The FDA's New "Bad Ad Program": Be Ready for Enforcement

Presented by Arnold Friede

Recorded On: Tuesday, August 10, 2010

Duration: 90 minutes

PURCHASE:

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RECORDING HIGHLIGHTS:

The FDA recently unveiled an outreach program to educate healthcare professionals about the role they can play in guarding against violative or misleading prescription drug promotions. This effort, dubbed the “Bad Ad Program,” encourages physicians to report questionable promotions, a move that effectively deputizes doctors as FDA investigators.

In this 90-minute audio conference, industry advertising and promotion expert Arnold Friede will examine the “Bad Ad Program” in detail. He will discuss the compliance and enforcement implications of the program, as well as its practical effect on the relationship between detailer and doctor. The audio conference will also examine approaches that companies might employ to minimize this new risk and how to build on existing compliance programs to address it.

Learning Points and Questions To Be Answered:

What is the new FDA “Bad Ad Program”?
How does it work?
What is the relationship between the “Bad Ad Program” and existing DDMAC compliance and enforcement actions?
What are the implications of the “Bad Ad Program” in terms of the relationship between detailer and doctor?
What new risks does the “Bad Ad Program” create?
What strategies and tactics can companies employ to minimize these risks?

Attendees Who Will Benefit From This Audio Conference Include:

Compliance, legal, and regulatory affairs professionals
Medical Science Liaisons
Sales personnel
Risk Management professionals
Industry consultants and service providers
Outside counsel who specialize in advising companies on advertising and promotion compliance
General counsel
Pharmaceutical and biotech firm professionals
Medical products legal professionals

YOUR EXPERT(S):

Arnold Friede
Arnold Friede is the principal in Arnold I. Friede & Associates, a firm specializing in FDA-related legal and regulatory matters. Arnold is a widely respected food and drug law counselor and advocate with significant advertising law, health care law, First Amendment, environmental, and commercial and transactional experience. He has a long history of direct involvement in successfully representing clients in FDA-regulated matters beginning as an associate chief counsel in the FDA's Office of Chief Counsel, as well as a broad spectrum of senior in-house legal experience across multiple FDA-regulated industries. Mr. Friede has been involved for nearly 35 years in a broad range of FDA and other agency-regulated businesses, including the life sciences, such as pharmaceutical and biotech, medical device, medical information, disease management, and over-the-counter drugs, as well as in the food, cosmetic, chemical and other industries.