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Wednesday, June 27 • 2:00pm - 3:00pm
#372: AdPromo: Assessing Risk in the Current Regulatory Environment

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-669-L04-P; CME 1.00; IACET 1.00; RN 1.00

The interpretation and application of advertising and promotion regulations continue to evolve under 21st Century Cures, new customers and sources of data, and new FDA guidance. The dearth of enforcement letters can imply 'anything goes' but DOJ/False Claims investigations and settlements, CIAs, etc., suggest otherwise. FDA and other government enforcement trends will be discussed, including a review of cases involving whistle blowers , DOJ, False Claims Act, Lanham Act and CIAs. In this “point – counterpoint” session, attendees will be equipped with a greater understanding of the environment which will contribute to better decision making when assessing advertising and promotional activities and materials and the potential unintended implications today.

Learning Objectives

Evaluate the regulatory, legal, and compliance environment for prescription drug and medical device advertising and promotion in the context of First Amendment case law; Apply key factors to making well-informed assessments of risk and communication of impact in proposed promotion and advertising tactics and promotional material.

Chair

Mark Gaydos

Speaker

Panelist
Erin Baxendale, JD

Panelist
Alan G. Minsk, JD



Speakers
avatar for Erin Baxendale

Erin Baxendale

Partner, Sidley Austin LLP
Torrey Cope advises clients on a wide range of FDA regulatory issues. He is an experienced regulatory lawyer who regularly works on legal matters involving good clinical practice (GCP) and other requirements for clinical trials, marketing authorization, promotion, good manufacturing... Read More →
avatar for Torrey Cope

Torrey Cope

Partner, Sidley Austin LLP
Torrey Cope advises clients on a wide range of FDA regulatory issues. He is an experienced regulatory lawyer who regularly works on legal matters involving good clinical practice (GCP) and other requirements for clinical trials, marketing authorization, promotion, good manufacturing... Read More →
avatar for Mark Gaydos

Mark Gaydos

VP, NA General Medicines/US Advertising and Promotion, Global Regulatory Affairs, Sanofi
Mark is VP & Head, North America Gen. Medicines & Established Products, as well as US Advertising & Promotion, within Sanofi's Global Regulatory Affairs. In this role, he is accountable for regulatory leadership and strategy for investigational and marketed products and oversees the... 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 →


Wednesday June 27, 2018 2:00pm - 3:00pm
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA