Off-Label Communication: Top Tips for Compliance


9:30 a.m. – 10:00 a.m.


10:00 a.m. – 10:15 a.m.

Welcoming Remarks

Nikki Reeves, Partner, King & Spalding LLP

10:15 a.m. – 11:30 a.m.

FDA Guidance & Impact on Regulatory & Quality Professionals

FDA’s recently issued Consistent Communications Guidance presents new opportunities for medical product manufacturers to better inform healthcare professionals. But, these new opportunities are accompanied by new risks. The panelists will share strategies 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.

Lisa M. Dwyer, Partner, King & Spalding LLP

Joshua Eizen, Senior Counsel, U.S. Chief Compliance Officer, Actellion

Kelly Goldberg, Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA

John Murphy, Deputy General Counsel, BIO

11:30 a.m. – 11:45 a.m.

Networking Break

11:45 a.m. – 12:30 p.m.

Litigation Affecting Regulatory & Quality Professionals

DOJ and FDA have suffered several setbacks in the wake of recent First Amendment decisions, which have hindered their efforts to prosecute off-label promotion of drugs and devices. This session will explore the current landscape of First Amendment and off-label promotion issues, including recent cases and their ramifications for sales and marketing, clinical trials, and communications about drugs and devices regarding uses that FDA may consider to be off-label.

Jeffrey S. Bucholtz, Partner, King & Spalding LLP

Don Bunnin, Executive Director, Senior Counsel - Litigation & Commercial Eye Care, Allergan

Sean Flynn, Associate General Counsel and Chief Compliance Officer, ABIOMED, Inc.

John Richter, Partner, King & Spalding LLP

12:30 p.m. – 1:30 p.m.

Luncheon Address

Ethan Davis, Deputy Assistant Attorney General, Consumer Protection Branch, DOJ

1:30 p.m. – 2:15 p.m.

Hypothetical Off-Label Communication Cases

Recent FDA guidance has raised new questions regarding how to assess the risks associated with communications to patients, providers, payors, and similar entities. Using hypothetical but common real-world scenarios, this session will provide an overview of the risks that drug and device manufacturers face with respect to communications regarding uses that FDA may consider to be off-label. The session will explore these scenarios within the context of recent off-label promotion cases, and will engage audience members as we walk through the difficult questions that often arise when manufacturers communicate certain information about their products to third parties.

Katlin Backfield, Attorney and Consultant, Backfield, PLLC; former Associate Chief Counsel for Drugs, FDA

Carolyn Bruguera, General Counsel,  MDMA

Pete Leininger, Counsel, King & Spalding LLP; former Associate Chief Counsel for Enforcement at FDA

2:15 p.m. – 3:00 p.m.

Drug & Device Manufacturers Communication with Payors, Formulary Committees & Similar Entities

FDA’s recently issued guidance on the proactive dissemination of healthcare economic information (HCEI) by drug and device manufacturers to payors and formulary committees provides an opportunity for manufacturers to communicate additional economic information to these entities about approved drugs and investigational drugs and devices that are not yet approved or cleared for any use. This session will analyze changes made by the guidance and how those changes will impact the industry. In addition, the session will discuss strategies for operationalizing proactive communications to payors and delivering information that complies with the recently-issued guidance while also meeting the needs of payors and similar entities.

David Bloch, Principal Legal Counsel, Medtronic

Nikki Reeves, Partner, King & Spalding LLP

Paul Savidge, General Counsel, Spark Therapeutics

3:00 p.m. – 3:15 p.m.

Networking Break

3:15 p.m. – 4:15 p.m.

From Social Media to Soap Operas: Exploring New and Novel Advertising and Promotion Tactics in the Current Landscape

This session will explore the current advertising and promotion landscape established by FDA and FTC and discuss how the life sciences industry is beginning to utilize advertising and promotion strategies that go beyond traditional approaches.  We will also highlight new and novel marketing tactics – from emerging social media platforms to product placement in a soap opera, from engaging influencers to detailing state judges, from reality TV sponsorship to pop up shops.  How can legal, regulatory and compliance functions effectively assess and guide the creativity of commercial teams in promotional efforts?

Heather Banuelos, Counsel, King & Spalding LLP

Gillian M. Russell, Counsel, King & Spalding LLP

4:15 p.m. – 4:30 p.m.

Networking Break

4:30 p.m. – 5:00 p.m.

Q&A with Audience

5:00 p.m.

Adjournment & Reception




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