Download Fair Balance - PAAB Training

Creating, Selecting and Positioning
of Fair Balance
in HCP drug advertising
Malika Ladha
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 requirements for nonprescription healthcare products (e.g. OTC,
NHP)
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
Search page on the Health
Canada Drug Product
Database
Directly to a PDF of the TMA
on the corporate page
www.toviaz.ca/PM1583
http://www.pfizer.ca/en/our_prod
ucts/products/monograph/317
http://webprod5.hc-sc.gc.ca/dpdbdpp/index-eng.jsp
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)
Example – JENSULIN FB
• Highest level of fair balance on the last page
of a multiple page leave behind
• Indication placed on the first page of the APS
with first set of marketing benefit claims
Fair balance headings must be bolded
Indications and clinical use:
•
JENSULIN [sublingual basal insulin praspart] is indicated for the treatment of Type 1 or Type 2
diabetes in patients over 17 years of age who require basal insulin for the control of hyperglycemia
•
Caution in elderly patients (≥65 years of age) as they are more likely to have impaired renal function
Can be revised to “Clinical use” and indication
statement can be removed from the section
Contraindications:
•
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container
Serious warnings and precautions:
Hypoglycemia: Most common adverse effect of insulin,
including
Revise
to JENSULIN
“Most serious
•
Glucose monitoring is recommended
warnings and precautions”
•
Uncorrected hypo- or hyperglycemia can cause loss of consciousness, coma or death
Administration:
•
Changes to insulin should be made cautiously and only under medical supervision
Insert line
white space
•
Not intended to be eaten or administrated
as aof
suppository
•
Must not be mixed with any other insulin
“Contraindications” section
can be removed
Other relevant warnings and precautions:
•
Hypokalemia
•
Sodium retention and edema
•
Patients with human insulin antibodies
•
Combination of TZD with insulin is not indicated for the treatment of Type 2 Diabetes Mellitus
•
Hyperglycemia and diabetic ketoacidosis
•
Patients with oral inflammation or oral wounds
•
Local and systemic allergic reactions, antibody production
•
Patients with hepatic or renal impairment
Should be a direct link to the TMA
For more information:
Please consult the JENSULIN Product Monograph at www.jensulin.ca for important information relating to adverse reactions,
drug interactions and dosing information, which have not been discussed in this piece.
Statement that the Product Monograph is available
through a stated phone number
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.
JENSULIN Middle Level
of Fair Balance
JENSULIN [sublingual basal insulin praspart] is indicated for the treatment of Type 1 or
Type 2 diabetes in patients over 17 years of age who require basal insulin for the
control of hyperglycemia.
Consult the product monograph at www.jensulin.ca/JENSULINTMA for important
information about:
• Most serious warnings and precautions regarding hypoglycemia and administration
• Other relevant warnings and precautions regarding hypokalemia, sodium retention
and edema, patients with human insulin antibodies, combination of TZD with
insulin in the treatment of Type 2 Diabetes Mellitus, hyperglycemia and diabetic
ketoacidosis, patients with oral inflammation or oral wounds, local and systemic
allergic reactions, antibody production, patients with hepatic or renal impairment
• Conditions of clinical use, adverse reactions, drug interactions and dosing
instructions
The Product Monograph is also available through our medical department. Call us at
at 1-800-123-4567.
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.
JENSULIN Lowest Level
of Fair Balance
JENSULIN [sublingual basal insulin praspart] is indicated for the treatment of Type 1 or
Type 2 diabetes in patients over 17 years of age who require basal insulin for the
control of hyperglycemia.
Consult the product monograph at www.jensulin.ca/JENSULINTMA for
contraindications, warnings, precautions, adverse reactions, interactions, dosing, and
conditions of clinical use. The product monograph is also available through our
medical department. Call us at 1-800-123-4567.
Indications and clinical use:
JENSULIN [sublingual basal insulin praspart] is indicated for the Other relevant warnings and precautions:
treatment of Type 1 or Type 2 diabetes in patients over 17 years Hypokalemia
of age who require basal insulin for the control of hyperglycemia Sodium retention and edema
Caution in elderly patients (≥65 years of age) as they are more Patients with human insulin antibodies
likely to have impaired renal function
Combination of TZD with insulin is not indicated for the
treatment of Type 2 Diabetes Mellitus
Most serious warnings and precautions:
Hyperglycemia and diabetic ketoacidosis
Hypoglycemia: Most common adverse effect of insulin, including Patients with oral inflammation or oral wounds
JENSULIN
Local and systemic allergic reactions, antibody production
Glucose monitoring is recommended
Patients with hepatic or renal impairment
Uncorrected hypo- or hyperglycemia can cause loss of
consciousness, coma or death
For more information:
Please consult the JENSULIN Product Monograph at
Administration:
www.jensulin.ca/JENSULINTMA for important information
Changes to insulin should be made cautiously and only under
relating to adverse reactions, drug interactions and dosing
medical supervision
information, which have not been discussed in this piece. The
Not intended to be eaten or administrated as a suppository
Product Monograph is also available by calling us at 1-800-123Must not be mixed with any other insulin
4567.
Consult the product monograph at www.jensulin.ca/JENSULINTMA for important information about:
• Most serious warnings and precautions regarding hypoglycemia and administration
• Other relevant warnings and precautions regarding hypokalemia, sodium retention and edema, patients with human insulin
antibodies, combination of TZD with insulin in the treatment of Type 2 Diabetes Mellitus, hyperglycemia and diabetic
ketoacidosis, patients with oral inflammation or oral wounds, local and systemic allergic reactions, antibody production,
patients with hepatic or renal impairment
• Conditions of clinical use, adverse reactions, drug interactions and dosing instructions
The Product Monograph is also available through our medical department. Call us at at 1-800-123-4567.
Consult the product monograph at www.jensulin.ca/JENSULINTMA for contraindications, warnings, precautions, adverse
reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical
department. Call us at 1-800-123-4567.
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
• 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
• 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
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
41
Middle Level of Fair Balance
42
… 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)
Example:
Dosing Slide-out Ruler
Fair Balance for non-prescription
healthcare products (s2.4.3)
Fair balance requirement can*
be met by:
Fair Balance statement required:
For products with a
Product Monograph (PM)
“Please consult the Product Monograph available at
[insert link to the PM] for information to assist in benefitrisk assessment. Always direct the patient to read the
label” (s2.4.3i)
For products without a PM
“See Warnings, Cautions, and Directions of Use at
[insert link to the TMA] for information to assist in
benefit-risk assessment. Always direct the patient to read
the label” (s2.4.3ii)
- Fair balance statement must be accompanied by statement with phone # to access TMA
- Electronic APS: phone # is not needed if electronic link provided to the TMA
- Indication must appear within the APS (s2.10)
*Not required if all relevant TMA info on ad
“All Relevant” means (s7.2.1)
• Medicinal ingredients (s11)
• The approved use
• All of the following relating to the promoted use:
– Cautions & warnings
– Contraindications
– Interactions
– Known adverse events
– Dosing info
s2.4.3i) of PAAB Code
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??