The Caronia Court Decision and Off-Label Promotion: What Does this Mean for FDA's Regulation of Pharmaceutical and Medical Device Off-Label Marketing and Promotion?

Why Should You Attend:

This webinar is designed to provide attendees with an introduction to FDA’s regulation of product labels and labeling for prescription drugs and medical devices; and the off-label promotion of such products. The program will also offer attendees an overview of the risks associated with the off-label marketing and promotion of Rx drugs and medical devices including the prior issuing of Warning Letters, Untitled Letters and other enforcement activities by FDA’s Office of Prescription Drug Promotion or OPDP (formerly, the Division of Drug Marketing, Advertising and Communication or DDMAC).

Finally, the webinar will give participants an understanding of the Caronia decision, the legal framework behind it, its potential impact on FDA and Department of Justice enforcement policies, and how it might affect the off-label promotion of Rx drug products and medical devices.

Learning objectives:

• An introduction to the statutory and regulatory definitions of label and labeling generally.
• Gain an understanding of how FDA regulates pharmaceutical and medical device off-label marketing and promotion.
• Examples of FDA enforcement action prior to the Court’s decision in the Caronia case.
• A comprehensive overview of the Caronia case and the Court’s opinion.
• Explanation of the Court’s rationale for relying on the concept of constitutionally protected free speech in its decision.
• An understanding of the scope of the Court’s decision and whom it may affect.
• An analysis and predictions on how the Court’s decision in the Caronia case might impact the future of pharmaceutical and medical device off-label marketing and promotion.

Areas Covered in The Webinar:

• FDA’s regulation of product labels and labeling.
• The statutory and regulatory concepts of the product label and product labeling as applied to both pharmaceuticals and medical devices.
• Examples of FDA enforcement action against companies for off-label promotion prior to the Caronia case decision.
• The Department of Justice’s recent series of court cases and penalties for off-label promotion.
• Discussion of the Caronia case and explanation of the Court’s decision.
• Analysis of the potential impact that the decision in the Caronia Case might have on pharmaceutical and medical device companies moving forward and in the future.

Who Will Benefit:

• Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Officials, Insurers; Investment Analysts; Venture Capitalists
• Pharmaceutical and Drug Companies, Medical Device and Biotech Companies, Start-ups, Foreign Drug Companies and Device Manufacturers, Importers
• Marketing and Advertising Professionals and Experts; Consultants
• Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to domestic and international pharmaceutical, medical device and biotech companies on issues related to the U.S. Food and Drug Administration’s regulation of drug and medical device approvals, marketing, promotion, distribution and off-label promotion. He also advises these companies on the potential FDA regulatory risks associated with off-label promotion and the use of various disease / treatment claims on product labels. He frequently presents and has published on such topics.

Topic Background:

On December 3, 2012, the United States’ 2nd Circuit Court of Appeals handed down a decision in the Caronia case holding that certain types of off-label marketing and promotion is constitutionally protected free speech. If applied generally in the U.S. by the FDA, the court’s decision has a significant potential to impact both the pharmaceutical and medical devices industries; and their approach to the use of off-label promotion.

Attendees will develop an understanding of the Caronia decision, the legal framework behind it, its potential impact on FDA and Department of Justice enforcement policies, and how it might affect their own companies in the future. Finally, strategies for mitigating the potential risks associated with off-label promotion in this time of uncertainty will be provided.

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