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Tuesday, June 28 • 4:00pm - 5:15pm
#261: Marketing After Amarin and Pacira

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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 Amendment rights of individuals and corporations. Kamp’s professional experience includes 10 years with the Washington, DC, office of the American Association of... Read More →

Speakers
avatar for Kellie Combs

Kellie Combs

Counsel, Ropes & Gray LLP
Kellie Combs is Counsel 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 as co-counsel to the Medical Information Working Group, represented Pacira in its litigation against FDA, and has extensive experience handling matters implicating... 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, Hyman, Phelps & McNamara, PC
Alexander J. Varond works on medical device and drug development, 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 issues. Mr. Varond also supports ongoing litigation efforts and performs due diligence for corporate transactions.


Tuesday June 28, 2016 4:00pm - 5:15pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA