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?