new data. The new claim may qualify for a 3-year marketing exclusivity

Animal Generic Drug User Fee Act (AGDUFA) August 14, 2008, signed into law by President Bush This Act amends the Food, Drug and Cosmetic Act Authorizing the first ever generic animal drug user fee program A first for either human or animal generic drugs The program provides consumers with multiple sources of animal drugs, better ensuring an adequate supply of animal drugs

AGDUFA The program provides consumers with multiple sources of animal drugs, better ensuring an adequate supply of animal drugs The performance of the generic new animal drug review process is enhanced Allows FDA to better ensure that generic new animal drug products are safe and effective

Questions?