Healthy Skepticism Library item: 2704

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: media release

DDMAC Warning Letters, Avoid Regulatory Action, An audioconference
FDAnews 2005 Nov 1
http://www.fdanews.com/wbi/conferences/ddmac.html?s=8053&p=05ODML

Keywords:
FDA

Notes:

Ralph Faggotter’s Comments:

How to avoid a warning letter from the FDA.

Telling the truth about your products would probably work, but is unlikely to be the subject of this little discussion.

More likely the topic will be- ‘how to push the boundaries without getting caught’!

Full text:

An audioconference
Thursday, Nov. 10, 2005 • 11:00 a.m. – 12:30 p.m. EST

The FDA’s advertising division, DDMAC, has vowed to take “whatever action is necessary to stop misleading promotions.”

That’s why warning letters have skyrocketed 375 percent in the past 12 months.

You’re a prime target – even if you don’t do direct-to-consumer ads or patient testimonial videos. Your exhibit booth, journal ads, even your website could be just the type of promotion investigators are looking to cite.

Don’t risk devastating costs and bad publicity!

Register today!

This audioconference helps you develop citation-proof promotion strategies – and head off the FDA’s “whatever action is necessary” approach.

In 90 minutes, expert Keith Korenchuk walks you through five recent ads that triggered DDMAC warning letters. You’ll learn exactly where the advertisers went wrong – and how to avoid similar violations as you develop your own promotions.

Plus, you’ll learn how specific FDA enforcement activity translates into practical tips you can use to avoid your own exposure to regulatory action.

You’ll also learn:

* The most-frequently cited violations – and simple ways to avoid them * Specific language, font choices, colors or images that can trigger violations * Point-by-point assessments of what catches DDMAC’s attention and why * Why you must follow different rules for full-product versus reminder ads * PhRMA’s guiding principles for DTC ads and best practices for applying them

Meet Your Instructor
Keith M. Korenchuk is a partner with McGuireWoods LLP, where he provides leadership and guidance on compliance strategies for pharmaceutical, life science, medical device and healthcare organizations. He served as CEO of organizations focusing on pharmaceutical and healthcare sector compliance as well as co-chair of the health law department of a Top 100 American law firm. With an MPH from Harvard and a JD from the University of Virginia, Keith has been selected for inclusion in The Best Lawyers in America® since 2001.

Who Will Benefit
All personnel involved in prescription drug marketing and promotions, including:

* Compliance officers * Executive management * General/corporate counsel * Regulatory/legislative affairs professionals * Risk management specialist * Sales/marketing personnel

REGISTER NOW!