Mifepristone (RU 486) registered for use in Australia

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Mifepristone (RU 486) registered for use in Australia

Posted 31/08/2012 by Amanda Biggs

Australian Government - Department of Health - Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA), the regulator of medicines and therapeutic devices in Australia, has announced that from 29 August 2012 the abortifacient mifepristone (RU 486) will be listed on the Australian Register of Therapeutic Goods (ARTG). Misoprostol, a drug that can be used in conjunction with mifepristone but already available in Australia, has also been approved for use in medical abortion. Medical abortion is a method of pregnancy termination that involves the administration of a drug or drugs to induce an abortion, and is distinct from surgical abortion.

The approval of mifepristone follows the successful application by Marie Stopes International Australia (Marie Stopes), a national provider of sexual health and family planning services, to have it registered for pregnancy termination. Registration on the ARTG means that mifepristone is now allowed to be marketed and sold in Australia, although potential prescribers must still abide by the laws on abortion in their jurisdiction.

Since 2006, when a Ministerial veto on its use in Australia was lifted (for background, see this Parliamentary library publication), mifepristone has only been available through the TGA’s Authorised Prescriber Scheme. Under the Authorised Prescriber Scheme a medical practitioner who wants to prescribe mifepristone must apply to the TGA for permission to import the drug and is required to administer it under strict conditions and with ethical oversight.

Prior to 2006, mifepristone was classified as a ‘restricted good’ which could only be imported into Australia with written Ministerial approval. While not a direct ban, this restriction effectively discouraged potential sponsors from seeking approval, as it ensured any application to import the drug would attract considerable political attention. With the passage of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 (see the Bills Digest for details), the Ministerial authority to approve the importation of mifepristone was removed. This meant that in line with other drug approvals it was the responsibility of the TGA to assess the efficacy, safety and quality of mifepristone if any application for registration was made.

However, at the time Ministerial authority was removed no sponsor undertook to apply for registration of mifepristone, so it remained accessible only through the Authorised Prescriber Scheme. It has been suggested that the small size of the Australian market, the political history surrounding the drug and Australia’s abortion laws have contributed to sponsor reluctance. As of August 2012, 187 medical practitioners had obtained authorisation to prescribe mifepristone for pregnancy termination. Listing on the ARTG according to the TGA statement, means that medical termination will now be available to a wider group of Australian women.

Mifepristone has been approved for use in a number of countries, including the United Kingdom, the United States, much of Western Europe, Russia, China, Israel, New Zealand, Turkey and Tunisia. It works by blocking the effects of the hormone progesterone, which is crucial to starting and maintaining pregnancy. The prostaglandin misoprostol is then administered, which induces uterine contractions and results in the expulsion of the contents of the uterus. Mifepristone is mainly administered in the first trimester of pregnancy; the TGA has approved its use in the first 7 weeks of pregnancy.

While termination using mifepristone is generally regarded as being a safe procedure, the death of an Australian woman from sepsis in 2010 who was prescribed the drug did raise some questions over patient care. Data from South Australia, which is one of the few jurisdictions that mandates reporting of abortion statistics, reports the complication rate for the 669 mifepristone/misoprostol induced terminations undertaken in 2010, was 5.2 per cent (mainly due to the contents of the uterus being retained). This rate of complication was higher than for surgical abortion (0.5 per cent), but lower than for other medical methods (administration of other prostaglandins orally or vaginally). According to the TGA statement, since going onto the Authorised Provider Scheme, 792 reports of adverse events associated with mifepristone have been provided to the TGA (and one recorded death due to sepsis).

As the sponsor, Marie Stopes has undertaken to include a tailored educational package for medical practitioners who seek to prescribe mifepristone. Only those medical practitioners who have completed appropriate training as approved by Marie Stopes will be able to prescribe and administer the drug (although Fellows and Diploma holders of the Royal Australian and New Zealand College of Obstetricians and Gyneacologists will not have to complete the training). Supply of mifepristone will also be provided through Marie Stopes. The registration of mifepristone is also conditional upon the sponsor undertaking a post marketing study that must include the reporting of any serious adverse events associated with mifepristone such as retained products, bleeding and infection.

Listing on the ARTG does not mean the drug automatically goes onto the subsidised medicine list, the Pharmaceutical Benefits Scheme (PBS). A separate application for listing must be made to the independent evaluator, the Pharmaceutical Benefits Advisory Committee. News media have reported that Marie Stopes is considering applying for a PBS listing.

The listing of mifepristone is likely to remain controversial, given its past history in Australia and the ongoing opposition to abortion among a proportion of the Australian population. Reports of any adverse events associated with its wider availability will be scrutinised, as will the role of the TGA in overseeing its safety and efficacy. Whether it’s listing on the ARTG will have broader impacts, including on the legal status of abortion in the states and territories, may depend on it establishing a record of safety and efficacy.

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