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TGA cautions drug suppliers over eye health references

A review of 13 medicines mentioning macular degeneration in Australia found all had inappropriately referenced the disease, prompting the health regulator to urge suppliers of listed medicines with eye health indications to reassess their compliance.

Last week, the Therapeutic Goods Administration (TGA) announced the findings from its targeted compliance review, which began in 2017, after consumers and industry figures signalled that some listed medicines indicated for eye health did not meet regulatory requirements.

This, according to the authority, was due to inappropriately referencing of macular degeneration and there being insufficient scientific evidence to support the indications. Macular degeneration is a ‘restricted representation’, a reference to a serious form of a disease. As such, reference to a ‘restricted representation’ in advertising requires a formal application to the TGA’s Delegate of the Secretary.

Two of the 13 medicines were cancelled at the request of the sponsor after receiving a TGA request for information. The sponsors of both medicines stated they had been discontinued and no longer manufactured. The remaining 11 progressed to review.

During the process, one medicine was cancelled before the review was completed. The remaining 10 were assessed and found to be non-compliant.

In total, the TGA stated five 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 Australian Register of Therapeutic Goods (ARTG).

As such, one of those was cancelled by the sponsor after they were informed of the issues. The labels and/or websites for the four other 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 five of the 10 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.

As a result, three of those were cancelled by the sponsor after they were informed of the issues with their medicine. The labels and/or websites for two medicines were revised by the sponsors to remove any unsupported indications relating to eye health.

Advice to suppliers

Following the review, the TGA advised sponsors of listed medicines with indications relating to the eye, and in particular the macula, are encouraged to re-assess their ARTG entry, label and advertising material and ensure their compliance with regulatory obligations.

Its advice to sponsors based on the outcome of the review is:

  1. Ensure appropriate evidence to support all indications for the medicine.
  2. Ensure prior approval from the TGA for reference to restricted representations in the advertising materials.
  3. 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.