While acknowledging that isotretinoin is a very effective treatment for severe acne, the TGA was concerned that the risks of expanding prescribing outweighed the benefits.
Isotretinoin is currently listed as a Schedule 4 poison and can only be prescribed by specialist physicians and dermatologists.
“The overwhelming majority of submissions highlighted the risk of teratogenicity, the clinical complexity of safe and appropriate initiation and monitoring (including the need for robust pregnancy-prevention measures), the potential for misdiagnosis of mimicking conditions … and the potential for inappropriate use in patients with non-severe disease,” the TGA’s delegate explained in their rationale.
Of the 393 public submissions in response to the proposed change, 383 were opposed, 5 supported, and 5 partially supported.
The RACGP argued that with shortages of dermatologists in rural and regional areas, restrictions are creating a barrier to timely, effective treatment.
At the time the College launched its proposal in August 2025, a Healthed poll of 1447 GPs found doctors were split with a slight majority in favour of removing restrictions. Just over half (54%) thought GPs should be allowed to prescribe isotretinoin, while 46% said the restrictions were appropriate. In contrast, 97.5% of the submissions to the TGA opposed lifting the restrictions.
The submissions have not yet been made public, but the RACGP supported its own proposal, and the Australian College of Dermatologists has been on the record opposing it.
Several GPs in Healthed’s survey who supported the change said the cost of seeing a specialist was prohibitive for some patients. Others pointed to a contrast between other medicines GPs are permitted to prescribe.
“Absolutely ridiculous if we are prescribing schedule 8 drugs every day for pain and now expected to manage ADHD in general practice,” yet not able to initiate isotretinoin, one GP commented.
“It’s frequently requested by patients. Long wait to see dermatologist. Expensive for young patients to see specialist. Monitoring as a GP is straight forward and we tend to have easier access to follow up,” another GP in the survey said.
In the interim decision, the TGA delegate summed up that “The small number of public submissions that supported or partially supported the proposal contended that permitting appropriately trained general practitioners (GPs) to initiate isotretinoin may improve access, particularly in rural and remotes areas, and enhance continuity of care.”
Between 20 to 35% of pregnancies exposed to isotretinoin resulted in irreversible birth defects, including craniofacial, cardiovascular, and neurological malformations.
The regulator noted that the UK, USA, Europe and Canada have restricted prescribing for the acne medication. New Zealand has broadened accessed, but evidence about safety outcomes is limited, though “available data may indicate an increase in isotretinoin-exposed pregnancies as a result of broader prescribing,” they said.
“While the evidence is not conclusive, it does not provide assurance that broader initiation prescribing can be implemented without compromising safety,” the TGA delegate stated.
They also said they shared the advisory committee’s concerns that allowing GPs to initiate treatment “may increase the risk of inappropriate prescribing for mild acne and other off-label uses, and also the risk of misuse through low-engagement telehealth and cosmetic services that may not consistently apply best practice clinical care.”
The association with psychiatric adverse outcomes, liver injury and severe acne flare-ups were also noted.
Several GPs in Healthed’s survey said GPs should be able to initiate the drug as long as they completed additional training requirements – and this was also suggested in the College’s proposal, as well as submissions that supported it.
One GP said they supported expanded prescribing “With increased education for all GPs regarding pre-treatment screening and information provision to patients and their families about the treatment.”
However, the TGA “robust evidence to demonstrate equivalent safety outcomes was not provided,” adding that there was no plan for a training framework to ensure existing safeguards were maintained.
The RACGP called the interim decision ‘deeply disturbing,’ saying it did not adequately recognise GPs expertise or the significant access issues patients face. RACGP president Dr Michael Wright emphasised that the decision is not yet final and there is still time for GPs to share their perspective.
The College will address the concerns raised by the TGA in a submission and encouraged individual GPs to respond to the TGA as well.
The consultation is open until close of business on 4 December 2026. “All submissions received by the deadline will be considered by the delegate before they make a final decision,” the TGA said.
Prescribing should be expanded
“GPs already manage contraception, mental health, drug interactions, drug liver test monitoring. One could argue GPs are more qualified than dermatologists.”
“GPs are seeing their patients frequently and know them much better than dermatologists.”
“Nurses and pharmacists are taking up GP roles, why so many restrictions on GPs.”
“It would be practical and helpful for patients who cannot afford seeing or waiting to see a dermatologist. Not to mention the expenses.”
“With good instruction about side effects and potential teratogenic effects by the GP, I cannot see why GPs cannot prescribe this drug.”
“GPs should be allowed to prescribe with further training.”
“Many patients, especially in rural or underserved areas, face long waits to see dermatologists. GPs already manage long-term follow-up for other chronic conditions and could integrate acne care within the same framework. Early treatment of severe acne can reduce scarring, psychosocial impact, and long-term morbidity.”
“Would suggest GPs can be equally as competent as dermatologists in assessing the need … at a much reduced cost to the patient.”
Prescribing should remain restricted
“High risk of significant adverse reactions.”
“Dermatologists are better qualified to deal with any possible side effects.”
“Often specialist involvement is valuable to the patient and reinforces the value of the treatment.”
“If we have higher numbers prescribing isotretinoin, then we will get higher associated suicide rates (causal or not, just based on numbers) and then the drug company might pull the drug off the market, which will be a disaster, because it’s such a great drug for many hard-to-treat acne cases.”
“I would not trust GPs to be as conscientious as specialist dermatologists. Pregnancy catastrophes are more likely to occur as a result of unnecessary loosening of prescribing restrictions. N.B. The prescribing of isotretinoin is never an emergency. Patients can wait for an appointment with the specialist. An unintended pregnancy in the context of isotretinoin is, however, a medical catastrophe. The latter must be avoided at all costs.”
“I think there are advantages of dermatologists managing isotretinoin, the only obvious limitation is the shortage of dermatologists and a tendency for them to focus on procedural medicine rather than non-malignant skin conditions where they are needed.”
It’s complicated
“GPs with special interest should be able to prescribe isotretinoin. Personally, I do not want to prescribe this drug and would continue to refer to a specialist as I am not confident that I would prescribe and follow up correctly.”
Comments are from Healthed’s August 2025 survey when the RACGP first submitted its application to expand prescribing to GPs.
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