Compliance with advertising requirements...fulfilling the sponsor's reporting requirements. 21 Title Compliance with advertising requirements Author Therapeutic Goods Administration

Compliance with advertising requirements

Mick O’Connor Director, Recalls and Advertising Section Office of Product Review Monitoring and Compliance Group CHC Regulatory Obligations Seminar – 16 June 2014

Outline of presentation • Overview of the Therapeutic Goods advertising

requirements

• TGA advertising initiatives to improve consistency

• TGA’s approach to advertising compliance

• Advertising tips and pharmacovigilance reporting requirements

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Therapeutic Goods Advertising Requirements • The advertising requirements are set out in the

‒ Therapeutic Goods Act ‒ Therapeutic Goods Regulations ‒ Therapeutic Goods Advertising Code ‒ Price Information Code of Practice

• Advertising requirements are also set out in the Competition and Consumer Act

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Therapeutic Goods Act 1989 Chapter 1- Interpretation

• Advertisement -

“...any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods”

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Therapeutic Goods Act 1989 - Chapter 3

• Subsection 22(5): Offence for Medicines

‒ Advertising unapproved indications

‒ Applies to all

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Therapeutic Goods Act 1989 Chapter 5; Part 5-1 – Advertising

• Provides for:

‒ exemption for advertisements directed towards health professionals

‒ advertising definitions ‒ establishes the Advertising Code ‒ prohibited and restricted representations

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Therapeutic Goods Act 1989 Chapter 5; Part 5-1 – Advertising • Publishing or broadcasting offences:

‒ unapproved advertisements or those that differ “in any respect” from what was approved

‒ advertisements with prohibited / restricted representations and government agency recommendations

‒ advertisements for unapproved products

Therapeutic Goods Regulations 1990 • Part 2

‒ establishes approval scheme for certain “specified media” advertisements

‒ provides for the TGA to issue orders

•

Part 6, Divisions 2 & 3 ‒ establishes TGACC & CRP and their

procedures ‒ provides for the complaints register

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Therapeutic Goods Advertising Code

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• The Code is a legislative instrument made by the Minister under section 42BAA of the Act

• The Code is consistent with the WHO Ethical Criteria on Medicinal Drug Promotion

The Role of the TGA • Administers the legislation which underpins

the advertising framework

• Oversight of shared regulatory arrangements with CHC and ASMI

• Initiates further regulatory action to obtain advertising compliance where required

• Chair of TGACC

• Observer on complaints panels

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Consultation RIS • Consultation 31 May -

19 July 2013 • 1276 submissions were

received • Any changes to the

advertising arrangements to be considered within the broader government deregulatory framework

Goal = truth in advertising • A robust and effective system of

advertising controls − Ensures responsible advertising − Reinforces the quality use of therapeutic

goods − Provides for consumer confidence and trust − Enhances the health outcomes of all

Australians

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Advertising initiatives • Regular teleconferences are held with Advertising

Services Managers to – Improve consistency in decision-making between the

ASMs, CRP and the TGA – Revise the advertising approval form and prepare

supporting instructions – Develop a series of ‘information papers’ and ‘fact sheets’

on key advertising topics

TGA’s Approach to Compliance

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Regulatory Compliance Framework Published June 2013

Advertising Compliance • Complaints Resolution Panel (CRP) may

request the advertiser to take certain actions

• The Panel may make a recommendation to the Secretary to the Department of Health (TGA) ‒ where the Advertiser fails to respond, or

fails to indicate an intention to comply fully with Panel’s requests

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Recommendations to Secretary • The Panel may recommend that Secretary

orders the Advertiser to

‒ withdraw an advertisement ‒ withdraw claim or representation ‒ publish a retraction or correction

• May also recommend that the Secretary take other regulatory actions

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The Secretary’s Order • Secretary’s delegate in TGA reviews afresh

the complaint and the Panel’s findings

• If the Panel’s recommendation is accepted the delegate orders the Advertiser under regulation 9 to

‒ withdraw an advertisement ‒ withdraw claim or representation ‒ publish a retraction or correction

• Consequences of non-compliance with order and rights for ‘review’ advised

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Publication of regulation 9 orders

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Advertising Tips 1. Hold the appropriate level of evidence 2. Claims must be consistent with approved

indications 3. No references to prohibited conditions,

unapproved restricted representations, "TGA approved“ or to the product being safe

4. Advertisements are approved where required 5. Endorsements and testimonials must comply

fully with the Code

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Pharmacovigilance reporting requirements • Requirements are outlined in the Australian

requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines which can be found on the TGA website at http://www.tga.gov.au/safety/australian-pharmacovigilance-sponsors-00.htm

• In summary, sponsors of medicines on the Register are expected to collect, record and analyse adverse event reports they receive.

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Pharmacovigilance reporting requirements • Specific requirements include the requirement to

report to the TGA:

‒ A significant change in the risk/benefit of your product within 72 hours

‒ All serious adverse reaction reports within 15 calendar days from the day received

‒ Non-serious adverse reaction reports if requested

• Sponsors of medicines on Register are also required to advise the TGA of the name of its pharmacovigilance contact person responsible for fulfilling the sponsor's reporting requirements.

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