FDAnews Management Report — It’s the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media

Websites, medical meetings, television talk shows, trade shows, wherever products are being mentioned, chances are good the FDA is watching and looking for violations of the rules covering promotions. Now’s the time to take stock of all promotional review practices and see if they’re really covering all the places they need to.

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It's the Message Not the Medium

It's the Message Not the Medium

Falls Church, VA (PRWEB) April 28, 2014

It’s the Message, Not the Medium:
Managing FDA Promotional Compliance Beyond Traditional Media
**FDAnews Management Report**
http://www.fdanews.com/FDAPromotions

When the FDA reviews promotions it’s not looking at how the information is being distributed. Rather, it looks at what information is being distributed. The agency focuses on violations in four general areas that could occur in digital, nontraditional and, of course, standard promotions. The four areas are:

  •     Off-label promotion
  •     Misleading claims about efficacy or comparisons to other treatments
  •     Broadening of the allowed patient population or conditions of use; and
  •     Misleading media statements and press releases.

Within these four broad categories, the FDA is highlighting some underlying themes, like preapproval promotion. And it's taking a closer look at products that have a black box warning, and oncology products, which have a greater safety risk.

With these enforcement trends in mind, the new report It’s the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media will help manufacturers take a hard look at corporate communications and formal and informal promotional activities, with an eye toward eliminating the risk of noncompliance.

With this report, readers will learn:

  •     The four most common violations cited in FDA enforcement letters
  •     Specific promotional activities that some companies have engaged in on the web, via email, on TV and at trade shows that surprisingly drew FDA action
  •     How to develop a compliance checklist for a presentation, booth or other activity at a trade show
  •     How seemingly innocuous press releases can put manufacturers in hot water with both the FDA and the SEC
  •     How to develop a checklist for policies covering media, both paid and unscripted
  •     Steps to review corporate communications and formal and informal promotional activities, with an eye toward reducing the risk of noncompliance
  •     How to develop procedures that will ensure all promotional materials are under control

With It’s the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media, readers will gain a clear understanding of what the FDA is watching now and how to avoid enforcement action in the future.

Who Will Benefit

  •     Pharmaceutical and device company CEOs
  •     Corporate spokesmen
  •     Compliance officers
  •     Regulatory affairs officers
  •     Marketing and sales officers
  •     Advertising managers and staff
  •     Marketing managers and vendors
  •     Legal counsel

Meet the Authors
This report is largely drawn from comments made at an FDAnews webinar by Timothy Ayers and Michelle Axelrod, principals in the Porzio, Bromberg & Newman Life Sciences Compliance, Commercialization and Regulatory Counseling Department.
Ayers and Axelrod are also vice presidents of the firm’s subsidiary, Porzio Life Sciences, which offers marketing and sales compliance services to pharmaceutical, medical device and biotech companies.

Both are former in-house counsel and compliance leaders, with a broad range of experience in legal and compliance issues related to the development and commercialization of bio/pharma products and medical devices.

Management Report Details:
It’s the Message, Not the Medium:
Managing FDA Promotional Compliance Beyond Traditional Media
**FDAnews Management Report**
http://www.fdanews.com/FDAPromotions

Format: Print or PDF

Price: $397

Easy Ways to Order:
Online:     http://www.fdanews.com/FDAPromotions
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.