Petrick Regulatory Challenges

Regulatory Challenges to Approval of Non-Surgical Animal Sterilants : 

Regulatory Challenges to Approval of Non-Surgical Animal Sterilants David M. Petrick, VMD, JD The Delta Consortium Regulatory Consulting Limited Copyright April, 2010 The Delta Consortium Regulatory Consulting, Ltd.

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Points to Consider Products for use in animals require pre-market approval Federal jurisdiction is determined by mode of action in the USA Labeling is a key factor Cornerstones of approval are safety, efficacy, and quality

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Products for use in animals require pre-market approval Premarket review of animal health products dates to 1913 with the Virus, Serum, and Toxin Act Sweeping legislation in 1938 (Food, Drug, and Cosmetic Act) and in 1962 (Amendments) set standards for scientific review of data to prove products safe and effective prior to sale Animal drugs are subject to many of the same requirements as human pharmaceuticals

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Federal jurisdiction is determined by mode of action in the USA USDA Virus, Serum, Toxin Act Animal Plant Health Inspection Service (“APHIS”) Center for Biologics (“CVB”) Conventional and recombinant production Quality, Safety, Efficacy Associated with a disease

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Federal jurisdiction is determined by mode of action in the USA (cont.) FDA Food, Drug, and Cosmetic Act Center for Veterinary Medicine (“CVM”) All New Animal Drugs as defined by the Act Safety, Efficacy, Quality (cGMP)

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Outside of the USA EU “Veterinary Medicinal Product” EMEA and CVMP Australia Stronger focus on Food Animal Products Japan Accepting of EU dossier Latin America Emerging regulatory environment

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Labeling is a key factor Must define what the product will do Claim of activity Dose Sufficient to achieve desired effect Adequate margin of safety Route of administration Oral Injectable Safety of the administrator Likely to be followed Will the directions for use be followed in practice

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Cornerstones of approval are safety, efficacy, and quality Safety To the Target Animal GLP Safety Study 1,3,5 X design standard Sacrifice study with histopathology To the User Production safety End User and risk assessment To the Environment Either categorical exclusion Environmental Assessment

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Cornerstones of approval are safety, efficacy, and quality (cont.) Efficacy Mandate to prove effectiveness for the claim made Laboratory Field Study(ies) GCP standard “Substantial Evidence of Efficacy”

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Cornerstones of approval are safety, efficacy, and quality (cont.) Quality Good Manufacturing Practice (“GMP”) is a requirement in the EU for all VMPs - Drugs and Biologics GMP is required for New Animal Drugs USDA has separate Quality Guidelines

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Summary Scientific and Legal Standard to be Met Pre-Market Review and Approval Required Agencies with Various Jurisdictions USDA FDA Fish and Wildlife Service (Feral Dogs and Cats) Environmental Protection Agency Regulatory Discretion Emergency Use MUMS

Regulatory Challenges to Approval : 

Regulatory Challenges to Approval Summary (cont.) Definitional Questions Status of Feral Cats and Dogs Pregnancy not a disease, a condition Food, Drug, and Cosmetic Act Federal Insecticide, Fungicide, and Rodenticide Act Memoranda of Understandings USDA & FDA FDA & EPA