Drug Promotion Enforcement Letters

Drug Promotion Enforcement Letters - Webinar CD/Transcript

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Drug Promotion Enforcement Letters: 19 Buzzwords OPDP Keys On During Promotional Reviews

When just one wrong word can derail an entire drug marketing campaign, you need to know what that one word is. Get the red flags out of your marketing messages.

An analysis of OPDP enforcement letters clearly shows 19 words and phrases you shouldn’t use in your prescription drug advertising. But, you won’t find these words or phrases spelled out on the FDA website – or anywhere, for that matter.

Plus, there’s a variety of study designs that failed OPDP’s “substantial evidence” threshold to support safety and efficacy claims.  Could you be using these in your promotions right now?

Washington lawyer Julie Tibbets has combed through recent enforcement letters and drawn up the buzzwords and study designs. Now she’s ready to share it – with YOU.

In over 90 highly informative minutes, Ms. Tibbets shows just what the FDA is looking for in your branding, advertising and promotion. Using actual enforcement-letter texts to back up her presentation, she identifies current trends and shares best practices to help you avoid receiving such a letter. You’ll discover –

  • The 19 “buzzwords” that surface most often in enforcement letters from the FDA Office of Prescription Drug Promotion (OPDP) …
  • Study designs that failed OPDP’s “substantial evidence” threshold to support safety and efficacy claims …
  • The 10 best practices that lower your risk of receiving an OPDP letter …
  • Key stats – the number and types of letters from OPDP over the past few years …
  • Case studies – examination letters that highlight OPDP’s focus on risk information and proper claims substantiation
  • And much more!

You’re sure to think of questions during Ms. Tibbets’ presentation. No need to save them up though. Simply email them in, in real time, for full responses by the time the session ends.

It’d be well worth your time and trouble to fly to Washington for regulatory insights such as these. Luckily there’s no need to incur the expense or hassle. This session comes to you, via the screen sitting on your own desktop.

Consider signing up if your job title includes –

  • Advertising and promotions professionals
  • Regulatory affairs and compliance officers
  • General/corporate counsel
  • Medical affairs professionals
  • Strategic planning and business development staff

Julie Tibbets is a partner in the Food, Drug & Device/FDA Group at Alston & Bird LLP. Her practice focuses on regulatory risks associated with product positioning – branding, advertising and promotion – especially as they Rx drug and device labeling and advertising, sales training, interactions with health care professionals, continuing medical education, social media, Sunshine Act compliance and medical affairs. She was named a 2013 and 2014 FDA-practice "Rising Star" by Super Lawyers Magazine.