Fair Balance (FB) - PAAB Training Portal

Report
Creating, Selecting and Positioning
of Fair Balance
in HCP drug advertising
Dannie Newman
PAAB Reviewer
[email protected]
Fair Balance
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Fair Balance in the PAAB code
Creating the three levels of fair balance
Selecting the level of fair balance
Positioning fair balance
Fair Balance
• In alignment with section 9.1 of the Food and Drugs
Act, the PAAB Code sections 2.1, 2.4, 3.5 and 7.3
require that risk information be:
– Presented within the APS among the claims (s2.1.2)
– APS must reflect an attitude of caution (s2.4)
– Emphasis only on positive features of a drug while ignoring
negative findings is not acceptable (s3.5)
– Comprised of content type and quantity which adequately
balances the claims
– Accurate, Clear, Prominent
PAAB code
• Rx&D requested that the PI (Product Information) be
replaced with a link to the Product Monograph
• A committee of industry experts convened on how to
meet the above requirements in the context of
changes to PAAB code s7.3
• New PAAB code took effect on July 1, 2013
• Guidance documents created to assist in implementing
the code changes
Guidance Documents
Creating the three levels of
Fair Balance
Creating Fair Balance
• There are 3 levels of FB:
• See the guidance document “Guidance on Generating the
Three Base Fair balance Levels” on the PAAB website
Middle
Lowest
Decreased
comprehensiveness
Highest
Note: when highest
level FB is required,
PAAB allows option
to use middle FB
within an APS to
direct HCP
elsewhere within
the same media for
highest level FB.
Constructing the Highest Level
of base Fair Balance
Copy Framework:
Constructing the Highest Level
of base Fair Balance
Indications and Clinical Use:
• Must appear verbatim at least once in the APS (s2.10.2),
among or prior to first set of marketing benefit claims
(s2.10.1)
• Don’t need to repeat the indication (change section heading)
Contraindications:
• Include all contraindications except those which are standard
across all products (i.e. allergy to product or
ingredient/packaging
• Separate bullet points
Constructing the Highest Level
of base Fair Balance
Most Serious Warnings & Precautions:
• Summary of emphasized W&P from PM (e.g. bolded, boxed,
all-caps, underlined, or described as "serious" or equivalent)
are described.
• Bolded topic followed by description of the warning
Secondary Malignancies: The following secondary malignancies have
occurred, cutaneous squamous cell carcinoma, new primary
melanomas and non-cutaneous malignancy.
• Each risk description is separated by a white space
Constructing the Highest Level
of base Fair Balance
Other relevant warnings & precautions:
• Only need to include the topic, not a description (point is
to identify the W&P, directing the HCP to the TMA for
more information)
• Separate bullet point for each individual warning
• Can be grouped together if done so in TMA or if
considered to be adequately descriptive
• Be sure to identify if warning is in patients with a
preexisting condition, or if it is a side effect of the drug
Constructing the Highest Level
of base Fair Balance
For more information:
• Direct reader to complete TMA (link) for information not included in the fair
balance
• Must include link to the current TMA
• Documents are available upon request through a stated phone number
Example:
For More Information:
Please consult the product monograph at
www.websitepage.ca for important information
relating to adverse reactions, drug interactions,
and dosing information which have not been
discussed in this piece.
The product monograph is also available by calling
us at 1-800-XXX-XXXX
What can the link lead to?
Page housing TMA on the
product website
Product Information page on
the Health Canada Drug
Product Database
Directly to a PDF of the TMA
on the corporate page
www.toviaz.ca/PM1583
http://webprod5.hc-sc.gc.ca/dpdbdpp/info.do?code=86588&lang=eng
http://www.pfizer.ca/en/our_prod
ucts/products/monograph/317
Constructing the Highest Level
of base Fair Balance
Tips for Highest level fair balance
• There is no need to include content relating to indications which are
not promoted in the APS
• Content may be summarized provided the complete essence is
captured.
• No need to repeat info presented elsewhere in the APS (section
heading should reflect not complete)
– Manufacturers may still elect to spread fair balance throughout the APS.
• Risk elements which are bolded/boxed in the product monograph are
not required to be bolded/boxed in the fair balance presentation:
• Some content can be omitted at the manufacturer’s discretion:
– See page 11 appendix in guidance document for content that can
be removed from FB
Appendix from the Supplement: Guidance on
Generating the Three Fair Balance Levels
The following can be removed from the Fair Balance copy (at the
discretion of the Advertiser):
• Content which applies to all categories of drugs irrespective of
therapeutic area
– e.g. contraindications in patients with known allergies to the product or its
ingredients
– e.g. only use in those who are pregnant/nursing where benefits exceed
risk
• Instructions which are covered by standards of practice for all drugs
– e.g. instruct patients to keep out of reach of children
– e.g. only physicians who are knowledgeable with the product or class
should prescribe
• Copy which has been presented elsewhere in the advertisement/APS
• Copy which is promotional
Appendix from the Supplement: Guidance on
Generating the Three Fair Balance Levels
The following can be removed from the Fair Balance copy (at the
discretion of the Advertiser):
• Copy describing risks which have not been demonstrated to be
associated with the product
– e.g. Product was shown not be associated with weight gain
• Copy about alternative therapeutic options in case of adverse
effects on the advertisers product
– E.g. Dietary restrictions on Brand X may not extend to other products
in the class, another product within the class maybe tried with caution
• Explanations why the product is contraindicated in certain
populations
• Medical definitions and thresholds (except if within the indication
statement)
Indication
Revised
Constructing the Middle Level
of Fair Balance
Copy Framework
Indication statement unless stated elsewhere in the APS, e.g.
Headline
Consult the Product Monograph at www.Xgeva.ca/PM for important
information on:
• Contraindications in…
• Most serious warnings and precautions…
• Other relevant warnings and precautions…
• Conditions of clinical use, adverse reactions, drug interactions and
dosing instructions
The product monograph is also available by calling us at 1-800-xxx-xxxx.
Middle Level of Fair Balance
FAMILAZE acts by inhibiting prostaglandin synthesis
Inhibits prostaglandin G/H
synthase isoenzymes
Also know as COX-1 and COX-2
(p<0.01)*

Familaze (rulomine hydrochloride) is indicated for
the management of chronic pain associated with
osteoarthritis (OA) of the knee
Consult the product monograph at www.familaze.ca for important information about:
Contraindications in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma,
hypersensitivity to tolterodine L-tartrate, soya, peanuts, lactose.
 Relevant warnings and precautions regarding increased heart rate, interaction with potent CYP3A4 inhibitors,
patients at risk of gastric retention, patients at risk of urinary retention, patients with impaired hepatic function,
angioedema, patients with myasthenia gravis, patients with controlled narrow-angle glaucoma, patients with
impaired renal function, and use of contraception in women of childbearing potential.
 Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions.

The Product Monograph is also available by calling us at 1-800-000-0000
Constructing the Lowest Level
of Fair Balance
Indication statement unless stated elsewhere in
the APS
Consult the Product Monograph at
www.Xgeva.ca/PM for important information on
contraindications, warnings, precautions,
adverse reactions, interactions, dosing and
conditions of clinical use. The Product
Monograph is also available by calling us at 1800-xxx-xxxx.
Selecting the level of Fair Balance
Selecting Fair Balance Level:
• Dependent on the type of claims in the APS
No pharmacologic
claims
Highest
Middle
Lowest
Decreased
comprehensiveness
Therapeutic
claims
Pharmacologic
claims
Selecting Fair Balance Level:
Highest level required if APS contains any of the
following:
 Therapeutic claim (e.g. efficacy, safety, tolerability)
 Compliance/adherence claim
 Place in therapy claim (e.g. 1st line treatment)
 Pharmacoeconomic claim
 Beneficial aspects of risk/burden profile from TMA
If not (aside from indication), go to next slide…
Selecting Fair Balance Level:
Middle level required if APS contains any of the
following:
 Pharmacologic claims other than any of those listed on
prior slide (e.g. pharmacokinetics/pharmacodynamic),
 Presentations describing predefined measured
endpoints from clinical trials without disclosing results
(e.g. ongoing studies)
If not (aside from indication), go to next slide…
Selecting Fair Balance Level:
Lowest level required if APS contains any of the
following:
 non-pharmacologic claims
 healthcare product messages other than marketing
benefit claims (e.g. cautionary content)
 messages which do not relate to the healthcare
product (e.g. disease information)
Selecting Fair Balance Level:
• Examples of non-pharmacological claims
–
–
–
–
–
market positioning/experience claims
Tablet characteristics/sensory characteristics (i.e. taste/smell)
cost comparisons
cosmetic/packaging/device characteristics
study characteristics without mention of endpoints (e.g. “largest
published RCT in diabetes”)
– plea to choose/prescribe the product or plea to write “do not substitute” if
physician wants to ensure patient receives brand X
– claims relating to instructions for use, dosage and or administration
information (whether comparative or non-comparative) provided the claim
does not allude, in any way, to topics discussed in slide 1
If not, consider whether exempt per s6.6.
