This must-attend event for medical product industry stakeholders brings together regulatory practitioners, industry experts, and government officials to engage on the latest trends and updates in advertising and promotion through panel discussions and case studies.
Practical Takeaways: Explore the current state of off-label promotion, how to evaluate and use real-world evidence, and the increased focus on scientific exchanges.
FDA Speakers: Representatives from CBER, CDER, CDRH, and CVM will provide the latest information on policy, enforcement, and future initiatives.
Peer Interaction: Network with and learn from legal and regulatory experts.
- Utilization of Real-World Evidence
- Scientific Exchange
- Digital Health Technologies and Communications
- Operationalizing FDA’s Recent Guidance Documents
- OIG Compliance Trends and Significant Developments
- Submissions of Promotional Materials
- FDA Enforcement Actions
- Effectively Responding to FDA Warning Letters
- Advertising and Promotion Requirements for Biologics and Biosimilars
Last Year’s Agenda
subject to change
Monday, September 25
At Latham & Watkins LLP
555 11th St NW, Washington, DC 20004
1:00 – 5:00 PM
Introduction to Advertising and Promotion
Add this half-day course to your registration and save $100 on the combined registration fees.
Tuesday, September 26
At Renaissance Downtown Hotel
999 Ninth St NW, Washington, DC 20001
Registration and Continental Breakfast
Amy Comstock Rick, President & CEO, Food and Drug Law Institute (FDLI)
FDA’s Advertising and Promotion Initiatives and Recent Guidance Documents
FDA will be presenting on two draft guidance documents related to medical product communications. The agency will share their thinking on communication of health care economic information (HCEI) to payors about approved drugs, and their recommendations regarding communications to payors about investigational drugs and devices that are not yet approved or cleared for any use. FDA will also discuss the draft guidance concerning medical communications that include data and information that are not contained in a products’ FDA-required labeling, but that are consistent with the approved or cleared FDA-required labeling for the products.
Elizabeth Pepinsky, Health Science Policy Analyst, Office of Prescription Drug Promotion, CDER, FDA
Sheila Ryan, Health Science Policy Analyst Team Leader, Office of Prescription Drug Promotion, CDER, FDA
Moderated by Catherine Gray, Senior Consumer Safety Officer, Office of Prescription Drug Promotion, CDER, FDA
Off-Label Regulation, Compliance, and Enforcement under the New Administration
FDA is wrestling with a line of judicial opinions reiterating commercial free speech protection of truthful and non-misleading manufacturer off-label promotion. This panel of FDA experts will analyze the current outlook with respect to off-label regulation, compliance, and enforcement.
John A. Murphy, Deputy General Counsel, Biotechnology Innovation Organization
Peter Pitts, President, Center for Medicine in the Public Interest
Marc J. Scheineson, Partner, Alston & Bird LLP
Moderated by James N. Czaban, Partner, DLA Piper LLP
Coffee Networking Break
- Proactive and Reactive Strategies and Tactical Approaches for Communicating with FDA
Best communications practices for engaging with FDA are crucial for medical product industry stakeholders. Communication challenges with the Agency can erode a positive working relationship and exacerbate potential regulatory issues. This session will identify key strategies for facilitating efficient and effective interactions with FDA in multiple contexts, including advisory letters, competitor complaints, responding to warning letters, and communicating proposed corrective actions.
Katlin Backfield, Attorney, Backfield PLLC
Michele L. Sharp, Sr. Director, Global Regulatory Affairs – US, Eli Lilly and Company
Norma Skolnik, Independent Consultant, EAS Consulting Group, LLC
- Enhancing Patient Centricity: Communication and Involvement
Currently, several steps are being taken toward encouraging inclusion of patient perspectives in drug development and clinical trial recruitment and communication. Hear from leading experts about FDA’s guidance for industry, direct-to-consumer advertising, and the use of patient ambassadors.
Jennifer Romanski,Principal, Porzio, Bromberg & Newman, PC
Lance L. Shea, Partner, BakerHostetler LLP
- Advertising and Promotion of Biological Products Including Biosimilars
With the recent approval of biosimilars, there is an increasing focus on the commercialization of biosimilars and the effect of biosimilars on biologic advertising and promotion activities. Currently, the information available in the approved biosimilar label does not help a prescriber understand what a biosimilar is, or how it relates to the reference product. Does the discussion of biosimilar clinical studies constitute off-label communication, if it is not mentioned on the label? Can messaging on whether biosimilars are “identical” or “different” than their reference product survive the historic comparative advertising rules?
