FDAnews Announces — Drug Promotion Enforcement Letters: 19 Buzzwords OPDP Keys On During Promotional Reviews Webinar, Oct. 29, 2014

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When just one wrong word can derail an entire drug marketing campaign, manufacturers need to know what that one word is. In 90 highly informative minutes, Washington lawyer Julie Tibbetts shows just what the FDA is looking for in branding, advertising and promotion.

Drug Promotion Enforcement Letters:
19 Buzzwords OPDP Keys On During Promotional Reviews
**FDAnews Webinar**
Oct. 29, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http:// http://www.fdanews.com/DrugPromotionEnforcementLetters

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

An analysis of OPDP enforcement letters over the past 12 months clearly shows 19 words and phrases manufacturers shouldn’t use in prescription drug advertising. But, these words or phrases won’t be 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.

Washington lawyer Julie Tibbetts has combed through recent enforcement letters and drawn up the buzzwords and study designs.

In over 90 highly informative minutes, Ms. Tibbetts shows just what the FDA is looking for in branding, advertising and promotion. Using actual enforcement-letter texts to back up her presentation, she identifies current trends and shares best practices to help attendees avoid receiving such a letter. Attendees will 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 the 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

Meet the Presenter:
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.

Who Will Benefit:

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

Webinar Details:
Drug Promotion Enforcement Letters:
19 Buzzwords OPDP Keys On During Promotional Reviews
**FDAnews Webinar**
Oct. 29, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http:// http://www.fdanews.com/DrugPromotionEnforcementLetters

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http:// http://www.fdanews.com/DrugPromotionEnforcementLetters
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.

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Michelle Butler
FDANEWS
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