The Australasian College of Dermatologists says patient safety must come first as the RACGP pushes to overturn restrictions on GP prescribing of the acne drug.
The Australasian College of Dermatologists has welcomed the Therapeutic Goods Administration’s decision to reject a bid to allow GPs to prescribe oral isotretinoin, insisting the high-risk acne medication must remain under specialist dermatologist oversight.
The college has thrown its support behind the regulator’s interim decision, putting it at odds with the Royal Australian College of General Practitioners, which is mounting a fresh campaign to expand prescribing rights.
ACD president Dr Adrian Lim said the college had consistently advocated for specialist oversight because of the complexity of isotretinoin treatment and its potential risks.
“The College has consistently maintained that isotretinoin should remain under specialist dermatologist oversight due to the complexity of treatment and the potential risks involved,” Dr Lim told Dermatology Republic.
He said the ACD had been actively involved throughout the TGA consultation process, providing detailed recommendations aimed at keeping patient safety central to the regulator’s decision.
“We’re pleased the TGA has recognised the significant patient safety considerations associated with this high-risk medication,” Dr Lim said.
The college said it would continue advocating for a prescribing model that prioritised patient safety, clinical appropriateness and regulatory integrity ahead of the TGA’s final determination.
The response follows the TGA’s interim rejection of an RACGP application, lodged in June 2025, to allow fellows of the RACGP and the Australian College of Rural and Remote Medicine to initiate isotretinoin treatment.
The regulator cited the drug’s well-established teratogenicity among its major concerns, alongside the potential for inappropriate prescribing for mild acne and off label uses.
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The TGA also raised concerns that expanding prescribing rights could increase the risk of misuse through low-engagement telehealth and cosmetic services that might not consistently follow best-practice clinical care.
However, the RACGP is refusing to accept the interim decision and is urging GPs, particularly those working in rural and regional areas, to make submissions before the consultation deadline on 4 December.
RACGP dermatology chair Dr Tracey Purnell told Dermatology Republic’s sister publication The Medical Republic the college wanted GPs to demonstrate their ability to manage the complexities of isotretinoin treatment.
“We want to help the TGA understand the complexity of care that GPs are able to provide,” Dr Purnell said.
“The issues that [the TGA] raised about this particular medication – GPs are already educated in being able to manage those complications, and indeed, are already managing them.”
Dr Purnell said GPs were frequently responsible for monitoring patients and managing complications associated with the medication, despite being unable to initiate treatment themselves.
She argued that the current restrictions were particularly problematic for patients in regional and rural Australia, where access to dermatologists could be limited.
In Wagga Wagga, where Dr Purnell practises, she said there was only one dermatologist. Consequently, some patients were forced to travel to Sydney, Melbourne or Albury to obtain specialist care.
“When they don’t have the access, at the end of the day it is the patients who are suffering over this debate … it’s not about us being able to prescribe a drug to add it to our repertoire,” she said.
“This is about patient care and in particular, patients in in regional and rural Australia.”
The TGA acknowledged concerns about specialist access but suggested dermatologist-led telehealth services could help address geographical barriers while maintaining existing prescribing safeguards.
The regulator’s initial consultation attracted 393 public submissions, with all but 10 opposing the RACGP proposal.
Despite the overwhelming opposition, Dr Purnell said GPs were mobilising and encouraged colleagues to contribute their experiences and patient stories to the latest consultation.
“What we’d like to do is to get GPs who do feel passionately about this and who do wish to see Roaccutane available [for them to prescribe] to be involved in this process themselves,” she said.
“We’ve got to the fourth of December. If there’s a time to act, it’s now.”
For the ACD, however, the interim decision represents an important endorsement of its longstanding position that isotretinoin prescribing requires specialist oversight.
While welcoming the regulator’s decision, the college acknowledged that the consultation process was not yet complete and said it would remain actively involved as the TGA worked towards a final determination.
