Glaxo asks regulators to allow weight-loss drug without prescription

0 Comments | Philadelphia Inquirer, The, January, 2006 | by Thomas Ginsberg

GlaxoSmithKline P.L.C. asked federal regulators today to let it become the first drug company to sell a government-approved weight-loss medication without a prescription.

The London-based company, with U.S. headquarters in Philadelphia and North Carolina, told a Food and Drug Administration advisory panel it will make only modest claims about the drug - to avoid abuse - and mount an extensive education and monitoring campaign to mitigate any risks or misuse.

"Our message will not be, 'Simply pop a pill and the weight will fall off,' " Steve Burton, GlaxoSmithKline's vice president for weight control, told the panel meeting in Bethesda, Md. "The message will be, you can do it and orlistat will help."

Its proposed over-the-counter drug is a low-dosage version...