Advertising and promotion of FDA-regulated medical products faces scrutiny, compliance challenges, and legal risk from multiple actors in the legal system beyond FDA. Government and industry experts will explore the other sources of compliance obligations and risk, including the FTC, state Attorneys General, state and local legislatures seeking to limit or compel speech in advertising, private litigants in Lanham Act lawsuits, and how drug advertising and promotion, including off-label promotion, impacts mass-tort litigation. Speakers will also explore ways to mitigate risks when facing these challenges.
Moderator
- James Czaban, Partner, Chair, FDA and Medical Products Practice Group, DLA Piper LLP (US)
Speakers
- Jason Rose, Partner, Venable LLP
- Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
- John Bentivoglio, Partner, Skadden, Arps, Slate, Meagher & Flom LLP