Wednesday, October 16
5:00– 7:00 PM
Out-of-Towners Reception
Location: Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Ave NW, Washington, DC 20005
Thursday, October 17
Renaissance Downtown Hotel, 999 Ninth St NW, Washington, DC 20001
8:00 – 8:45 AM
Registration and Continental Breakfast
8:45 – 9:00 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, Food and Drug Law Institute (FDLI)
Paul Savidge, US General Counsel, Spark Therapeutics, and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee
9:00 – 9:45 AM
Keynote Address
Lowell Schiller, Principal Associate Commissioner for Policy, FDA
This session will cover how the Department of Justice and the Department of Health and Human Services’ Office of the Inspector General are enforcing off-label promotion and other advertising and promotion-related allegations. Speakers will discuss emerging theories for enforcement, including wire fraud, mail fraud, and conspiracy under Title 18. Lastly, speakers will consider forward-looking goals and priorities for holding companies accountable in this space.
Gustav Eyler, Branch Director, Consumer Protection Branch, US Department of Justice
Mary Riordan, Senior Counsel, Office of Counsel, Office of the Inspector General, US Department of Health and Human Services
Moderated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Chair, FDLI Board of Directors
10:45 – 11:15 AM
Networking & Coffee Break
11:15 – 12:15 PM
Concurrent Breakout Sessions
12:15 – 1:15 PM
Networking Luncheon
1:15 – 1:30 PM
Transition
1:30 – 2:45 PM
Concurrent Breakout Sessions: Hypothetical case studies will focus on specific issues and examples addressing pressing advertising and promotional issues as they affect the pharmaceutical, medical device, and veterinary medicine industries
2:45 – 3:00 PM
Networking Break & Coffee Break
5:00 – 6:30 PM
Networking Reception
Friday, October 18
8:30 – 8:55 AM
Registration and Continental Breakfast
8:55 – 9:00 AM
Welcome and Announcements
Laura Brown, Director, Educational Programs, FDLI
Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol-Myers Squibb Company, and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee
10:45 – 11:00 AM
Networking & Coffee Break
11:00 AM – 12:00 PM
Concurrent Breakout Sessions
12:00 – 12:15 PM
Transition
12:15 – 1:15 PM
Facilitated Table Topic Discussions
1:15 – 2:15 PM
Concurrent Breakout Sessions
2:15 – 2:20 PM
Transition
3:30 PM
Conference Adjournment