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Letter to the Editor

Editor, – Roger Goucke calls for Australian Prescriber to clarify the situation with regard to off-label prescribing (Aust Prescr 2004;27:82-3). NSW Therapeutic Advisory Group (NSW TAG)* has recently released a discussion paper to guide clinicians, policy makers and funders of health care in systematically evaluating the appropriateness of medicines proposed for off-label use.

In calling for clarification, Dr Goucke focuses his concerns on the legal issues associated with off-label use of medicines. Neither the Therapeutic Goods Administration in Australia nor the Food and Drug Administration in the USA1 regulate the use (including administration) of a medicine once it has been supplied by a product sponsor. Therefore off-label use by a practitioner (who was not a sponsor of the medicine) does not appear to be in breach of the Therapeutic Goods Act 1989 (Commonwealth) or the US Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040. Although this has not been tested in an Australian court, it has been tested in US courts and found not to breach US legislation.2

In addition to legal issues, however, clinical and ethical issues, including patient consent, also need to be considered in any decision to prescribe medicines off-label. The NSW TAG Discussion Paper highlights these issues and provides a systematic approach to addressing them. The paper may be accessed on NSW TAG's web site

* NSW TAG is an independent, incorporated association of clinical pharmacologists, pharmacists and clinicians committed to promoting quality use of medicines in public hospitals and the wider community.

Maria Kelly
Executive Officer
New South Wales Therapeutic Advisory Group (NSW TAG)

Madlen Gazarian
Senior Lecturer, School of Women's and Children's Health
University of New South Wales
Paediatric Clinical Pharmacologist and Rheumatologist
Sydney Children's Hospital, Randwick

John McPhee
Legal Academic
Honorary Associate and Honorary Senior Lecturer
Centre for Values, Ethics and Law in Medicine
University of Sydney


  1. Blum RS. Legal considerations in off-label medication prescribing. Arch Intern Med 2002;162:1777-9.
  2. Buckman Co. v. Plaintiffs' Legal Committee. 531 U.S. 341 (2001).