Listed medicines referencing macular degeneration
Macular degeneration is a restricted representation and not permitted in listed medicines.
In 2017, we initiated targeted compliance reviews for 13 listed medicines that inappropriately referenced macular degeneration. During the reviews, we determined that none of the sponsors of these medicines held sufficient evidence for the indications related to eye health.
Sponsors were required to amend the listing of these products on the Australian Register of Therapeutic Goods (ARTG) to remove any unsupported claims or cancel their product from the ARTG. No deficiencies in meeting regulatory requirements were identified that raised concerns about the safety of these medicines for consumers.
Background
What led to this review?
We received signals from consumers and industry that some listed medicines indicated for eye-health were not compliance with regulatory requirements due to inappropriately referencing macular degeneration and there being insufficient scientific evidence to support the indications.
Macular degeneration is a serious, progressive eye disease that can result in blindness. The prevalence of macular degeneration in Australia is approximately 1 in 20 people aged 65 years and over, and this increases with age to approximately 1 in 7 people aged 85 years and over.[1] In addition, approximately 10% of individuals over the age of 55 years have early age-related maculopathy, which can lead to macular degeneration. Given the severity of macular degeneration, it is a restricted representation and is not permitted for use with listed medicines.
A large study called the Age-Related Eye Disease Study (AREDS), followed by another called AREDS2, examined the effect of a number of different antioxidants and other nutritional supplements on the progression of age-related macular degeneration and cataracts. These studies recruited participants who were known to have eye disease, including early or advanced macular degeneration, which is considered a serious disease. Any reference to these studies in listed medicines is also considered a restricted representation. In addition, these studies and any others that are not performed on healthy individuals are not appropriate evidence to support claims made about listed medicines.
Action taken by the TGA
We identified 13 listed medicines on the Australian Register of Therapeutic Goods (ARTG) with macular degeneration indications or with product names that referenced or implied macular degeneration. We targeted these medicines for review based on a high likelihood of the claims not being appropriately supported by evidence held by the sponsors, or that the names of the medicines may be misleading.
As part of the review, we asked sponsors of these medicines to send us the evidence they held and assessed this against the indications and advertising claims on the product labels and website.
Two of the medicines were cancelled at the request of the sponsor after receiving our request for information. The sponsors of both medicines stated the medicines had been discontinued and were no longer manufactured. The remaining 11 medicines progressed to review.
Findings
What did we find?
During the course of the project, one medicine was cancelled before the review was completed. The remaining 10 medicines were assessed.
All 10 medicines were found to be non-compliant with regulatory requirements in relation to the indications and we ensured appropriate actions were taken to correct these deficiencies. These deficiencies and the outcomes of the corrective actions were:
- 5 of the 10 medicines reviewed referred to the restricted representation of macular degeneration either directly or indirectly, included indications that were not sufficiently supported by the evidence held by the sponsor and advertised indications that were not included on the ARTG:
- 1 medicine was cancelled by the sponsor after they were informed of the issues with their medicine.
- The labels and/or websites for 4 medicines were revised by the sponsors to remove restricted representations, any unsupported indications, and any indications made about the medicine that were not included on the ARTG.
- The remaining 5 medicines reviewed did not refer to the restricted representation of macular degeneration, but included indications that were not sufficiently supported by the evidence held by the sponsor:
- 3 medicines were cancelled by the sponsor after they were informed of the issues with their medicine.
- The labels and/or websites for 2 medicines were revised by the sponsors to remove any unsupported indications relating to eye health.
What did the TGA do?
Since March 2018, indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of low risk indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor. There is no longer a free-text field for sponsors to enter their medicine indications when they apply to list their medicine in the ARTG.
Introducing the list of permitted indications provides transparency on what indications are suitable for listed medicines to help prevent sponsor non-compliance and provides greater protection for consumers from misleading and inappropriate claims.
Indications referring to macular degeneration are not included in the list of permitted indications. Some lower level indications relating to the eye are included where they meet the eligibility criteria for low risk indications. These lower level indications require that the product presentation does not imply or refer to serious eye diseases such as macular degeneration.
Information for sponsors
Sponsors of medicines who did not hold adequate evidence to support indications suitable for listed medicines were required to update the ARTG entry, labels and advertising material for their medicines to bring them into compliance. We are able to initiate further compliance reviews at any time if we become aware of further compliance issues with these or other medicines making restricted representations relating to macular degeneration.
All sponsors of listed medicines with indications relating to the eye, and in particular the macula structure of the eye, are encouraged to re-assess their ARTG entry, label and advertising material and ensure their compliance with regulatory obligations. Our advice to sponsors based on the outcomes of these reviews is:
- Ensure you hold appropriate evidence to support all indications for your medicine.
- 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.
- Ensure prior approval from the TGA for reference to restricted representations in the advertising materials.
- Any reference to the Age-Related Eye Disease Study (AREDS) 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.
- Remember that unacceptable presentation of a medicine includes:
- referring to unsupported indications on the labels and any other advertising material
- having a name that implies a therapeutic benefit not supported by evidence
- having any statements on the label or any advertising material that may mislead consumers to believe the medicine possess characteristics it does not have.
You can make changes to the listing of an affected medicine via TGA Business Services.
Please refer to the Listed medicines application and submission user guide for guidance on this process.
Any changes to your medicine's entry on the Australian Register of Therapeutic Goods (ARTG) must also be reflected on the medicine's label and any advertising material.