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RU-486 [and] Minute to the Minister: RU-486 (Mifepristone): medical abortion.



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MEDIA RELEASE Minister for Health and Ageing

Tony Abbott MHR

15 November 2005 ABB140/05

RU-486

Because of the considerable interest in this topic, I am releasing the official advice received late yesterday on the continuing health and safety issues associated with the use of RU-486.

Media Contact: Claire Kimball, 0413 486 926

MINUTE TO THE MINISTER

MINISTER ABBOTT

RU-486 ( MIFEPRISTONE) - MEDICAL ABORTION

PURPOSE: To provide you with briefing on the drug mifepristone, also known as RU-486.

ISSUE: RU-486 (mifepristone) has been proposed as alternative to surgical abortion in women in rural and remote regions who have limited access to surgical termination services.

BACKGROUND

2. RU-486 or mifepristone is a drug used to induce abortion (referred to as medical abortion), as an alternative to surgical termination of a pregnancy. It is not currently, and has never been, registered in Australia, and no application has ever been made to the Therapeutic Goods Administration (TGA) for its marketing approval.

É It may be used alone in pregnancies of up to 49 days, or in combination with another drug, misoprostol, a prostaglandin analogue, in pregnancies up to 63 days.

É It is also used in limited circumstances for the treatment of a range of other conditions including certain types of brain tumours and endocrine conditions; for these specified purposes it is made available under Special Access Scheme (SAS) arrangements

3. Mifepristone is approved in a number of other countries.

É It was approved in the US in 2000 for terminations up to 49 days;

É Since 1991, mifepristone, in combination with a prostaglandin analogue, has been licensed for termination of pregnancy in the UK at up to 9 weeks, and since 1995, beyond 13 weeks. Surgical methods are used almost exclusively at 10-13 weeks;

É It is also used extensively in France, and in limited circumstances in NZ.

Clinical Issues

4. Mifepristone is administered orally. While its use avoids the small anaesthetic and surgical risk associated with surgical termination, it carries a significantly higher risk of later adverse events, such as incomplete termination and prolonged bleeding, and thus a higher proportion of women who undergo medical abortion require subsequent and at times, urgent intervention.

É It has been variously estimated that between 5-8% of treated women will require urgent post abortion care, some of whom will have prolonged bleeding, and some will require dilatation and curettage (D&C); in rare cases intravenous fluid resuscitation and /or transfusion may be required;

É In addition, the US FDA issued a warning in July 2005 about a risk of severe infection following four fatal cases of septicaemia in USA in a two year period. However the FDA stressed that the possible role of mifepristone and misoprostol (also given) was not known.

5. Professor Andrew Child, Director of Obstetrics and Gynaecological Services for the South Western Sydney Area Health Service, adviser to the Chief Medical Officer on obstetric and gynaecological issues, and former President of the Royal Australian College of Obstetricians and Gynaecologists has advised

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that while medical abortion is an alternative to surgical termination, its use outside the existing framework in which surgical termination is currently managed in Australia would increase the risk of adverse outcomes.

É A particular example is the routine ultrasound conducted by clinics offering termination services to confirm pregnancy, and ensure it is intrauterine, and not ectopic, before proceeding with surgical termination.

6. Professor Child believes the introduction of medical abortion using mifepristone would require extensive coordination and backup arrangements, and would be appropriate only in circumstances in which there was an established relationship with an obstetric service that could deal with emergency complications outside normal clinic hours.

É It use more broadly, for example by GP’s in rural and remote areas, would substantially increase the risks to women undergoing termination.

Registration process

7. While some clinical trials of mifepristone were conducted in Australia in the late 1980’s, no marketing application has been received by the Therapeutic Goods Administration (TGA).

É TGA cannot compel a pharmaceutical company to seek approval to market a product in Australia, and cannot approve a drug in the absence of an application.

8. An application for registration to the TGA must be submitted in a specified format, which includes the provision of detailed documentation about the conduct and outcomes of clinical trials in humans, in order to establish the product’s safety, efficacy and quality.

É The data submitted are subject to extensive review by the TGA staff and contracted clinical experts;

É A summary of the TGA’s evaluation of the application is then put to the Australian Drug Evaluation Committee (ADEC) for advice;

É On receipt of this advice the TGA delegate makes a decision as to whether the product may be registered and the conditions of that registration.

9. Under the Therapeutic Goods Act 1989 mifepristone is classified as a ‘restricted good’, and as such requires ministerial approval prior to the evaluation of marketing application by the TGA.

É This approval must be tabled in both Houses of Parliament within 5 sitting days of approval being given;

É TGA could therefore not consider an application for marketing approval should one be lodged, without prior approval.

10. If registered by TGA, restriction of the availability of mifepristone would require a recommendation of the National Drugs and Poisons Schedule Committee to the States and Territories.

É Other restrictions on use, which might possibly be recommended by ADEC or be a condition of registration imposed by the TGA, such as limitation of prescribing to medical practitioners who had undergone some form of additional training, are not usually enforceable by the Australian Government, as control of medical practice rests with the States and Territories.

COMMENT

11. RU-486 or mifepristone is a method for inducing an abortion that is associated with an increased risk of adverse outcomes over conventional surgical termination, and requires similar and in some cases even greater levels of backup

É For some women seeking pregnancy termination a medical abortion may be preferable, but is unsafe in circumstances in which appropriate supervision and follow-up may not be available

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É It is therefore unsuitable for women in rural and remote areas who may have limited access to obstetric facilities.

É Making mifepristone available, as a prescription medicine, without appropriate frameworks to ensure its safe use, would increase the risks to women undergoing pregnancy termination in this country.

RECOMMENDATION R1. That you NOTE the above.

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Professor John Horvath Chief Medical Officer Outcome: 1: Population Health Outcome 2: Access to Medicare November 2005

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TONY ABBOTT

R1. APPROVED/NOT APPROVED/NOTED

MINISTER’S COMMENTS:

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