Reasons for PBAC denial of women’s testosterone therapy released: “inequitable” and “scientifically flawed”

MEDIA RELEASE – Embargo 12.00 am, 27 March 2026

Reasons for PBAC denial of women’s testosterone therapy released: “inequitable” and “scientifically flawed”

Last Friday, 20 March 2026 the Commonwealth Pharmaceutical Benefits Advisory Committee (PBAC) published its rationale for not recommending an Australian-developed, Australian-registered and Australian-manufactured female-specific testosterone product for listing on the Australian Pharmaceutical Benefits Scheme (PBS).

AndroFeme 1 testosterone cream was approved by the Therapeutic Goods Administration (TGA) in 2020 for the treatment of distressing low libido in postmenopausal women, medically termed hypoactive sexual desire dysfunction (HSDD). Registration of AndroFeme 1 by the TGA was approved based on the TGA’s extensive evaluation of the product’s quality, safety and efficacy.

Lawley Pharmaceuticals, a Perth-based company, founded by medical director and pharmacist Michael Buckley, considers the PBAC’s refusal to be “scientifically and logically flawed”, and ultimately “inequitable to women”.

The PBAC’s publication last week and its 20 December 2025 initial announcement included the following statements:

• “clinical data did not show that testosterone was more effective than placebo, or as safe, for the relevant patients”
• “HSDD is not an effect of menopause”
• PBAC “had difficulty in defining the medical condition”
• PBAC “questioned the clinical place of testosterone therapy”

In Lawley’s view, in purporting to make such findings, the PBAC has usurped the TGA evaluation and approval process.

“What is the point of having the TGA if PBAC can simply stray beyond its jurisdiction and inappropriately purport to re-evaluate matters of efficacy and safety that are properly within the TGA’s statutory and policy remit? The TGA has already done that, through a far more comprehensive evaluation process than the PBAC undertakes”, said Mr Buckley.

“The PBAC provided no opposing science, no contrary safety data, no logic and not a shred of evidence to validate this negative decision,” he said.

“It’s obviously not a pricing issue as we were requesting up to 75% less per day than what the PBS currently pays for some of the eight testosterone products on the PBS for men. As a matter of gender equity, it simply doesn’t pass the pub-test – Australian women continue to have no PBS-subsidised testosterone option and their voices are just being ignored”.

International Women’s Day was celebrated earlier this month with the theme ‘Give to Gain’.

Also released on the same day was a report from a UK parent advocacy group titled Medical Misogyny: a lifetime of failure, the cover page of which quotes the current UK Secretary of State for Health and Social Care, Wes Streeting, who acknowledged just last month:

“I have seen it in the NHS I lead. From victims of some of the worst scandals to women such as a close female relative, whose severe pain was ignored by a male doctor, not once but twice until her male partner vouched for her pain. Even the NHS, founded on the principles of equality, ignores women’s voices and experiences.”

Sadly, Australia’s government and health reimbursement system is not immune to the undervaluing of women’s health.

Lawley is seeking judicial review of the PBAC’s decision in the Federal Court of Australia.

Read PBAC’s published decision here. Backgrounder on Lawley’s rebuttal available here.

Media enquiries contact Anna Lensky anna@pitchprojects.com 0425 766 780

Interviews with experts and women with lived experience available upon request.