Regulatory Policy Changes and Mifepristone Access Through Pharmacies in Australia

Importance In an effort to improve access, the Australian Therapeutic Goods Administration lifted prescribing and dispensing restrictions on mifepristone in August 2023. Mifepristone is approved for medication abortion up to 63 days’ gestation and is marketed in Australia in a combipack with misoprostol (hereinafter, mifepristone-misoprostol). The previous restrictions were similar to current restrictions on mifepristone imposed by the US Food and Drug Administration. Objective To assess whether the number and geographic distribution of pharmacies ordering mifepristone-misoprostol in Australia increased after prescribing and dispensing restrictions were lifted in August 2023. Design, Setting, and Participants This cohort study used an interrupted time-series (ITS) analysis of monthly pharmacy orders, based on sales data from the sole Australian distributor of mifepristone for the 24-month periods before (August 1, 2021, to July 31, 2023) and after (August 1, 2023, to July 31, 2025) the regulatory change. Exposure August 2023 removal of mifepristone prescribing and dispensing restrictions. Main Outcomes and Measures The primary outcome was the monthly count of unique pharmacies ordering mifepristone-misoprostol. The monthly proportion of postcodes with at least 1 ordering pharmacy was also assessed. Results Overall, 2228 pharmacies ordered mifepristone-misoprostol before the policy change and 4107 after. In August 2021, 419 (95% CI, 393-444) pharmacies ordered mifepristone-misoprostol. The number of ordering pharmacies increased by 10 (95% CI, 9-12) per month before the 2023 regulatory change. When restrictions lifted, there was an immediate increase of 86 (95% CI, 16-157) pharmacies, and the increasing trend accelerated by 15 (95% CI, 10-20) additional pharmacies per month. As of July 2025, there were 446 (95% CI, 306-581) more ordering pharmacies (48.6% increase; 95% CI, 29.2%-72.4%) than expected. In August 2021, 11.5% (95% CI, 11.1%-11.8%) of postcodes contained at least 1 ordering pharmacy, increasing by 0.2% (95% CI, 0.2%-0.2%) per month. After the August 2023 regulatory change, there was an immediate and sustained increase. By July 2025, 4.4% (95% CI, 2.4%-6.4%) more postcodes than expected had at least 1 ordering pharmacy, representing a 19.9% (95% CI, 9.9%-31.4%) increase, with the change most pronounced in major cities. Conclusions and Relevance In this cohort study of pharmacy orders for mifepristone-misoprostol in Australia, the removal of prescribing and dispensing restrictions on mifepristone in August 2023 was associated with improved access through pharmacies. These findings support removing similar distribution restrictions on mifepristone in other countries, including the US.