Healthy Skepticism Library item: 15776

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

FDA
Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
: FDA 2009 May
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

Abstract:

TABLE OF CONTENTS
I. INTRODUCTION – 1
II. BACKGROUND – 2
A. LEGAL OVERVIEW – 3
B. POLICY OVERVIEW – 4
III. FACTORS CONSIDERED IN THE REVIEW OF RISK COMMUNICATION – 6
A. GENERAL CONSIDERATIONS – 7
1. Consistent Use of Language – 7
2. Use of Signals – 7
3. Framing Risk Information – 8
4. Hierarchy of Risk Information – 9
B. CONSIDERATIONS OF CONTENT – 10
1. Quantity – 10
2. Materiality and Comprehensiveness – 11
C. CONSIDERATIONS OF FORMAT – 14
1. Print Promotion – 15
2. Non-Print Promotion – 18
IV. CONCLUSION – 21
ATTACHMENT: STATUTORY AND REGULATORY REQUIREMENTS FOR LABELING AND ADVERTISING – 22

This draft guidance describes factors FDA considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act) and relevant regulations. The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors. This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and medical device promotional pieces to determine whether they adequately present risk information. The recommendations contained in this draft guidance apply to promotional materials directed to both consumers and healthcare professionals.