Agenda

What are the standards for evaluating data and the processes for gathering data, specifically in the context of promotional utilization? How should real-world evidence studies be designed with promotion in mind? How does real-world evidence fit into the framework of the “Consistent with Labeling” and “Payor Communications” guidance documents? This session will discuss use of real-world evidence in the promotion of medical products, the coalescing standards for regulatory support and product promotion, practices and strategies for companies considering its use, and how manufacturers can avoid communicating false and misleading medical product claims.

Eric Gemmen, Senior Director, Epidemiology & Outcomes Research, Real World Evidence, Real World & Analytics Solutions, IQVIA, Inc.
Colleen Heisey, Partner, Jones Day
Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol-Myers Squibb Company
Moderated by Kellie Combs, Partner, Ropes & Gray LLP and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee

This session will provide an update on First Amendment issues in the promotional realm. Speakers will discuss how FDA’s outlook on product communications, as viewed through the lens of the “Consistent with Labeling” and “Payor Communications” guidance documents and its consideration of real-world evidence, relate to FDA’s current approach to First Amendment issues. Speakers will also consider whether FDA’s perspective on commercial speech differs for drugs versus devices; issues related to commercial speech and exclusivity; and potential First Amendment-related reforms.

Jeffrey Chasnow, Senior Vice President and Associate General Counsel, Pfizer, Inc.
Scott Lassman, Partner, Goodwin Procter LLP
Peter Pitts, President, Center for Medicine in the Public Interest
Moderated by Kelly Goldberg, Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA

FDA officials from the agency’s medical product centers – CDER, CBER, CDRH, and CVM – will discuss recent enforcement actions taken by their offices, the importance of these actions for companies, and enforcement priorities. 

Thomas Abrams, Director, Office of Prescription Drug Promotion, CDER, FDA
Thomas Moskal, Veterinary Medical Officer, Post-Approval Review Team, CVM, FDA 
Lisa Stockbridge, Supervisory Consumer Safety Officer, Advertising and Promotion Labeling Branch, CBER, FDA
Deborah Wolf, Regulatory Counsel, Division of Premarket and Labeling Compliance, CDRH, FDA
Moderated by Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide

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 marketing laws and enforcement actions, 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. 

John Bentivoglio, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission
Jason Rose, Partner, Venable LLP
Moderated by James Czaban, Partner, Chair, FDA and Medical Products Practice Group, DLA Piper LLP (US)

FDA’s social science researchers will offer insight into OPDP’s research program and how it supports OPDP’s work regulating prescription drug promotion. They will also discuss the application of their findings, including how their research affects FDA’s approach to gathering data.

Kevin Betts, Social Science Analyst, Office of Prescription Drug Promotion, CDER, FDA
Amie O’Donoghue, Social Science Analyst, Office of Prescription Drug Promotion, CDER, FDA
Helen Sullivan, Social Science Analyst, Office of Prescription Drug Promotion, CDER, FDA
Moderated by Kathryn Aikin, Social Science Team Leader, Office of Prescription Drug Promotion, CDER, FDA

This panel will address both the visible and less-visible aspects of product promotion on the internet. Speakers will consider the technology behind search engine optimization and metadata, which impacts public perception of a product by presenting content. Speakers will also discuss the utilization of visual promotional communications on social media, including space limited platforms, utilization of influencers, independent bloggers, and native advertising.

Mark duPlessis, Celgene Corporation                                    
Jason Gordon, Partner, Reed Smith LLP
Anne Maher, Partner, Kleinfeld, Kaplan & Becker, LLP
Moderated by Dale Cooke, President, PhillyCooke Consulting