Advertising & Promotion - Webinar Recording/Transcript

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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  • Case studies: How historical enforcement may interplay with recent draft guidance on manufacturer communications, including use of subgroup analyses and patient-reported outcomes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!
  • Executive suite
  • Advertising and marketing
  • Social media
  • Promotion review committee members
  • Medical affairs
  • Continuing education
  • Tradeshow organizers
  • Regulatory affairs
  • PRC coordinators
  • Legal counsel/outside counsel
  • Outside ad agencies and marketing consultants

Meet Your Presenters

Kellie Combs Esq. is Partner in the Life Sciences group at Ropes & Gray LLP, where she provides legal and strategic advice to drug, biotech and device manufacturers.  She boasts extensive experience handling matters implicating FDA promotional rules and the First Amendment; government investigations; regulatory due diligence; lifecycle management; clinical research regulation, and post-approval compliance.

Josh Oyster Esq. is an Associate in the Life Sciences practice group at Ropes & Gray LLP where he specializes in drug and device advertising and promotion, including the impact of evolving FDA policies and their interplay with First Amendment issues.