February 27, 2007
OTC orlistat DTC ads banned in Australia
Drugmaker Roche has been banned from advertising the OTC version of its weight-loss drug Xenical (orlistat) directly to consumers in Australia, due to concerns about unsafe use of the drug.
The move comes after controversial TV ads for the drug aired during a popular youth program, “Australian Idol,” prompting criticisms that Roche was targeting teenage girls, the Australian news Web site theage.com reported.
The Australian National Drugs and Poisons Schedule Committee, which made the decision this week, said the advertising was increasing pressure on pharmacists to sell the products, which could lead to inappropriate use.
“While acknowledging the importance of the obesity problem in Australia, the (committee) decided that, on balance, there was insufficient public health benefit associated with allowing direct-to-consumer advertising,” a committee spokeswoman told the theage.com. The spokeswoman said the drug was appropriate only for patients who were very overweight and had a serious health problem or who were obese, but not for the general population “who might wish to manage more minor weight issues.”
Aaron Hall, a spokesman for the Pharmaceutical Society of Australia, an advocacy organization for pharmacists, said he believed most pharmacists were following the guidelines on how the drug is to be sold.
“Advertising an over-the counter drug in itself is not a bad thing.” Hall told theage.com. “The devil is always in the detail.”
Earlier this month, the FDA approved a version of orlistat to be sold as an OTC weight-loss aid for overweight adults in the US.
The US version will be sold under the brand name Alli by GlaxoSmithKline in a 60 mg dose and is indicated for use in adults ages 18 years and older, in conjunction with a reduced-calorie, low-fat diet, and exercise program, the FDA said.
Alli is scheduled for launch in June.