Targeted project: Macular degeneration

14 June 2017

Macular degeneration is a restricted representation and not permitted in listed medicines.

Macular degeneration

Eye

What will we review?

We will examine the unauthorised reference of macular degeneration in listed medicines.

When will it start? Is my medicine included?

If your medicine is included in the targeted project, we will write to you in July 2017 and request information such as your product label and the evidence you hold to support claims and indications.

What should I do now?

As a sponsor, you are encouraged to:

  1. Ensure your indications are not directly or indirectly referencing macular degeneration
  2. Re-evaluate the evidence you hold to ensure it supports your indications
  3. Consider if your product name is potentially misleading within the context of your goods

What will happen after the review?

  • If your listed medicine is compliant there will be no further regulatory action.
  • If your listed medicine is found to be non-compliant, regulatory action will follow and the medicine may be cancelled from the ARTG.
  • A summary of the outcomes from this targeted review will be published in due course.

Reasons for initiating the project

  • Macular degeneration is a serious disease affecting 1 in 7 Australians over the age of 50[1] and can result in blindness.
  • The severity of macular degeneration ensures it is a restricted representation for listed medicines.
  • We have signals from consumers and industry that some eye-health products inappropriately reference macular degeneration.

Footnotes

1. Mdfoundation.com.au. (2016). Macular Disease Foundation Australia - Risk Factors. [online] [Accessed 8 Dec. 2016].

What will we assess?

1. Indications

Indications and claims on the label and website must not reference macular degeneration. We will carefully assess indications to ensure;

  • they do not directly or indirectly reference macular degeneration
  • they are supported by appropriate evidence

Macular degeneration

Macular degeneration is a serious disease, and classified as a restricted representation. Any direct or indirect reference to macular degeneration requires an exemption from the TGA, or otherwise will be subject to compliance action and potential cancellation from the ARTG.

The macular

Indications or claims that simply reference the macular as a part of the eye might be appropriate for listed medicines, as long as they are supported by appropriate levels of evidence. The Evidence Guidelines provide more detail on evidence requirements for indications.

Case study:

  • The following indications refer to health benefits that go beyond general health and wellbeing. Such indications should be supported by higher levels of evidence, for example clinical studies:
    • 'Lutein may help protect the macular region of the eye from light damage'
    • 'Helps reduce the risk of damage by free radicals in the macular region of the eye'
  • The following indications refer to health and wellbeing and would not require the same level of evidence as above:
    • 'Supports the health of the macular region of the eye'
    • 'Provides antioxidants known to help support general eye health'

The ARED 1 and ARED 2 studies.

  • Any reference to the ARED studies is considered a restricted representation.
  • The ARED studies were performed on patients with a serious disease and looked at clinical outcomes regarding the treatment and prevention of macular degeneration.

2. Name of the medicine

  • The name of a medicine must not mislead consumers to self-diagnose or inappropriately treat macular degeneration.
  • This includes omissions or emphasis that may indirectly imply the medicine is able to treat or prevent the onset of macular degeneration.

What's in a name?

  • A product name that does not directly reference macular degeneration may still be non-compliant if the advertised indications or images reference or imply macular degeneration.
  • This is because the name may be viewed in a different context alongside suggestive indications or images present on advertised materials like the webpage or label.

Case study:

  • A product called 'MacEyes'
    • This product name may be acceptable if the product has general indications which do not imply or reference macular degeneration.
    • This product name may not be acceptable if the product website references the ARED studies.
  • A product called 'HealthyEyesight'
    • This product name may be acceptable if the product has supported specific indications which do not imply or reference macular degeneration.
    • This product name may not be acceptable if the label or website has indications or graphics suggestive of macular degeneration. In this case, the context of the goods has changed the interpretation of the name.