Agenda & Speakers Slides

Day 1: Agenda & Speakers Slides
Day 2: Agenda & Speaker Slides
Print Agenda (PDF)
Attendee List (PDF)
Speaker Biographies (PDF)

Thursday, October 17

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)

9:00 – 9:45 AM 

Keynote Address
Lowell Schiller, Principal Associate Commissioner for Policy, FDA

9:45 – 10:45 AM

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, U.S. Department of Justice
Mary Riordan, Senior Counsel, Office of Counsel, Office of the Inspector General, U.S. 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

Coffee and Networking Break

11:15 AM – 12:15 PM 

Concurrent Breakout Sessions

During this session speakers will discuss how to lawfully engage patients and patient groups in areas such as unbranded disease awareness, branded patient ambassadors, and patient support programs and access. Speakers will discuss FDA regulations and historic enforcement trends as well as cover issues including overstating efficacy, broadening indication, quality of life, importance of imagery, and patient profiles.

Ryan Hohman, Vice President–Public Affairs, Friends of Cancer Research
Tim Kreidler, Sr. Director of Regulatory Affairs – Commercialization, Dermira, Inc.
Jennifer Romanski, Principal, Porzio, Bromberg & Newman, P.C.
Moderated by Abraham Gitterman, Associate, Arnold & Porter LLP

Now that the Payor Guidance is over a year old, what challenges are companies encountering in communicating health care economic information to payors? How are they overcoming these challenges? This panel will provide helpful examples and solutions for industry.

Michael S. Labson, Partner, Covington & Burling LLP
Paul Savidge, US General Counsel, Spark Therapeutics and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee 
Jay Weaver, Associate Vice President, Pharmacy at Blue Cross and Blue Shield of Illinois, Montana, New Mexico, Oklahoma & Texas
Moderated by Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide

This panel will explore the challenging task of ensuring fair balance and risk disclosure in product advertising. Speakers will discuss ways FDA has approached this issue in the past in terms of the Brief Summary and Adequate Directions for Use draft guidance, and the effect of the anticipated final rule on the Major Statement for Direct-to-Consumer Advertisements. Examples will be provided regarding how companies have tackled fair balance in various formats and how risk disclosure may be impacted in the future by ongoing research from FDA’s Office of Prescription Drug Promotion (OPDP). 

Bryant Godfrey, Counsel, Arnold & Porter LLP
Richard Lem, Associate Director, Advertising and Promotion, North American Regulatory Affairs, Bayer HealthCare, Inc.

12:00 – 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

This interactive session will explore a case study addressing a prescription drug product’s proposed promotional materials. It will include review and discussion of the implications of the Consistent with the FDA-Required Labeling (CFL) guidance on these materials and how to apply it effectively.

Cynthia Meyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Jack A. Scannelli, Head- Regulatory Advertising & Promotion, Novartis Pharmaceuticals Corporation
Moderated by Rebecca Burnett, Exec Director and Head of Strategic Services, Framework Solutions

This session will review promotional materials for a medical device that treats atrial fibrillation. This case study will examine several examples of how the company can effectively and compliantly maneuver its way through social media, including re-tweeting posts authored by health care professionals who are both directly and indirectly involved in these devices.

Madhavi Bellamkonda, Director, Regulatory Affairs, Advertising and Promotion, Abbott Vascular
Lynn Deutsch, Founder, President, Regulatory Promo, LLC
Jeffrey Shapiro, Director, Hyman, Phelps & McNamara, PC
Deborah Wolf, Regulatory Counsel, Division of Premarket and Labeling Compliance, CDRH

This session will provide a case study based on advertising and promotion issues for animal health products. We will discuss animal health product study data requirements, as well as specific requirements for animal health commercial product comparisons versus those for human health. The panel will also explore the difference in enforcement actions taken by Center for Veterinary Medicine (CVM) versus OPDP and the nature of those actions.

Jeannie Perron, Partner, Covington & Burling LLP
Dorothy McAdams, Supervisory Veterinary Medical Officer, Center for Veterinary Medicine, U.S. Food and Drug Administration

2:45 – 3:00 PM 

Coffee and Networking Break

3:00 – 4:00 PM 

After describing the kinds of letters FDA may send a company, speakers will discuss common areas of FDA scrutiny, how to communicate internally about a violation letter, what internal steps to take, and timelines for responding. Speakers will also cover issues such as how to respond when more than one company is involved and special considerations regarding accelerated approvals and combination therapies.

Virginia Foley, Principal Consultant, Opus Regulatory, Inc.
Lauren Miller, Corporate Counsel, Otsuka America Pharmaceutical, Inc.
Dolores Shank-Samiec, Executive Director, Office of Promotion and Advertising Review, Merck & Co., Inc.
Moderated by Vernessa Pollard, Partner, McDermott Will & Emery

4:00 – 5:00 PM

Federal and state developments regarding drug price transparency are quickly evolving. During this session, panelists will discuss the goals and legal viability of rules and policy statements that have been put forth thus far, as well as recent industry pushback on First Amendment grounds. Speakers will then engage in a discussion about methods companies are using to deal with the recent push for price disclosures and what regulatory implications may ensue if drug pricing measures come to fruition.

Jim N. Czaban, Partner, DLA Piper LLP (US)
Kelly Goldberg, Vice President, Law/Senior Counsel for Biopharmaceutical Regulation, PhRMA
Colin Goldfinch, Senior Health Policy Advisor, Senate HELP Committee
Moderated by James Davidson, Shareholder, Polsinelli PC

5:00 – 6:30 PM

Networking Reception