ANIMAL HEALTH

Animal health companies range from those that manufacture prescription drugs for large and small animals to pet foods. The industry is growing and attracting much of its management and financing from the human side. This presents new challenges as the FDA regulates animal health very differently than human health companies. Thompson Coburn counsels animal health companies on a diverse group of issues, including how to market a supplement-type product, the filing of New Animal Drug applications and filing for and receiving a MUMS designation.

For our animal health company clients we:

• Advise and file New Animal Drug Applications
• Advise and file for MUMS designation
• Advise and file Animal Feed Additive Petitions
• Act as regulatory counsel on initial public offerings
• Negotiate license agreements from human health companies for animal health use
• Advise on marketing and advertising compliance strategies
• Advise on compliant manufacturing practice, including responding to FDA inspections
• Counsel on medicated feed regulations, the animal drug development processes, and developing protocols for pivotal field studies
• Counsel on recalls when tainted feed is suspected or confirmed
• Counsel on FTC and FDA investigations into misbranded, mislabeled and adulterated products, as well as marketing claims
• Counsel on issues related to obtaining animal vaccine approvals from the USDA
• Counsel on import/export issues and foreign manufacturing facility compliance
• Counsel on regulation of animal supplements
• Counsel on mergers and acquisitions
  
  In addition, animal health companies, particularly those that are in the animal feed or supplement area, require assistance in understanding and complying with the new regulations that have been promulgated under the Food Safety Modernization Act. These new rules are complicated and require a new level of compliance, including analysis and documentation of hazards that are inherent in the manufacturing and packaging process and written plans to manage these hazards. We are counseling our clients on how to engage in this analysis and draft these plans.