Introduction to the Regulation of Advertising

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Introduction to the Regulation of Advertising

• PRA700

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Why Regulate?

• All drugs pose an element of risk and benefit
• Minimize the risks associated with the selection
  and use of drug products

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What is Advertising?

• Defined in the Food Drugs Act as
• any representation by any means whatever for the
  purpose of promoting directly or indirectly the
  sale or disposal of any food, drug, cosmetic or
  device.

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General Prohibitions on Content of Drug
Advertising

• Section 9(1) of the Food and Drugs Act
• No person shall label, package, treat, process,
  sell or advertise an drugin a manner that is
  false, misleading or deceptive or is likely to
  create an erroneous impression regarding its
  composition, merit or safety.

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Prior to Market Authorization...

• Promotion of a drug prior to market authorization
  is not permitted according to Act - Section 9(1)
  and Regulations - Section C.08.002

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Following Market Authorization

• Promotion of a Schedule F drug to the general
  public is limited to name, price and quantity
  (Regulations - Section C.01.044)
• No drug can be advertised to the general public
  for the treatment, preventative or cure for any
  Schedule A disease (Act - Section 3)

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Distinction Between Advertising and Other
Activities

• What is the context in which the message is
  disseminated?
• Who are the primary and secondary audiences?
• Who delivers the message?
• Who sponsors the message and how?

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Distinction Between Advertising and Other
Activities

• What influence does a drug manufacturer have on
  the message content?
• What is the content of the message?
• With what frequency is the message delivered?

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Role of Health Canada

• Drug advertisements are reviewed and pre-cleared
  by independent agencies endorsed by Health
  Canada.
• These agencies are Advertising Standards Canada
  (ASC) and the Pharmaceutical Advertising Advisory
  Board (PAAB).
• ASC reviews advertising material for
  non-prescription drugs directed to consumers,
  while PAAB reviews advertisements for all drugs
  directed to health professionals.

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Role of Health Canada

• In addition, ASC and PAAB also provide advisory
  opinions on messages directed to consumers for
  prescription drugs to ensure that they meet the
  regulatory requirements.
• Additional information regarding the roles of
  the ASC and PAAB in relation to the Department
  are located on the HPFB Website.

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Role of Health Canada

• Although it is not mandatory, various
  manufacturer associations such as the
  Nonprescription Drug Manufacturers' Association
  of Canada (NDMAC) and Canada's Research-Based
  Pharmaceutical Companies (Rx D) support
  pre-clearance by ASC and PAAB.

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Role of Health Canada

• Health Canada strongly encourages all sponsors to
  comply with the voluntary pre-clearance review
  prior to exposure to health care professionals
  and consumers.

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TPP Bureau

• Bureau of Licensed Product Assessment (BLPA),
  Advertising and Communications Unit

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Role of BLPA

• National regulatory authority
• Sets the parameters under which products are
  marketed
• TPP sets standards by developing regulations,
  guidelines and policies

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Role of BLPA

• TPP intervenes when advertising contravenes the
  Regulations and poses a significant health hazard
• or when pre-clearance agencies are agency unable
  to ensure willful compliance
• Responds to incidences of illegal pre-market
  promotion

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Role of BLPA

• TPP does not approve advertising
• Approval is granted by the two pre-clearance
  agencies in Canada

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Policies

• Canadian Advertising Foundation and Drugs
  Programme Roles and Consultation Related to
  Advertising Review and Complaint Adjudication,
  2001-01-22
• The Distinction Between Advertising and Other
  Activities, 2000-11-03
• PAAB Code
• Canadian Code of Advertising Standards

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Pre-Clearance Agencies

• Pharmaceutical Advertising Advisory Board (PAAB)
• Health Professionals
• All drugs
• Advertising Standards Canada (ASC)
• Consumers
• OTC drugs

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Pre-Clearance Agencies

• ASC and PAAB review and pre-clear advertising
  material to determine compliance with the
  regulatory provisions of the Food Drugs Act and
  Regulations and the various codes of advertising.
  
• The agencies also offer independent mechanisms to
  resolve complaints on advertising for approved
  drugs.

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ASC

• Responsible for pre-clearing consumer-directed
  broadcast and mass media print advertising for
  nonprescription drugs
• Review of advertising materials is product
  specific
• CAF Standards and Procedures are consistent with
  the principles outlined in the advertising
  provisions of Act, Regulations and
  Guidelines/Policies

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PAAB

• An independent review agency whole primary role
  is to ensure that advertising of prescription
  drugs is accurate, balanced and evidence-based

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PAAB

• Key activities
• Maintaining a Code of Advertising Acceptance
• Pre-clearing advertising prior to publication
• Education on the application of Code standard
• Encourage compliance with Code standards by ad
  monitoring, adjudicating complaints, reporting
  infractions and administering penalties

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PAAB Code

• Applies to all communications in which claims,
  quotations and references are made for single
  entity and compound prescription and non
  prescription drugs
• all Advertising/Promotion Systems (APS) must be
  accurate, complete and clear
• designed to promote credibility and trust

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QA
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PAAB

• PRA700

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PAAB

• Pharmaceutical Advertising Advisory Board
• incorporated in 1976
• Independent review agency
• ensures that drug advertising is accurate,
  balanced, and evidence-based
• self-financing organization

