This dubious distinction was awarded to Takeda Pharmaceuticals by Consumers International, the federation of consumer groups, for its Rozerem ad campaign in the fall of 2006. You may recall, the drugmaker ran 10-second TV ads tagged ‘Back to School,‘ which featured chalk boards, school books, a school bus, and kids with backpacks. And the ad suggested asking “your doctor if Rozerem is right for you.”

But there was a problem - Rozerem was never approved for kids. And the FDA was asleep at the school bus wheel - the agency didn’t act until this past March, when a warning letter was finally issued to Takeda. By then, of course, the school year was more than half over. Hence, the drugmaker was cited by the global consumer group for “taking advantage of poor US regulation and advertising sleeping pills to children, despite health warnings about pediatric use.”

“That such a potentially harmful drug should be geared towards young children is outrageous,” the group states. “Almost as outrageous was the token action taken by the FDA…Takeda is a $10 billion pharmaceutical company. It spent $118 million on advertising Rozerem last year, yet the FDA issued no fine and no penalty. Just a slap on the wrist. This case demonstrates the lengths to which some drug companies will go to increase sales of their products, how direct to consumer advertising can promote irrational drug use, and how weak regulation can foster irresponsible corporate behavior.”

For its creative efforts, Takeda was named the overall winner for bad drug promotion, edging out Mattel (for stonewalling Congress about its product recalls); Coca-Cola (for marketing Dasani bottled water even though it comes from the tap), and Kellogg’s (for use cartoons and product tie-ins aimed at kids who don’t need the high sugar and salt levels in the cereals). Takeda should be proud it bested such distinguished brand names.

“These multi-billion dollar companies are global brands with a responsibility to be honest, accountable and responsible,” says Richard Lloyd of Consumers International. “In highlighting their short-comings Consumers International and its 220 member organisations are holding corporations to account and demanding businesses take social responsibility seriously.”

Hat tip to Pharma Marketing Blog