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.

Highlighted Topics:

  • 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

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Silver Sponsor

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Bronze Sponsor

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Exhibitor

Exhibitor

Call for Proposals

The Planning Committee thanks those who participated in the Call for Proposals that took place this spring. The broad input on topics from medical product industry stakeholders helps to ensure a timely and relevant program. Those who submitted a topic will be notified of the status of their proposal by the end of June.

Register

Industry & Firms

$1,449
  • +$600 for non-members

Non-Profit

$899
  • +$100 for non-members

Government

$899
  • +$100 for non-members

Academic

$899
  • +$100 for non-members

Student

$149
  • +$100 for non-members

Are You New to Advertising and Promotion?

Add the half-day training course, Introduction to Advertising and Promotion, to your conference registration to gain a comprehensive overview of the laws and regulations affecting the medical products industries and save $100 on the combined registration fees.

Sponsorship Opportunities

Sponsorship opportunities are available. Please let us know if you would like more information.

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.

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

Tuesday, September 26

At 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
Amy Comstock Rick
, President & CEO, Food and Drug Law Institute (FDLI)

9:00-10:00 AM 
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

10:00-10:45
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

10:45-11:15 AM 
Coffee Networking Break

11:15-12:00 PM 
Breakout Sessions

  • 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

12:00-12:15 PM 
Transition

12:15-1:30 PM 
Networking Lunch

1:30-1:45 PM 
Transition

1:45-2:45 PM 
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

2:45-3:00 PM 
Coffee and Networking Break

3:00–4:00 PM
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

4:00–5:00 PM
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 

5:00–6:30 PM
Networking Reception

Wednesday, September 27

At Renaissance Downtown Hotel
999 Ninth St NW, Washington, DC 20001

8:30–8:50 AM
Breakfast

8:50–9:00 AM
Welcome
Laura Brown, Director, Educational Programs, FDLI

9:00–10:00 AM
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

10:00–11:00 AM
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

11:00–11:30 AM
Coffee and Networking Break

11:30–12:15 PM
Breakout Sessions

  • 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.

    Joshua M. Eizen, Senior Counsel and Chief Compliance and Privacy Officer Actelion Pharmaceuticals, Inc.
    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

12:15–12:30 PM
Transition

12:30–1:30 PM
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.

1:30–1:45 PM
Transition

1:45–2:45 PM
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

2:45–3:45 PM
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

3:45 PM
Conference Adjournment

Planning Committee

Committee Co-Chairs

Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide
Lucy Rose, President, Lucy Rose & Associates, LLC

Committee Members

Katlin Backfield, Attorney and Consultant, Backfield PLLC
Kellie Combs, Partner, Ropes & Gray LLP 
Dale Cooke, President, PhillyCooke Consulting
Jim Czaban, Partner, DLA Piper LLP
Mark Gaydos, Vice President, North America General Medicine/US Advertising & Promotion, Global Regulatory Affairs, Sanofi
Matthew Hill, Vice President of Legal Affairs, Aclaris Therapeutics, Inc.
Coleen Klasmeier, Partner, Sidley Austin LLP 
Michael Labson, Partner, Covington & Burling LLP
Paul Savidge, US General Counsel, Spark Therapeutics, Inc.
Michele Sharp, Sr. Director, Global Regulatory Affairs – US, Eli Lilly and Company
Kristi Wolff, Partner, Kelley Drye & Warren LLP

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

10.0 credits for PA

Location and Overnight Accommodations

Conference Location

Renaissance Downtown Hotel
999 Ninth St NW
Washington, DC 20001

Overnight Accommodations

Rooms are available at a discounted rate of $319 a night through August 31 at the Renaissance Downtown Hotel. Online registration is required to qualify for the discounted rate.

Reserve Your Room

Business attire is recommended and some meeting rooms may have cooler temperatures.

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.

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.