BIOTECHNOLOGY 2013 - The Future of Off-Label Marketing After the Caronia Decision

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Category BIOTECHNOLOGY 2013

Deadline: June 18, 2013 | Date: June 18, 2013

Venue/Country: Online, U.S.A

Updated: 2013-05-03 18:03:42 (GMT+9)

Call For Papers - CFP

Over the past decade, the FDA and the Department of Justice have aggressively prosecuted -- both criminally and civilly -- pharmaceutical firms for promoting their drugs for off-legal uses. In the process, the Federal Government has recouped billions of dollars from drug firms under the False Claims Act in connection with allegedly illegal off-labeled promotion. However, in December 2012, in a surprising-to-some decision, the United States Court of Appeals for the Second Circuit reversed the conviction of a former sales representative that had been based on truthful statements involving off-label promotions of an approved drug. In vacating the conviction of Alfred Caronia, the court found that his truthful statements regarding off-label uses of Xyrem were protected by First Amendment of the United States Constitution.

For some, the Caronia decision may be seen as a vindication of the right to truthfully promote all pharmaceuticals off-label indications. For the Justice Department and FDA, statements since the decision are that they regard the decision as “business as usual” relative to enforcing the agency’s bar on off-label marketing.

In this webinar, we will explore the implications of the Caronia decision and what it may mean for those that might be inclined to take advantage of its apparent endorsement of a First Amendment right to off-label promotion. We will review the case in detail and try to understand why the Second Circuit reached its decision and seek to establish reasonable parameters as to what regulated industry, which also includes medical device companies and potentially the dietary supplement firms, can or cannot do in the wake of the Caronia decision. In doing so, we also will review some of the fundamental principles that have guided off-label promotion in the past, including guidance documents from FDA on the dissemination off-label promotion or materials and responding to unsolicited requests for information on off-label uses, including on social media.

Who Will Benefit:

Anyone involved in the creation and review of marketing materials at companies regulated by FDA should be aware of the potential impacts of the Caronia decision. Thus, we recommend that executives in the highest levels of companies participate. In particular, representatives from the following departments should find the webinar beneficial:

Sales

Marketing

Compliance

Legal

Regulatory Affairs

Medical Affairs

Clinical

Corporate Communications

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-60 Minutes Live Presentation

- Certificate of Attendance

About Speaker

Michael Swit has been addressing critical FDA legal and regulatory issues since 1984. Before recently joining Duane Morris LLP as a Special Counsel in its San Diego office, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA regulatory consulting firm headquartered in Washington, D.C., where he developed and ensured execution of a broad array of regulatory and other strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food, cosmetic, and dietary supplement industries.

Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA.

Speaker : Michael Swit

Product ID : F62304

Schedule Date :

Tuesday, June 18, 2013

duration : 01:00 to 02:00 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=50&productKey=237