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Key Activities

• maintain a Code of Advertising Acceptance
• includes advertising of prescription and OTC
  products to health professionals, in all media
• preclearing advertising prior to publication
• activities to encourage compliance
• training, dealing with complaints, penalizing
• consulting on matters of policy

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1. Scope

• applies to all Advertising/Promotion Systems
  (APS)
• only drugs for which safety and efficacy has been
  proved and a DIN has been assigned can be
  advertised

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. . . . . . .Scope

• applies to all communications in which claims,
  quotations and references are made for a single
  entity (prescription and OTC) pharmaceutical
  product
• applies to medicine, dentistry, nursing, pharmacy
• everything must be reviewed by PAAB

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2. General Requirements

• APS must be accurate, complete, and clear
• designed to promote credibility and trust
• statements or illustrations must not mislead

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. . . . . . General Requirements

• the trade name, the generic name, and the Federal
  drug schedule should appear at least once
• must reflect an attitude of caution
• emphasis on rational drug therapy
• must not be prejudicial to any race, sex,
  occupation or patient group
• must not be appear offensive

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. . . . . . General Requirements

• cannot claim 100 safe or effective
• must not imitate the advertisements of other
  pharmaceutical companies
• promotional items must
• be related to the product
• be of practical use to the health care
  professional
• withstand professional and public scrutiny

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3. Claims, Quotations, and References

• must be consistent with the product monograph
• APS containing direct/indirect quotes from the
  scientific literature must include references

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. . .Claims, Quotations, and References

• references must be current and accessible
• cannot emphasize positive while ignoring negative
  facts
• cannot refer to other products with the same
  active substance

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4. Data Presentations

• All APS data, such as charts, graphs, and tables
• must be accurate, complete, and clear
• sources must be identified
• Statistics must accurately reflect their
  validity, reliability, and level of significance
  (95 CI)

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5. Comparisons

• consistent with Section 9(1) of the Act
• the compared drugs have an authorized use in
  common
• a second use can be claimed as an added benefit
  of the advertised drug
• comparison is drawn under same conditions

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. . . . .Comparisons

• product cited in comparative claim should be the
  formulation used in actual studies
• cross-reference to non-Canadian studies not
  permitted unless bioequivalent evidence is
  presented

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. . . . . . .Comparisons

• the claim is of clinical use to humans
• should identify the compared entities
• cannot claim better, faster acting
• cannot say compared to the leading brand
• cannot attack compared drug product/ingredients
  in and unreasonable manner

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. . . .Comparisons

• comparative claim is not more important than
  therapeutic use
• comparative claims require support from
  head-to-head well-designed, blinded, randomized
  trials
• results should be independently reviewed (e.g.
  published)
• should be statistically significant

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. . . . .Comparisons

• relevant data from product monographs cannot be
  left out
• scare tactics or superlatives cannot be used
• cannot claim or imply superiority or special
  status for a company, its personnel, services or
  product line

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6. APS Categories

• journal advertisements
• prescribing information must be included
• direct mail
• brochures, instruction sheets, surveys, etc.
• detail aids
• includes conference exhibits
• AV and electronic
• cassette tapes, computer software, etc.

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6. Exemptions to PAAB

• educational materials that have been
  independently prepared
• personal correspondence
• government agency correspondence requirements
• company price lists
• patient information from product monographs

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7. Disclosure/Prescribing Info. Requirements

• indications for use must conform to the
  HPB-accepted product monograph (PM)
• if no PM or Prescribing Information exists, the
  PAAB commissioner in consultation with TPP
  evaluates the disclosure
• must be presented clearly

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. . Disclosure/Prescribing Info.

• all ads for new drugs must be accompanied by Full
  Disclosure prescribing info for 2 years after
  introduction to the Canadian market
• condensed disclosures can be used after that, if
  there were no warning letters

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. . Disclosure/Prescribing Info.

• Reminder advertisements can be used instead of
  condensed disclosures
• Institutional APS
• must not contain therapeutic or other claims
• Editorial APS
• to present company opinions on current issues
• must be clearly identified as advertising

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8. Clearance Procedure and Operations

• fee required for review of APS
• PAAB preclearance review form sent with materials
• all relevant material sent in
• max review time is 30 calendar days
• material must be received 6 weeks prior to the
  presentation month
• clearance for 6 mos (12 mos without )

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Clearance Procedure and Operations

• acceptance in writing
• PAAB logo given which must be included on display
  and prescribing information
• Commissioner may withdraw clearance
• advertiser may appeal the decision

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9. Complaints and Appeals Procedures

• Complaints
• may be lodged by relevant organizations or health
  professionals
• must be in writing and include the APS
• must be signed by a senior official
• may include APS not cleared by PAAB
• intercompany dialogue is encouraged

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. . .Complaints and Appeals Procedures

• Complaints
• the advertiser must respond within 10 working
  days
• if the complaint cannot be resolved, the
  complaint is registered, and the Commissioner
  reassesses the problem
• advertiser can appeal a negative ruling

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. . .Complaints and Appeals Procedures

• Appeals to Negative PAAB Clearance
• discuss with Commissioner
• if not satisfied, appeal will go to a review
  panel
• if unsuccessful, appellant liable to pay 1500
• public reports can be made about Code violations

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10. Monitoring the Program

• Commissioner monitors all APS to determine
  whether they have received PAAB clearance
• the Board invites the full cooperation and
  participation of all advertisers, agencies,
  media, and health professionals to monitor
  various aspects of the PAAB program

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Questions?

• PRA700