Daniel A. Kracov,Partner, Arnold & Porter Kaye Scholer LLP and Member, FDLI Board of Directors
Bruce A. Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
Michael K. Stern, Special Counsel, Covington & Burling LLP
Moderated by Kate Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health LLC
Recent FDA Enforcement Actions
FDA officials from the agency’s four medical product centers will discuss recent enforcement actions taken by their offices, the basis for the actions, and the implications and importance of these actions for companies.
Thomas W. Abrams, Director, Office of Prescription Drug Promotion, CDER, FDA
Kendra Jones, Lead Consumer Safety Officer, Division of Premarket and Labeling Compliance, CDRH, FDA
Thomas Moskal, Veterinary Medical Officer, Post-Approval Review Team, CVM, FDA
Lisa Stockbridge, Branch Chief, Advertising and Promotion Labeling Branch, CBER, FDA
Moderated by Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide, and Planning Committee Co-Chair
Coffee and Networking Break
FDA’s Social Science Research
Social Science researchers in FDA’s Office of Prescription Drug Promotion (OPDP) will present topics of their own research and will highlight plans for upcoming research. This session with offer insight into OPDP’s Research program and how it supports the Office’s work regulating prescription drug promotion.
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
Advertising and Promotional Communications in a Mobile World
This session explores a variety of different uses of mobile communications, recent FTC and FDA guidance, and how to approach the review and approval of such materials. In addition to providing updates on how to ensure that mobile apps comply with all relevant laws and regulations, this session will also explore advertising within apps, text messaging, and other challenges in mobile promotions.
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Jason W. Gordon, Counsel, Reed Smith LLP
Kristi Wolff, Partner, Kelley Drye & Warren LLP
Moderated by Dale Cooke, President, PhillyCooke Consulting
Wednesday, September 27
At Renaissance Downtown Hotel
999 Ninth St NW, Washington, DC 20001
Laura Brown, Director, Educational Programs, FDLI
Decision Making and Risk Assessment in Advertising and Promotion
In today’s increasingly complex regulatory/legal world, “what would FDA say” is simply not enough. In the opening session for day two, this panel will bridge diverse considerations a company must evaluate when analyzing risks and benefits of a marketing program. Using real scenarios in a discussion format, highly experienced industry executives will discuss the detailed analyses necessary to construct effective marketing programs, through the lens of the FDA and other government agencies, payers, healthcare professionals and patients, and the courts.
Geoffrey M. Levitt, SVP & Associate General Counsel, Pfizer, Inc.
Kathleen Meriwether, Americas Leader – Life Sciences, Fraud Investigation & Dispute Resolution, Ernst & Young LLP
Paul Savidge, US General Counsel, Spark Therapeutics, Inc.
Moderated by Lucy Rose, President, Lucy Rose & Associates, LLC, and Planning Committee Co-Chair
OIG Compliance and Enforcement Trends and Developments
This interview with one of HHS OIG’s senior attorneys will focus on recent enforcement actions, the agency’s current priorities, and whether the new Administration will have an impact on the agency’s current and future activities. There will be time at the end of the session for audience Q&A.
Mary Riordan, Senior Counsel, Office of the Inspector General, HHS
Moderated by John Bentivoglio, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Coffee and Networking Break
- Proactive Communications about Medical Products between Manufacturers and Payors
In January 2017, FDA released the long-awaited guidance on the proactive dissemination of healthcare economic information (HCEI) by manufacturers to payors. However, there are still unanswered questions and areas requiring further clarification to truly operationalize proactive communications. This session will discuss the changes instituted by the guidance, how the future state of proactive communications will impact industry, and strategies for delivering compliant HCEI to meet the needs of payors.
David J. Bloch, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
Joseph Demers, Advertising and Promotion Regulatory Lead, Spark Therapeutics, Inc.
Soumi Saha, Director of Pharmacy & Regulatory Affairs, Academy of Managed Care Pharmacy
Moderated by Mark Gaydos, Vice President, NA General Medicine/US Advertising & Promotion, Global Regulatory Affairs, Sanofi
- Medical Products: Operationalizing FDA’s New Consistent Communications Guidance Document
FDA’s recently issued Consistent Communications Guidance presents new opportunities for drug and device manufacturers, alike, to better inform healthcare professionals. But, these new opportunities are accompanied by new risks. The panelists will share strategies that they have implemented over the last year to operationalize the guidance in a manner that: takes advantage of the new opportunities, ensures that the guidance is consistently implemented across marketing teams, and minimizes risk.
