Download FDA recommends a new approach for consumer

NOAH BEYTIN, DIRECTOR, REGULATORY REVIEW
FEBRUARY 9, 2015
Regulatory Alert: FDA recommends a new
approach for consumer brief summaries
On February 6, 2015, the Food and Drug Administration (FDA) released a new draft
guidance entitled Brief Summary and Adequate Directions for Use: Disclosing Risk
Information in Consumer-Directed Print Advertisements and Promotional Labeling. FDA
strongly recommends against the use of the traditional approach to disclose risk
information and fulfill the brief summary requirement in consumer-directed
advertisements. It outlines an alternative approach that the FDA is calling a “consumer
brief summary,” which encourages a less-is-more-approach that reduces requirements
for disclosing risk information. It’s worth noting that this guidance is only for consumer
advertising. It does not apply to advertisements directed at health care professionals.
KEY TAKEAWAYS
1. New recommendations for consumer brief summary only apply to
consumer-directed materials
2. FDA strongly recommends against the traditional approach to
fulfill the brief summary requirement in consumer-directed
advertisements with the use of the full FDA-approved package
insert (PI)
3. FDA also strongly recommends against providing the PI
4. New recommendations for using a consumer brief summary do
not change requirements for the main body of promotional
materials
5. The consumer brief summary should be presented visually in a
manner similar to the promotional content
6. Simplify language to be more consumer-friendly
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RECOMMENDATIONS
In light of this guidance, Digitas Health LifeBrands recommends companies take the following actions:
1. Review all consumer promotional materials in market and in development and assess where to
use a consumer brief summary
2. Choose the format of the consumer brief summary
3. Decide on a timeframe for updating current brief summary

There is no timeframe for adherence to these new recommendations

Comments on the proposed guidance will be accepted for 90 days, after which the FDA
will review and decide how to proceed
4. Determine if multiple consumer brief summaries are necessary for co-promotions or products
with multiple indications
5. MLR, brand managers, and agencies should work together to determine the appropriate steps to
implement the new guidance
GUIDANCE DETAILS
As stated above, FDA strongly recommends an alternative approach to disclose risk information and
adequate directions for use using a consumer brief summary instead of the traditional format using a full
package insert PI. This guidance specifically affects requirements to contain all information in brief
summary relating to side effects, contraindications, and effectiveness. It only applies to consumer
promotional labeling and does not affect the main body of promotional materials. The FDA does not
intend to object for failure to include:

Each side effect from the PI in the brief summary in consumer-directed advertising

The entire PI in consumer-directed advertising
Additionally, the brief summary should focus on the most important risk information rather than an
exhaustive list of the risks, and should be presented in a way most likely to be understood by the
consumer since:

FDA believes that exhaustive lists that include all minor risks detract from the ability for
consumers to comprehend and retain information about the more important risks

Research has shown that people process only a limited amount of information at one time

Research has shown that alternative formations for the brief summary outperform the traditional,
non-consumer-friendly brief summary on measures of consumer risk comprehension
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FDA RECOMMENDS
FDA recommends two approaches:
1. Format similar to over the counter (OTC) Drug Facts box
2. Questions and Answer format (Q&A)
FDA recommends that the brief summary should:

Avoid technical language, scientific terms, medical jargon

Use headlines and subheading

Consider how font size and type style affect the readability of information

Select font for readability

Be presented visually in a manner designed for ease of use by consumers

Carry over elements of the main body of the ad (such as logos and branded colors)

Use double spacing between paragraphs and indentations as opposed to plain block paragraphs,
which helps to maximize background space (white space) and improves readability

Arrange information in text boxes (i.e., paragraphs of information on a similar topic surrounded
by borders) with headings and other attention-drawing symbols (e.g., bullets, capitalization of
select words or phrases)
The most serious and the most common risk associated with the product should be included, while less
pertinent information should be omitted. Furthermore, FDA recommends using available standards to
determine which risks should be included. For example:


