Why Attend

Agenda

Agenda Subject to Change

Location & CLE

Preliminary Agenda

Wednesday, October 16

5:30– 7:00 PM
Out-of-Towners Reception 

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)

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.


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

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.

Abraham Gitterman, Associate, Arnold & Porter LLP
Tim Kreidler, Sr. Director of Regulatory Affairs – Commercialization,
Dermira, Inc.

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.

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). 

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 address 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.

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

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

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.

2:45 – 3:00 PM
Networking Break & Coffee Break

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.

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)

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

What are social media companies’ policies and approaches regarding industry engagement? This session will feature representatives who host and navigate social media platforms that grapple with medical product advertising and promotion issues on a daily basis. Speakers will discuss emerging issues, specifically focusing on policies regarding patient engagement, the role of influencers, and drug warnings.

Moderated by Heather Banuelos, Counsel, King & Spalding LLP

This panel will discuss steps companies are increasingly taking to address concerns about competitor promotional activities regarding false or misleading statements. Speakers will explore recent developments in private advertising enforcement and litigation between companies under the Lanham Act, similar state false advertising and unfair trade practice laws, and product liability claims. The Better Business Bureau’s National Advertising Division (NAD) process for addressing competitor claims and how sales and marketing can influence a company’s ability to fairly defend the company in product liability disputes will also be addressed.

Lisa Molot Dwyer, Partner, King & Spalding LLP
Meredith Manning, Partner, Hogan Lovells US LLP
Kirke Weaver, Vice President, Office of General Counsel, Merck & Co., Inc.

10:45 – 11:00 AM
Networking & Coffee Break

 10:45 – 11:00 AM
Concurrent Breakout Sessions

This session will discuss FDA’s implementation of, and industry experiences with, the “Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs” guidance. FDA will answer questions submitted by you for this conference that industry has about the implementation process.

Jason Cober, Project Manager Team Lead, Office of Prescription Drug Promotion, CDER, FDA
Moderated by Joanne Hathaway, Manager, Global Regulatory Affairs, Promotion Compliance, Otsuka America Pharmaceutical, Inc.

This panel will discuss advertising and promotion dilemmas with which medical product companies often wrestle: balancing marketing important and sometimes lifesaving products, satisfying stakeholders, and ensuring fair balance in claims. Speakers will cover mistakes companies have made in the past that have led to adverse jury verdicts and steps industry can take to lower risk.

Matthew Keenan, Law Partner, Shook, Hardy & Bacon LLP

What is “scientific exchange?” When is it appropriately used? Where is the line between scientific exchange and off-label promotion? This panel will discuss where these grey areas are and how to use scientific exchange effectively while still complying with regulatory requirements.

Kellie Combs, Partner, Ropes & Gray LLP
Moderated by Elllen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol-Myers Squibb Company and and Co-Chair, Advertising & Promotion for Medical Products Conference Planning Committee

10:45 – 11:00 AM
Transition

12:15 – 1:15 PM
Facilitated Table Topic Discussions

1:15 – 2:15 PM
Concurrent Breakout Sessions

During this panel speakers will discuss some of the challenges of making comparative claims when launching a new therapy into a therapeutic or pharmacological class with a variety of existing approved products. Although the general rule is that comparative claims require substantiating data from two head-to-head registration-quality studies demonstrating very significant differences, some statements about competing products that vary from this standard are expressly permitted by the agency, if properly executed. Speakers will examine how changes under the CFL guidance have affected the ability to make comparative claims, as well as practical strategies to manage risk.

Coleen E. Klasmeier, Partner, Sidley Austin LLP

In this era of bloggers and celebrity endorsements, this session will discuss how to work effectively with influencers to ensure actions taken and statements made are in compliance with FDA and Federal Trade Commission (FTC) regulations. Speakers will discuss specific issues to watch for when working with influencers in the social media space, how to stem the tide of inaccurate information, and recent enforcement examples.

Jason Gordon, Partner, Reed Smith LLP
Danielle Humphrey, Counsel, Hogan Lovells US LLP

This session will address how companies deal with common promotional challenges in the face of regulatory uncertainty, as well as associated risks. Issues addressed will include: whether it is “off-label” to make a specific claim when the device has a more general indication for use; how much safety information must be included in device advertisements and promotional labeling; implications of the CFL Guidance as applied to devices; promotion of combination drug/device products and restricted/Rx devices;  and preapproval/preclearance promotion.

Greg Levine, Partner, Ropes & Gray LLP

2:15 – 2:20 PM
Transition

Companies are increasingly using new technologies such as AI/ML, Alexa, disease monitoring apps that include a branded product, and digital advertising at the point of care, including on electronic health records, for promotional purposes. Speakers will discuss benefits and risks of using these technologies to better engage with doctors and patients on product information or disease education, develop precision messaging, probe real world data for development of healthcare economic models, speed access through coverage and reimbursement, identify patient adherence issues, engage with patients, and anticipate future prescribing trends. Speakers will address privacy issues as well as how to maintain regulatory compliance and ensure best practices.

Daniel Kracov, Partner, Arnold & Porter LLP, and Secretary and General Counsel, FDLI Board of Directors
Dale Cooke, President, PhillyCooke

3:30 PM
Conference Adjournment