Advertising & Promotion - Webinar Recording/Transcript
Advertising & Promotion: Compliance Tips from Recent Warning and Untitled Letters
Drug and device makers must advertise to survive, but the legal issues surrounding advertising and promotion are far from settled. FDA enforcement actions don’t seem to show a consistent pattern, leaving you to guess whether a warning letter lurks ahead and how to avoid it.
But the FDA has left a paper trail in recently issued untitled and warning letters. Now, two of Washington’s top FDA lawyers have analyzed those documents and teased out patterns to help you stay in the clear.
In a fast-paced hour and half heavy on case studies and analysis, Kellie Combs Esq. and Josh Oyster Esq. of Ropes & Gray LLP disclose:
- FDA enforcement priorities: What on-the-record actions tell you about how the agency actually views presentation of false or misleading risk information and other hot-button issues
- Specifically: Safety and risk information; Communicating pre-approval; describing FDA-approved or -cleared uses; disclaimers and contextualizing information
- Case studies: How historical enforcement may interplay with recent draft guidance on manufacturer communications, including use of subgroup analyses and patient-reported outcomes
- Tips for responding to warning and untitled letters and implementing corrective action plans
- Best practices for promotional review committees, including committee composition, scope of covered materials and review guidelines
- And much more!