Food & Drug Regulation

OPDP Enforcement Actions: How to Be Prepared for the Year Ahead

Presented by Joy Liu
Recorded On: Thursday, January 24, 2013
Duration: 90 minutes
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By Phone: 1-800-677-3789

For the marketing, legal, and regulatory personnel of pharmaceutical companies, complying with FDA regulations and guidance concerning drug advertising and promotion can be a complex task fraught with significant risks. You must have a thorough understanding of how the FDA interprets and applies advertising and promotion regulations – and put your knowledge to action – to avoid enforcement actions such as Warning Letters and Untitled Letters.

Make sure you are prepared. Attend our brand new webinar taking place on January 24th.

During this 90-minute live event, you’ll gain a real-world best practice guidance and comprehensive understanding of the enforcement actions taken by the Office of Prescription Drug Promotion (OPDP, formerly known as DDMAC) in the past year.

Your expert speaker, Joy Liu, a partner at the law firm of Ropes & Gray, will also provide you with themes and trends that can be identified from Warning and Untitled Letters and as well as implications for 2013.  

Following the presentation, you’ll have the opportunity to ask questions of Ms. Liu during the live Q&A portion of the webinar.

Questions that will be answered:

  • How does OPDP identify promotional activities that become the subject of enforcement action?
  • How do OPDP's 2012 enforcement letters compare against letters from prior years?
  • What were the most frequent violations cited by OPDP in 2012 enforcement letters?
  • What themes and trends can be gleaned from OPDP's 2012 enforcement actions?
  • What were the most noteworthy OPDP enforcement letters in 2012?
  • What can you expect in 2013 and how should you prepare?

Who Should Attend:

  • Anyone involved in promotion of FDA-regulated prescription drug advertising and promotion, including:
    • Regulatory affairs professionals
    • Marketing professionals
    • Legal counsel
    • Industry consultants
Joy Liu
Joy Liu represents large pharmaceutical, biotechnology, and medical device companies on a broad range of FDA regulatory issues. Joy has developed a particular expertise in counseling companies on advertising and promotion issues, and has, in that respect, served as the legal reviewer on promotional review committees for both large and small pharmaceutical companies and helped to advise the Medical Information Working Group, a coalition of more than a dozen pharmaceutical and device manufacturers interested in seeking clarity in government policies governing promotional practices.