1. FDA DRAFT GUIDANCE FOR INDUSTRY
REVISED
Stuart E Coleman
Promotional Review and Regulatory
March 30th, 2015 1

2. Brief Summary and Adequate Directions for Use:
Disclosing Risk Information in Consumer-Directed
Print Advertisements and Promotional Labeling for
Human Prescription Drugs (Feb 2015)
Overview and Summary
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3.  Historical Perspective – original Draft Guidance
 Summary of the February 2015 Revised Draft Guidance
 Guidance objectives
 Why has it changed?
 What has changed?
 Case Summary Example (Lunesta)
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4. FDA Guidance Summary (January 2004)
• Historical Perspective
– In January 2004, the FDA came out with a Draft Guidance on Patient Labeling
– In the approved FDA Patient Label, the Guidance states:
• FDA-approved patient labeling does not address each specific risk included in the
FDA-approved professional labeling. Instead, FDA-approved patient labeling communicates
the most important information patients need to use the product appropriately, and it focuses on
product’s most serious risks and its less serious, but most frequently occurring, adverse
reaction.
– The Guidance further states that the Label can be reprinted as it was approved for the
Professional Label:
• Contraindications: all;
• Warnings: all;
• Precautions: the major precautions, including any that describe serious adverse drug
experiences (as defined in 21 CFR 312.32(a) & 314.80(a)) or steps to be taken to avoid such
experience
• Adverse Reactions: the 3-5 most common nonserious adverse reactions most likely to affect
• Patient's quality of life or compliance with drug therapy.
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5. Revised Draft Guidance 2015
The FDA now believes that the traditional approach
that has been used for Consumer promotional labels
and advertising are no longer as useful since the
consumer for the most part lacks the technical skill
and background to understand the vast amount of
the information in the PI
Note: The revised guidance is in draft form and comments are due to the FDA by 5/11/2015 which was 90 days from the
release of the FDA’s Proposed changes.
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6. Revised Draft Guidance 2015
• Objective
– To provide recommendations on the disclosure of risk information in prescription
drug product advertisements and promotional labeling in print media directed toward
consumers
– The brief summary requirement and the requirement that adequate directions for use
be included with promotional labeling. The recommendations describe an alternative
disclosure approach that FDA refers to as a consumer brief summary.
– Note - this revised draft guidance does not focus on the presentation of risk
information in the main body of promotional labeling or advertisements and does not
apply to promotional materials directed toward health care professionals.
– This revised draft guidance revises the draft guidance entitled Brief Summary:
Disclosing Risk Information in Consumer-Directed Print Advertisements (issued
January 2004).
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7. Revised Draft Guidance 2015
• Why change?
– This revised draft guidance responds to stakeholder requests for specific
guidance on the disclosure of risk information to consumers and incorporates
recent social science research results (Aikin, O’Donoghue, et al. 2011).
– Consumer-directed print advertisements for prescription drugs frequently use
the “traditional approach or format”, which utilizes the full FDA-approved
package insert (PI)
– The FDA believes the “traditional” approaches are not optimal for consumer-
directed prescription drug print advertisements and promotional labeling.
Consumers lack the technical background to understand some of the
information as described in the PI
– Information may be of limited use to consumers (e.g., clinical pharmacology)
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8. Revised Draft Guidance 2015
What are the Changes?
– This revised draft guidance recommends alternative approaches firms may
use to develop content that can be used to fulfill both the brief summary
requirement for consumer-directed prescription drug print advertisements
and the requirements in 201.100(d) in consumer-directed prescription drug
print promotional labeling pieces
– Draft guidance provides suggested research-tested formats for this
information.
– Firms may use alternative approaches if these approaches satisfy the
requirements of the statute and regulations.
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9. FDA’s Recommendations
• CONSUMER LANGUAGE & READABILITY
– The FDA “strongly encourages” the language below as guidance for
consumer labeling:
Professional Consumer
Contraindications Do not use if you have…
Who should not use…
Indication What is [drug name]
Cephalalgia Migraine
Syncope Fainting
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10. FDA’s Recommendations
• CONSUMER LANGUAGE & READABILITY
– Brief summary should be presented visually in a manner designed
for ease of use by consumers.
– Use elements in the main body of the ad – like logos and approved
branded colors.