FDA-approved patient labeling and Medication Guides may be an appropriate starting point
o
Some information – such as information found in the Directions for Use section – is not
necessary to include in the consumer brief summary
o
Information not contained in patient labeling such as certain relevant drug risks, might
need to be added to the consumer brief summary
The Highlights of Prescribing Information (Highlights), as found in promotional materials for new
and recently approved products, may also be an appropriate starting point
o
Place information in order similar to Highlights section
1. Boxed warning
2. Contraindications
3. Warnings and precautions
4. Etc.
o
The Highlights section is intended for use with a Full PI and in the consumer brief
summary one will not be provided so more detail may be required
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All approaches to creating a patient brief summary must include information addressing the following:
1. Boxed Warnings
2. All Contraindications
3. Certain information regarding Warnings and Precautions:
o
Most clinically significant information from the Warnings and Precautions section of the PI
o
Information that would affect a decision to prescribe or take a drug
o
Monitoring or laboratory tests that may be needed
o
Special precautions not set forth in other parts of the PI
o
Measures that can be taken to prevent or mitigate harm
FDA recommends that most frequently occurring adverse reactions be included as follows:

If more than one indication, the most common adverse reactions for each indication being
promoted should be included

Adverse reactions should be listed in the same order as in the PI

Include other important adverse reactions that are serious or that lead to discontinuation of the
drug or dosage adjustment, unless they are repeated elsewhere in the PI (e.g., risks in the
warning and precautions)

Material information may be included about the severity of risk
o
Debilitating
o
Life-threatening
o
Irreversible
o
Whether stopping the medication will alleviate or mitigate the risks
o
If early warning signs of risks are known
o
Need for monitoring or testing during treatment
o
Other risk information depending on drug and its risk profile

Include the indication for use

Include clinically significant drug interactions

Include information on topics consumers should discuss with their HCP

Include relevant information on other drugs they are taking or pre-existing conditions

Include other info specific to a drug and the indication being promoted (e.g., a drug that is not
indicated for use for more than 4 weeks [Even if a different indication allows for a longer use]) or
information relating to specific populations (e.g., children, the elderly, pregnant or nursing
women, people with liver or renal impairment [e.g., not recommended for use in children based
on adverse events; not for use in nursing women due to potential for harm to the infant])
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Information in the PI or FDA-approved patient materials that can be excluded may include:

Dosage and administration

How the drug is supplied

Clinical pharmacology

Specific directions regarding use of the drug, for example:

o
How to perform an injection or how to use a patch
o
How long the drug takes to work
Excluding certain information from the consumer brief summary does not mean that the same
information can be omitted from other parts of the promotional piece (e.g., information that a drug
is administered via an injection versus orally might be material information that is required in the
main body of the promotional piece but omitted in the consumer brief summary)
Brief summary should include a statement to consumers that the information presented is not
comprehensive and suggest that consumers speak to their health care provider or pharmacist. It should
contain a toll free telephone number or website address where consumers can obtain the FDA-approved
product labeling. Two examples:
1. The risk information provided here is not comprehensive. To learn more, talk about [drug name]
with your health care provider or pharmacist. The FDA-approved product labeling can be found
at www.drugnamePI.com or 1-800-555-DRUG
2. This information is not comprehensive
o
How to get this information
o
Talk to your health care provider or pharmacist
o
Visit www.drugnamePI.com to obtain the FDA-approved product labeling
o
Call 1-800-555-DRUG
Brief summary may include a title such as, Important Facts or Summary of Information about… along with
the drugs name
Two recommended formats include:
1. Layout similar to OTC Drug Facts box
o
Uses
o
Do not use if you
o
Warnings
o
Ask a health care provider before use if
o
When using this product you may have
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2. Question & Answer format in columns or similar layout, headings in questions format
o
What is [drug] used for?
o
When should I not take [drug]?
o
What warnings should I know about [drug]?
o
What should I tell my health care provider?
o
What are the side effects of [drug]?
o
What other medications might interact with [drug]?
KEY TAKEAWAYS
1. New recommendations for consumer brief summary only apply to consumer-directed materials
2. FDA strongly recommends against the traditional approach to fulfill the brief summary requirement in
consumer-directed advertisements with the use of the full FDA-approved package insert (PI)
3. FDA also strongly recommends against providing the PI
4. New recommendations for using a consumer brief summary do not change requirements for the
main body of promotional materials
5. The consumer brief summary should be presented visually in a manner similar to the promotional
content
6. Simplify language to be more consumer-friendly
The content of the full guidance is available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM06998
4.pdf
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