Healthy Skepticism Library item: 8755

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Publication type: media release

National Drugs and Poisons Schedule Committee
Scheduling of orlistat
Australian Government Therapeutic Goods Administration 2007 Feb 22
http://web.archive.org/web/20100227065615/http://www.tga.gov.au/media/2007/070222-orlistat.htm

Full text:

The National Drugs and Poisons Schedule Committee (NDPSC) reconsidered the scheduling and advertising status of orlistat (contained in the medicine Xenical) at its February 2007 meeting.

After reviewing a large number of submissions from consumer, industry and professional bodies, the NDPSC has decided that orlistat should be retained in Schedule 3 as a Pharmacist Only medicine. It has also decided to revoke the Appendix H approval that had previously been given to orlistat to allow branded advertising direct to consumers.

While acknowledging the importance of the obesity problem in Australia, the NDPSC decided that, on balance, there was insufficient public health benefit associated with allowing direct-to-consumer advertising of orlistat. Orlistat is currently only indicated for use in a relatively small group of patients with serious and significant weight problems (those with a Body Mass Index (BMI) greater than 27 with other serious diseases, or those with a BMI greater than 30), not for the general population who might wish to manage more minor weight issues.

The NDPSC noted the advice from professionals and consumers that direct-to-consumer advertising increased pressure on pharmacists to provide orlistat to consumers. This in turn had the potential to result in inappropriate patterns of use, in patients for whom orlistat was neither indicated nor appropriate.

By retaining it in Schedule 3, the NDPSC has ensured that orlistat remains available for appropriate patients with professional advice from pharmacists.

In accordance with the NDPSC’s practice and statutory requirements, a record of reasons for this and other scheduling decisions made at this meeting will be publicly available on the NDPSC website on 4 April 2007.

Media contact: Kay McNiece, 02 6289 5027