Labeling and Promotion

July 22, 2016 12:00pm

Julie Tibbets
Alston & Bird LLP (Washington, DC)

Marian J. Lee
Gibson, Dunn & Crutcher LLP (Washington, DC)

  • Jurisdiction and definitions
    • FDA v. FTC regulation
    • Advertising v. labeling
    • Restricted devices, prescription devices, and OTC devices
  • FTC Requirements for Advertising
    • Introduction to FTC Act
    • FTC requirements for substantiation of health claims
    • FTC requirements for endorsements
    • FTC Guidance, “.com Disclosures”
  • FDA Regulation of Promotion
    • Introduction to FDCA requirements for promotion (misbranding, adulteration)
    • What is off-label?
    • Promotion for various device types: exempt, 510(k), PMA devices
    • Standards for substantiation
    • Risk disclosure
    • Advertising for restricted devices
    • SEC considerations, talking to the press, and cautionary tales
    • What can you say and where?
      • Social Media
      • Draft FDA Guidance “Distributing Scientific and Medical Publications on Unapproved New Uses”
      • Disease awareness activities
  • Enforcement
    • Enforcement trends in device promotion