Promotion of FDA-Regulated Medical Products v
Foreword
I was pleased to learn that RAPS sought to update the 2013 publication FDA Requirements for Prescription Drug
Promotion by John Driscoll, and to learn that the FDA Practice at Mintz Levin had been asked to prepare the new edi-
tion. The new title, Promotion of FDA-Regulated Medical Products, indicates a clear expansion of scope, and the author
team went to great lengths to cover a broad range of products, beyond prescription drugs. This is so important given
the current state of technology development and the proliferation of combination products, cellular and biological
therapies, and complex medical devices. The broader scope was approached in a methodical and thorough way. The
legal and regulatory framework for promotional requirements is a complex area for a regulatory professional. The chal-
lenges include multiple sources of jurisdictional oversight, the evolving landscape of sales and marketing techniques,
like social media, and the unique internal and external human interactions that happen in the promotional context.
These challenges often present complex issues as well as enforcement risks for noncompliance. This new comprehensive
guide will be a great addition to a regulatory professional’s library of resources.
As I reflect on the area of advertising and promotion over the last five years, it is surprising to realize the number
of changes that have occurred. The many updates made in this revision will serve as clear reminders to all regulatory
professionals and stakeholders involved with FDA-regulated product promotion that the requirements are evolving
and dynamic. Certainly, the legal and regulatory requirements should not be considered in a vacuum, as other factors
also influence the specifics around developing an effective promotional campaign, such as the forum and method for
marketing engagement, the clinical delivery system through which the medical product is used and the history of
enforcement in the specific area. While this revision was drafted by a team of lawyers who regularly practice in this
area, it is important to remember that this new edition, like the first, is a resource and should not be considered suffi-
cient legal or regulatory advice for a particular situation. It is critical to remember that regulatory professionals must
work with their medical and legal colleagues to understand the specific application of these requirements to their com-
pany’s particular products. Additionally, FDA professionals in OPDP, APLB and CDRH are highly valuable resources
that should be utilized, where appropriate.
This edition will feel very different to readers familiar with the first publication, as the Mintz author team signifi-
cantly reorganized the content and flow of issues to accommodate the rapidly changing requirements in this area. Chapter
1 lays out the full framework of FDA’s oversight functional offices and divisions, like the Office of Prescription Drug
Promotion (OPDP), which used to be the Division of Drug Marketing, Advertising, and Communication (DDMAC).
Chapter 1 also covers non-FDA oversight, such as the FTC and the independent organization, National Advertising
Division (NAD) of the BBB. Chapter 2 is a comprehensive resource that describes the labeling and advertising regulatory
framework and should be a must-read for all regulatory, sales and marketing professionals, and even corporate executives
and investment professionals. Chapter 3 rounds out Part I by addressing the distinct challenges of communications made
prior to product approval and the evolving landscape for off-label promotional prohibitions. Part II focuses on the differ-
ent rules that apply based on the promotional activity’s target audience. Chapter 4 lays out the specific requirements for
engaging with healthcare providers, and Chapter 5 tackles the issue of direct-to-consumer or patient medical product pro-
motion. Chapter 6 is a valuable reference given the increasing pressures to communicate product details with payers and
other sophisticated audiences and offers details on sharing Health Care Economic Information that were not included in
the first edition. Finally, Part III concludes this edition with the brief, but critical, Chapter 7, which highlights the vast
number of additional legal and regulatory requirements of which regulatory professionals should be aware and keep at
the forefront of their minds when considering the promotion of FDA-regulated medical products, such as transparency
reporting, fraud and abuse prohibitions and personal liability for noncompliance.
This book is a resource for anyone who touches the medical product promotion process. I highly encourage
organizations to have multiple copies available to a broader audience than just the core regulatory professionals. If
everyone working on a promotional campaign truly understands the framework as laid out in this edition, discussions
will be more productive, and compliance with requirements will become a natural part of the creative process needed
to promote FDA-regulated medical products.
A special thanks to RAPS and the Mintz Levin team for recognizing the need to update this important publica-
tion to reflect the vast number of changes in the area of medical product advertising and promotion.
