4.1 Azelaic acid

4 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #26, November 2020)

4.1 Interim decision in relation to azelaic acid

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to azelaic acid.

Materials considered

In making this interim decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to azelaic acid;
• The 129 public submissions, including seven written submissions, received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #26);
• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (f) any other matters considered necessary to protect public health;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
• The Scheduling handbook: Guidance for amending the Poisons Standard.

Summary of Joint ACMS-ACCS advice to the Delegate

The Committee recommended that the current scheduling of azelaic acid remains appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

1. the risks and benefits of the use of a substance:
   • Risks
     • Reported adverse reactions including burning/stinging, pruritus, scaling, erythema, contact dermatitis, oedema and hypopigmentation;
     • Self-diagnosis and treatment for dermatological conditions which require medical assessment.
   • Benefits
     • Effective treatment of mild-to-moderate acne and papulopustular rosacea.
2. the purposes for which a substance is to be used and the extent of use of a substance:
   • Use in cosmetics and topical creams for the treatment of mild-to-moderate acne and papulopustular rosacea.
3. the toxicity of a substance:
   • The toxicity of the substance is low, producing some eye, skin and mucous membrane irritation.
4. any other matters considered necessary to protect public health:
   • Azelaic acid cosmeceuticals are marketed online to Australians by international brands without the restrictions imposed by Scheduling. These overseas products also promote therapeutic claims of these cosmetics.

Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to retain the scheduling of azelaic acid in the current Poisons Standard, specifically not to accept the proposal to down-schedule azelaic acid to general sales level (unscheduled) in topical preparations containing azelaic acid at a concentration of 10% or less, and up-schedule therapeutic and cosmetic preparations with a concentration greater than 10% to Schedule 5. The detailed reasons for my interim decision are set out below.

I find that there is insufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling. I am not satisfied that at this cut-off azelaic acid can be supplied at the general sales level with reasonable safety and without any access to health professional advice. While azelaic acid has low toxicity, eye, skin and mucous membrane irritation can occur with reported adverse reactions of burning/stinging, pruritus, scaling, erythema, contact dermatitis, oedema and hypopigmentation. Due to uncertainty of adverse effects, I find that the risks cannot be managed with packaging and labelling in the absence of pharmacist advice.

Reasonable safety, as defined in the Scheduling Handbook^[9], requires that the consumer is able to identify and self-manage the condition for which the medicine is intended without health professional input and that the risk of the consumer confusing their condition with more serious diseases or conditions is very small. Misdiagnosis of papulopustular rosacea can occur with more serious chronic inflammatory conditions^[10], such as systemic lupus erythematosus (SLE)^[11], dermatomyositis^[12], Carcinoid syndrome^[13] and cutaneous lymphoma^[14]. I am of the view that dermatological conditions such as mild-to-moderate acne and papulopustular rosacea require the availability of pharmacist advice. I am concerned that access to azelaic acid at the general sales level, without pharmacist input, may result in self-managed treatment of dermatological conditions which require medical assessment, and for which more appropriate medications are available.

I considered the applicant's statement that the down-scheduling of azelaic acid would increase the availability of superior products widely used in the UK, US and EU in cosmetic and cosmeceuticals. At present there are two Schedule 2 products on the ARTG available in Australia containing azelaic acid at concentrations of 15% and 20%. The proposed amendment to the current Poisons Standard would up-schedule the currently available products from Pharmacy Medicines (Schedule 2) to Schedule 5, reducing the availability for the consumer. In New Zealand, azelaic acid is classified as a 'Pharmacy Only' medicine for dermal use and otherwise, it is a 'Prescription Only' medicine. The European Chemicals agency requires a hazard/warning label for products containing azelaic acid.

I have taken into account the public submissions from Ego Pharmaceuticals, The Australian Medical Association, The Australasian College of Dermatologists, The Pharmaceutical Society of Australia, Accord Australasia, and The Pharmacy Guild of Australia. These submissions noted that the application as proposed would hinder consumer availability of existing Schedule 2 products. I note, a number of these public submissions would support the down-scheduling of azelaic acid if evidence was made available to support a 10% cut-off.

Any future applications to exempt topical azelaic acid at low concentrations, should include evidence to support the cut-off concentrations. I do note that the Australian Industrial Chemical Induction Scheme (AICIS) is currently assessing azelaic acid, which may provide useful safety evidence for future consideration of this substance.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.