It's the Message, Not the Medium

PDF Edition - It’s the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media

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Websites, medical meetings, television talk shows, trade shows . . . wherever your products are being mentioned, chances are good the FDA is watching and looking for violations of the rules covering promotions.

And with the agency cranking out three more social media guidances in 2014, you can expect even more challenges in the way the FDA evaluates promotions in the months ahead.

Now’s the time to take stock of your promotional review practices and see if they’re really covering all the places they need to – even those you might least expect. And what you can do about it if they’re not.

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 you take a hard look at your corporate communications and your formal and informal promotional activities, with an eye toward eliminating your risk of noncompliance.

With this report, you 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 you 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 your risk of noncompliance
  • How to develop procedures that will ensure you’ve got all your promotional materials under control

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

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.

  • 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

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