FDA Compliance Checklist for Pharmaceutical Promotional Materials
A comprehensive guide to ensuring your pharmaceutical promotional content meets FDA OPDP regulations and industry standards.
Understanding FDA OPDP Regulations
The FDA's Office of Prescription Drug Promotion (OPDP) oversees pharmaceutical promotional materials to ensure they are truthful, balanced, and adequately substantiated. This guide covers essential compliance requirements.
Key FDA Compliance Requirements
- Fair balance between benefits and risks
- Adequate substantiation for all claims
- Proper reference citation
- Clear indication and usage information
- Complete prescribing information (PI) or brief summary
Common Compliance Pitfalls
Medical affairs teams often encounter challenges with claim substantiation, overstating efficacy, minimizing risks, and inadequate reference documentation. Understanding these pitfalls helps ensure compliant promotional materials.
Best Practices for Compliance
Implement automated compliance checking, maintain comprehensive audit trails, establish clear MLR workflows, and regularly train your medical affairs team on current FDA regulations.