Minnie Baylor-Henry, RPh, JD
President, B-Henry &Associates
(Former DDMAC Division Director-1995–99)
Foreword
I was pleased to learn that RAPS sought to update the 2013 publication FDA Requirements for Prescription Drug
Promotion by John Driscoll, and to learn that the FDA Practice at Mintz Levin had been asked to prepare the new edi-
tion. The new title, Promotion of FDA-Regulated Medical Products, indicates a clear expansion of scope, and the author
team went to great lengths to cover a broad range of products, beyond prescription drugs. This is so important given
the current state of technology development and the proliferation of combination products, cellular and biological
therapies, and complex medical devices. The broader scope was approached in a methodical and thorough way. The
legal and regulatory framework for promotional requirements is a complex area for a regulatory professional. The chal-
lenges include multiple sources of jurisdictional oversight, the evolving landscape of sales and marketing techniques,
like social media, and the unique internal and external human interactions that happen in the promotional context.
These challenges often present complex issues as well as enforcement risks for noncompliance. This new comprehensive
guide will be a great addition to a regulatory professional’s library of resources.
As I reflect on the area of advertising and promotion over the last five years, it is surprising to realize the number
of changes that have occurred. The many updates made in this revision will serve as clear reminders to all regulatory
professionals and stakeholders involved with FDA-regulated product promotion that the requirements are evolving
and dynamic. Certainly, the legal and regulatory requirements should not be considered in a vacuum, as other factors
also influence the specifics around developing an effective promotional campaign, such as the forum and method for
marketing engagement, the clinical delivery system through which the medical product is used and the history of
enforcement in the specific area. While this revision was drafted by a team of lawyers who regularly practice in this
area, it is important to remember that this new edition, like the first, is a resource and should not be considered suffi-
cient legal or regulatory advice for a particular situation. It is critical to remember that regulatory professionals must
work with their medical and legal colleagues to understand the specific application of these requirements to their com-
pany’s particular products. Additionally, FDA professionals in OPDP, APLB and CDRH are highly valuable resources
that should be utilized, where appropriate.
This edition will feel very different to readers familiar with the first publication, as the Mintz author team signifi-
cantly reorganized the content and flow of issues to accommodate the rapidly changing requirements in this area. Chapter
1 lays out the full framework of FDA’s oversight functional offices and divisions, like the Office of Prescription Drug
Promotion (OPDP), which used to be the Division of Drug Marketing, Advertising, and Communication (DDMAC).
Chapter 1 also covers non-FDA oversight, such as the FTC and the independent organization, National Advertising
Division (NAD) of the BBB. Chapter 2 is a comprehensive resource that describes the labeling and advertising regulatory
framework and should be a must-read for all regulatory, sales and marketing professionals, and even corporate executives
and investment professionals. Chapter 3 rounds out Part I by addressing the distinct challenges of communications made
prior to product approval and the evolving landscape for off-label promotional prohibitions. Part II focuses on the differ-
ent rules that apply based on the promotional activity’s target audience. Chapter 4 lays out the specific requirements for
engaging with healthcare providers, and Chapter 5 tackles the issue of direct-to-consumer or patient medical product pro-
motion. Chapter 6 is a valuable reference given the increasing pressures to communicate product details with payers and
other sophisticated audiences and offers details on sharing Health Care Economic Information that were not included in
the first edition. Finally, Part III concludes this edition with the brief, but critical, Chapter 7, which highlights the vast
number of additional legal and regulatory requirements of which regulatory professionals should be aware and keep at
the forefront of their minds when considering the promotion of FDA-regulated medical products, such as transparency
reporting, fraud and abuse prohibitions and personal liability for noncompliance.
This book is a resource for anyone who touches the medical product promotion process. I highly encourage
organizations to have multiple copies available to a broader audience than just the core regulatory professionals. If
everyone working on a promotional campaign truly understands the framework as laid out in this edition, discussions
will be more productive, and compliance with requirements will become a natural part of the creative process needed
to promote FDA-regulated medical products.
A special thanks to RAPS and the Mintz Levin team for recognizing the need to update this important publica-
tion to reflect the vast number of changes in the area of medical product advertising and promotion.
Minnie Baylor-Henry, RPh, JD
President, B-Henry &Associates
(Former DDMAC Division Director-1995–99)