– Font size and style should be selected and designed for readability
– Double space and indentations for white space
– Arranging information in text boxes (using borders and headings)
– Using other types of attention drawing symbols and such as bullets,
capitalizations and consumer friendly words and phrases
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11. FDA’s Recommendations
• CONTENT
– FDA suggests that the brief summary should provide clinically significant
information on the most serious and the most common risks associated with
the product and omit less pertinent information
– As a starting point, the FDA suggests that an FDA-approved patient label
and Medication Guides, if available for the drug at issue, may be an
appropriate starting point to determine which risks should be included in
the consumer brief summary
– (The client will know which AE’s and which common risks that they will
want to include)
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12. FDA’s Recommendations
• CONTENT
– Creating the Consumer Brief Summary and should include:
– Medication Guides if available
– Information from the Highlights Section
– Should be placed in order of severity such as, Boxed Warning, Contraindication,
Warnings and Precautions
– Certain information regarding Warnings and Precautions
• the most clinically significant information from the Warnings and Precautions
section(s) of the PI
• information that would affect a decision to prescribe or take a drug;
• monitoring or laboratory tests that may be needed;
• special precautions not set forth in other parts of the PI
• measures that can be taken to prevent or mitigate harm.
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13. FDA’s Recommendations
• CONTENT
– Creating the Consumer Brief Summary and should include: (cont.)
• Adverse Events (AE’s)
• Most occurring
• If a product has more than one indication, the most common
Adverse Reactions for each indication being promoted should be
included, if included in the PI
• Other serious AE’s that lead to discontinuation or dosage
adjustment
• Any debilitating, life threatening, or irreversible effects or risks
• May also include any monitoring or testing during treatment
• Special populations (children, minorities, women, etc.)
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14. FDA’s Recommendations
• CONTENT
– Creating the Brief Summary Does not need to include:
• Dosage
• How it is administered
• How it is supplied
• Clinical Pharmacology
• Specific Directions
• How long it takes to work
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15. FDA’s Recommendations
• CONTENT
– Additional comprehensive information recommended by the FDA
• Since not all info will be included on the label, the FDA has recommended the
following formats and language
• The risk information provided here is not comprehensive. To learn more, about
[drug name] talk with your health care provider or pharmacist.
• The FDA- approved product labeling can be found at www.drugnamePI.com or
1-800-555-DRUG
• This information is not comprehensive.
– How to get more information:
– Talk to your health care provider or pharmacist 325
– Visit www.drugnamePI.com to obtain the FDA-approved product labeling
– Call 1-800-555-DRUG
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16. FDA’s Recommendations
• FORMAT
– The FDA has suggested two formats:
– Drug Facts Box which the information could appear as it does
on an OTC Drug Facts Box with standardized headings:
• Who Uses
• Do not use if you ….
• Warnings
• Ask a health care provider before use
• When using this product you may have
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17. FDA’s Recommendations
• FORMAT
– The FDA has suggested two formats:
– A Question and Answer (Q&A) format simulates a dialogue using
personal pronouns, thus increasing consumer interest in, and
comprehension of, the information.
What is drug used for? ANS
When should I not take drug? ANS
What should I tell my HCP? ANS
What are the side effects? ANS
Are there other meds that might
interact?
ANS
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18. LUNESTA Label*
BOX Q & A
• Provides the What, Who, the clinically
significant things to monitor and for and
grouped it as “abnormal behavior”
• They move a step further with Biometrics
and give the clinical data from their
pivotal trial that shows the risk/benefit
profile.
• The last paragraph at the bottom gives
the information of how long the drug has
been used and also gives the information
that “ as with all new drugs, not enough
patients have taken to show the full
safety profile”
*Please note – The LUNESTA Label shown is a “mock” up taken from
PHARMA NETWORK ONLINE - 2015 18

19. FDA’s Recommendations
• The FDA will, at times, make “suggestions” and the
occasional “recommendation The following uses rather
strong language and therefore should really be adhered to
from a marketing/advertising agency standpoint.
• FDA strongly recommends against
the use of the traditional approach to fulfill the brief summary
requirement, an approach in which risk related sections of
the PI are presented verbatim, often in small font, technical
language that is difficult for consumers to comprehend
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20. Recommendation for Hill Holliday’s
Point of View
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Hill Holiday will recommend one of the two proposed formats in
this Guidance based upon:
• Type of product
• Type of information to convey
• Volume of information to convey
• Type of media being used to display the summary
“Hill Holiday will provide clients with advice and
comments according to its best understanding of the FDA
Guidance and applicable regulations.
As with all marketing and labeling materials, final approval
of said materials is the sole responsibility of the client.