FDA Crackdown Intensifies Need to Harness the Power of AI

With FDA cracking down on promotional materials, there's never been a better time to implement AI-solutions that precheck content to ensure compliance with government regulations. AI innovation must be tightly aligned with business needs and corporate readiness.

The Current Enforcement Landscape

The FDA's Office of Prescription Drug Promotion (OPDP) has dramatically increased its enforcement activities. This heightened scrutiny means companies need to be more vigilant than ever about their promotional content.

Where AI Fits In

AI-powered prechecking solutions can help companies:

• Identify potential compliance issues before materials reach MLR review
• Ensure claims are properly supported by references
• Verify that content stays on label
• Flag potential off-label statements
• Check for fair balance issues

Implementation Considerations

When implementing AI for promotional review, companies should consider:

• Integration with existing workflows and systems
• Training and change management needs
• Validation and accuracy requirements
• Scalability for future needs

---

About SecureCHEK AI

SecureCHEK AI uses hybrid AI technology to precheck promotional content and reduce MLR review cycles while ensuring compliance.