Advertising, Promotions, and Related First Amendment Concerns
PART 1: Drug and Biologics Advertising and Promotion 101
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