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Monday, June 27
 

8:30am EDT

#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-526-L01-P; CME 1.25; IACET 1.25; RN 1.25

In vitro diagnostic devices are important tools intended for use in the diagnosis of disease or other conditions, including a determination of the state of health. Based on a diagnosis, it seems reasonable for a company to recommend an appropriate prescription drug treatment. This session reviews the basics of advertising and promotion for devices and prescription drugs in the context of intended use and approved indications. Taking the substantial evidence requirements and recent 1st Amendment challenges into consideration, the panelists will provide a systematic assessment of scenarios when company may or may not co-promote or recommend a prescription treatment based on a diagnostic outcome.

Learning Objectives

Identify valuable insights into the regulatory and legal boundaries of advertising and promotion of a device with a prescription drug when these tactics go beyond the approved intended use/indication, and when this may be viewed as an unapproved new combination device/drug product.

Chair

Kimberly Belsky, MS

Speaker

Panelist
Alan G. Minsk, JD

Panelist
Minnie Baylor-Henry, JD, RPh



Chair
avatar for Kimberly Belsky

Kimberly Belsky

Senior Director, Regulatory Affairs, Regulatory Intelligence, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals... Read More →

Speakers
avatar for Minnie Baylor-Henry

Minnie Baylor-Henry

President, B-Henry & Associates
President of B-Henry & Associates, a consulting firm focused on providing regulatory and compliance strategy services to life sciences companies. Prior to assuming her current role in early 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s... Read More →
avatar for Alan Minsk

Alan Minsk

Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP
Alan G. Minsk is a partner in the Food and Drug and Government and Regulatory Practices. Mr. Minsk was recognized in chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv-Mkting, Forum
 
Tuesday, June 28
 

10:30am EDT

#213: FDA Enforcement Update: Advertising and Promotion
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-527-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA enforcement actions and policy guidances need to be understood by every company because they reflect FDA's priorities and concerns in regulating advertising and promotion. In this forum, FDA representatives will examine the latest agency enforcement actions and policies and what they mean.

Learning Objectives

Describe the latest FDA enforcement actions and policy initiatives in the area of advertising and promotion; Explain what the enforcement actions reflect about FDA policies and priorities.

Chair

Philomena McArthur, JD

Speaker

CDER Perspective
Thomas W. Abrams

CBER Perspective
Lisa L. Stockbridge, PhD



Chair
avatar for Philomena McArthur

Philomena McArthur

Vice President Global Policies, Procedures & Training, Healthcare Compliance & P, Johnson & Johnson International
Philomena McArthur's diversified experience spans 25 yrs. She currently oversees the Regulatory Advertising & Promotion Dept. in Health Care Compliance supporting the Janssen Pharmaceutical companies of Johnson & Johnson, for whom she has worked for 10 yrs. Philomena has held a variety... Read More →

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. He joined FDA as a reviewer in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical... Read More →
avatar for Lisa Stockbridge

Lisa Stockbridge

Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA
Dr. Stockbridge is chief of the Advertising and Promotional Labeling Branch in CBER’s Office of Compliance and Biologics Quality. Her team reviews promotional labeling and advertising, proprietary names, and product labeling. With over 15 years of experience in both CDER’s DDMAC... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv/Mkting, Forum

2:00pm EDT

#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-522-L04-P; CME 1.25; IACET 1.25; RN 1.25

The legislative and regulatory landscapes for expanded access to investigational therapies are evolving due in part to public attention. This session will examine strategies proposed by stakeholders to address ethical, regulatory, and policy considerations.

Learning Objectives

Recognize FDA requirements for expanded access and the current regulatory, political, and social environment; Identify challenges faced by stakeholders from ethical, regulatory, and policy perspectives; Describe industry best practices for managing expanded access programs.

Chair

Kim M. Quaintance-Lunn

Speaker

Is There a Better Way? An Industry Perspective
Sandra A. Morris, PhD, PMP

The Ethics of Compassionate Use
Alison Bateman-House



Chair
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, Regulatory Affairs Americas, Bayer U.S. LLC, United States
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, Regulatory Affairs Americas, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy and... Read More →

Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Langone Health, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair, with Arthur Caplan PhD, of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies... Read More →
avatar for Sandra Morris

Sandra Morris

Vice President, Strategy Realization, Johnson & Johnson
Dr. Morris is currently VP, Strategy Realization for the J&J CMO. Prior to joining J&J, Dr. Morris spent 18 years at Merck where she was VP, Global Project Management. Dr. Morris received her PhD in Organic Chemistry and completed postdoctoral research in biochemistry.


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Session

2:00pm EDT

#238: Prescription Drug Marketing Regulatory Primer
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-528-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will provide a basic introduction to the regulation of prescription drug advertising and promotion. It will cover such important information as fair balance, required claim support, comparative claims, preapproval activities, and medical conventions.

Learning Objectives

Discuss important environmental forces and agencies impacting the regulation of prescription drug promotion; Apply advertising and promotional regulations to advertising/marketing materials; Explain the importance of reviewing FDA regulatory letters as they apply to these regulatory decisions.

Chair

Lucy Rose, MBA

Speaker

FDA Perspective
Thomas W. Abrams



Chair
avatar for Lucy Rose

Lucy Rose

President, Lucy Rose and Associates, LLC

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. He joined FDA as a reviewer in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv/Mkting, Session

4:00pm EDT

#261: Marketing After Amarin and Pacira
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-529-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA regulation of off-label communications by industry sponsors has been under extraordinary scrutiny the past several years, especially since the Supreme Court decision in IMS v. Sorrell and the federal appeals court decision in US v. Caronia. The issue came to a head in the federal district court in New York city last summer that resulted in the decision against FDA in Amarin v. FDA and a similar challenge by Pacira Pharma against FDA. Meanwhile, the FDA has promised regulatory guidances on aspects of off-label communication policy and the US House of Representatives has passed related legislation. This session will review and assess the regulatory importance of these events, including any late breaking news from Congress, the Courts, and the FDA.

Learning Objectives

Identify many of the details of the Amarin and Pacira cases including how they may effect ongoing decision making in Congress, the courts, and FDA; Describe existing and emerging guidance from FDA and how it may change regulatory policy.

Chair

John Kamp

Speaker

Life After Amarin and Pacira: Understanding Off-Label Promotion in 2016
Alexander Varond, JD

Panelist
Jeffrey K. Francer

Panelist
Kellie B. Combs, JD



Chair
avatar for John Kamp

John Kamp

Executive Director, Coalition For Healthcare Communication
Dr. John F. Kamp is Executive Director of the Coalition for Healthcare Communication, a medical marketing trade association with offices in New York City and Washington, DC. He is also Consulting Counsel with the law firm Wiley Rein LLP, and is a widely respected advocate for First... Read More →

Speakers
avatar for Kellie Combs

Kellie Combs

Partner, Ropes & Gray LLP
Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She serves... Read More →
avatar for Jeffrey Francer

Jeffrey Francer

Vice President and Senior Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jeff Francer is Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he provides advice and advocacy to the Association and its member companies on FDA regulatory and policy matters.
avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv-Mkting, Session