Advertising, Promotions, and Related First Amendment Concerns

PART 1: Drug and Biologics Advertising and Promotion 101

March 23, 2023 9:45am

Bryant M. Godfrey
Partner and Co-Chair, Healthcare & Life Sciences and FDA Practice Groups
Foley Hoag LLP
(Washington, DC)

  • Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
    • 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA
    • Guidance documents
  • Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications)
    • What duties and responsibilities is DDMAC charged with?
    • What are its enforcement capabilities and jurisdiction?
  • Identifying the role of the FTC in the advertising and promotion of drugs
    • SEC?
  • Advertising requirements for prescription v. nonprescription products
  • Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
    • Overview of the promotional materials submission and review process
  • What constitutes a launch?
  • What defines an advertisement?
    • What information must a drug advertisement include?
  • Exploring the role of the label in advertising