Sheetal Patel, Head, Regulatory Advertising and Promotion, US Pharmaceuticals Group Healthcare Compliance, Johnson & Johnson
Eric Rogers, Global Head, Regulatory and Development Law, Alcon Laboratories, Inc.
Moderated by Lisa M. Dwyer, Partner, King & Spalding LLP
- FDA’s Guidance on Electronic Submissions of Promotional Materials
Join members of FDA’s Office of Prescription Drug Promotion (OPDP) as they provide in-depth insight and advice regarding the submission of promotional materials in electronic Common Technical Document (eCTD) format to OPDP. FDA will provide a brief overview of the Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs draft guidance, review selected portions of the guidance in detail, and provide helpful technical tips for successfully submitting promotional materials to FDA as described in the guidance.
Kemi Asante, Health Science Policy Analyst, Office of Prescription Drug Promotion, CDER, FDA
Jason Cober, Project Management Team Leader, Office of Prescription Drug Promotion, CDER, FDA
Luncheon and Facilitated Table Topic Discussions
These facilitated, informal discussions provide an ideal way to engage with colleagues, gain new information, and share best practices on an advertising and promotion topic. Attendees have the option to choose from one of the 15+ topics or enjoy open-seating during lunch.
Real World Evidence: Data Requirements, Utilization, and Presentation
With the new Communications with Payors and Consistent with Labeling guidance documents, as well as the proliferation of big data, Real World Evidence has become increasingly prominent—relied upon by payers and potentially, in the future, by health care professionals. However, real world evidence is not clinical trial data. How should we evaluate real world evidence? How strong is the data? How strong should the data be before using it in a promotional context or as the basis for a value based contract? The session will explore the use of real world evidence and provide a framework through which to view the apt utilization of the evidence.
Joy J. Liu, VP, Commercial and Regulatory Legal, Vertex Pharmaceuticals, Inc., and Secretary and General Counsel, FDLI Board of Directors
Meredith Manning, Partner, Hogan Lovells US LLP
Kirke Weaver, Vice President, Office of General Counsel, Merck & Co., Inc.
Moderated by Michael Labson, Partner, Covington & Burling LLP
Scientific Exchange and the First Amendment
FDA has long recognized that medical product manufacturers have the right to engage in scientific exchange, including communications about products in development and unapproved or uncleared uses of marketed products, but it is not clearly delineated when a communication qualifies as scientific exchange or is subject to regulation as advertising or labeling. In the wake of recent First Amendment decisions, important questions have arisen regarding the balance between the agency’s regulatory authority over manufacturer communications and the public health interest in ensuring access to accurate and reliable scientific and medical information about medical products. In this panel, we will discuss the current status of FDA’s consideration of First Amendment issues and scientific exchange, focusing on areas of consensus among stakeholders and outlining a path forward for the new agency leadership to consider, given FDA’s broad authority and critical legal limitations.
Kelly F. Goldberg, Vice President, Law/Senior Counsel for Biopharmaceutical Regulation, PhRMA
Coleen Klasmeier, Partner, Sidley Austin LLP
Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Moderated by Kellie B. Combs, Partner, Ropes & Gray LLP
2018 Planning Committee
Dale Cooke, PhillyCooke Consulting
Kellie Combs, Ropes & Gray LLP
Lisa Dwyer, King & Spalding
Mark Gaydos, Sanofi
Kelly Goldberg, PhRMA
Wayne Pines, APCO Worldwide
Jennifer Romanski, Porzio Bromberg & Newman PC
Lucy Rose, Lucy Rose & Associates LLC
Paul Savidge, Spark Therapeutics Inc.
Ellen Schumacher, Bristol-Myers Squibb Company
Continuing Legal Education
Location and Overnight Accommodations
Renaissance Downtown Hotel
999 Ninth St NW
Washington, DC 20001
Driving, Parking, and Public Transportation
Renaissance Downtown Hotel is a short walk from Metro Center and Gallery Place/Chinatown metro stations. Onsite parking fee is $35 a day, valet parking is $45. Parking garages are also available nearby.