If unsure submit for an opinion.
How the drug interacts with
the body in a therapeutic way
How the drug interacts with
the body in a non-clinical way
Claims that don’t relate to an
interaction between the
product and the body
None of the above?
Is this piece exempt (s6.6)?
Testing your FB knowledge
• Which level of FB would you choose?
L
H
L
1) The first and only once-daily antihypertensive therapy
2) A new dose delivery system. Demonstrated safety
profile
3) For patients with irritable bowel syndrome
NOTE: If after a trial of 2 weeks, patient continues to experience
similar side effects and no greater efficacy than previous therapy,
continued use should be reassessed.
M 4) New Rizaren Tablet for ulcerative colitis
Rizaren tablets have microgranules that provide predictable, uniform
drug release and delivery.
Positioning of Fair Balance
Positioning of Fair Balance
• Risk information should be where the claims
are (meaning in the same parts of the APS).
• Risk information should be accorded a degree
of prominence which is similar to the claim
content.
Positioning of Fair Balance
• Indication statement
– Must appear verbatim in the APS (s2.10.2)
– Must appear prior to or among the first set of
marketing benefit claims (s2.10.1)
• A statement that is designed to promote the sale of a
health product
• It often promotes a specific product attribute
Positioning of Fair Balance
General Requirements:
– Fair balance should be visually comparable to body copy
– Factors to consider in assessing prominence:
•
•
•
•
•
•
type size (at least 75% of body copy)
spacing
duration, pace
contrast/shade
Readability
location
Positioning of Fair Balance
General Requirements
– Fair balance should generally not be presented below
product logos (+/- tagline), references, legal mice type
and/or footnotes
– These elements tend to mark the end of the advertising
message portion on a surface
Corporate signoff
Footnotes
Product logo
Positioning of Fair Balance
Middle to Highest level fair balance
• When highest level of fair balance is required you
have the option to use middle fair balance direct
the reader to the highest level fair balance
Linking Middle to Highest Fair Balance:
• The highest fair balance must be within the same tool (or directly attached
to it) AND in the same media.
– pull out the dosing ruler to reveal the highest fair balance.
– electronic banner ad directs reader to click a link which takes him/her directly to the
highest fair balance.
• The middle fair balance must lead directly to highest level fair balance.
• Access to the highest fair balance should require little to no effort in dayto-day use of the piece.
• Surface must be easy to read
Linking Middle to Highest Fair Balance:
Middle fair balance must be:
• Within the main advertising message
• Wording must be adjusted to reflect language
directing to the highest level fair balance
High Level of Fair Balance
40
Middle Level of Fair Balance
41
… with High Level Fair Balance Option
Positioning of Fair Balance
• Linear tools vs. non-linear tools
• Websites
– Safety information should appear on
homepage/surface
– Safety information tab in menu items which is
accessible from all screens (links to highest level of
fair balance)
Positioning of Fair Balance
• Consider fair balance and indication
positioning in:
– a print detail aid
– an email
Example: Sample Holder
exterior side
surface
Example:
Dosing Slide-out Ruler
Summary of Fair Balance
• How to create the three levels of fair balance
• How to select the level of fair balance
required based on the claims in the APS
• Where to position the fair balance copy in the
APS
Any questions??

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