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Regulatory Focus™ > News Articles > Walking the Digital Tight-Rope

Walking the Digital Tight-Rope

Posted 05 November 2015 | By Linda PollitzMoulakshi Roychowdhury, PharmD, JD

Walking the Digital Tight-Rope

On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media. Most likely, you are currently reading this on your iPad, smart phone or computer screen as are the majority of people seeking information in this digital-age. To align with current user-practices, Regulatory Focus magazine moved to a completely digital format in 2012. Along the same vein, to ensure communications are effective and efficiently reaching target audiences, pharmaceutical and medical device companies have no choice but to step into the foray of internet-promotion and social media.

As regulatory professionals, we are faced with a conundrum: providing guidance to companies on how to disseminate product communications which are not only truthful and not misleading, but also warn sufficiently, in media with considerable space limitations. To further complicate matters, we are dealing with a form of media which is continuously evolving, thus preventing us from creating strict standards (which would rapidly become antiquated), and instead we are having to continuously educate ourselves on new technology and develop dynamic principles.

To the US Food and Drug Administration's (FDA) and specifically, the Office of Prescription Drug Promotion's (OPDP), credit, tremendous effort has been put into research and providing guidance on how to navigate this terrain in the past couple years. Starting with the revisions to Form FDA 2253 (the form utilized to submit promotional materials to OPDP), in December 2013, to include codes for the world wide web (www) and social media, OPDP has issued a number of guidances to steer the industry in a direction that supports public health.

This collection of articles addresses the industry's digestion of these guidances in "FDA Social Media Guidance – Lessons Learned from the Comment Period." Furthermore, "The Evolving Approach of Presenting Risk Information to Consumers" highlights the output of OPDP's research and how they are impacting industry's interpretation of regulations for product communications to consumers, particularly via social media. Also to OPDP's credit, the office has been quick to put the industry on notice in situations where there may be expansive impact on public health, as evidenced by an infamous enforcement letter which will forever be known as the "Kim Kardashian" letter (see "Celebrity Endorsements – Lights, Camera, Enforcement Action?").

It is abundantly clear that as an industry, we are only at the advent of walking the digital tight-rope, and there is overwhelming interest in determining how to navigate moving forward. This collection of articles aims to give the readers a snap-shot of the current regulatory interpretations for pharmaceutical and medical device advertising and promotion (see listing of articles below). Ultimately, the question for us as regulatory professionals remains:  how do we strike a balance between being completely transparent while still delivering simple, concise, consumer-friendly messages?

We hope you enjoy this collection of articles. Your comments are welcome.

Linda Pollitz
Director of Regulatory Affairs, Advertising and Promotional Labeling
Alkermes Inc.

Moulakshi Roychowdhury, PharmD, JD
Senior Director, Regulatory Affairs – Advertising and Labeling 


Table of Contents

Stories From the Promotional Review Battlefront

By Jill Charbonneau

This article shares advertising and promotion experiences and presents strategies to improve a team's performance.

Celebrity Endorsements Lights, Camera, Enforcement Action?

By Georgina Lee, PharmD

This article discusses the use of celebrity endorsements to promote a disease state or a pharmaceutical drug.

The Evolving Approach of Presenting Risk Information to Consumers

By Richard Lem, PharmD

This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency.

FDA Social Media Guidance - Lessons Learned from the Comment Period

By Linda Pollitz

This article reviews and summarizes public comments on FDA's two draft social media guidance documents.

Case Study: Regulatory Advertising and Promotion from a Fellow's Perspective

By John Riehl

This article discusses three components of Purdue's Regulatory Pharmaceutical Fellowship from a current fellow's perspective followed by a candid interview with Riehl.

Evolution of Advertising and Promotion Review Systems

By Bill Robinson and Linda Pollitz, RAC

This article addresses the evolution of review systems used for advertising and promotion materials.

Prescription Drug Advertising versus Non-Advertising Promotion in China: Contrasting Regulation

By Denise Sanchez

This article discusses the contrasts between regulatory oversight of prescription drug advertising and non-advertising promotion in China.

Social Media: Changing the Rules for the Regulatory Professional

By Kelli L. Tanzella, PhD

This article discusses social media's role in changing the regulatory landscape and how the regulatory professional must evolve to ensure compliance with FDA requirements specific to the medical device field.


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