"There is no magic pill for weight loss and Alli (orlistat) is not a magic pill. Orlistat is a tool that will help people control their calorie intake and modify their diet," said John Dent, GSK's senior vice president of research and development. John proposed that the OTC version of Alli (pronounced "ally"), would contain half the dose of the prescription capsule.
Two FDA advisory committees were to vote on recommending approval late Monday.
The agency usually follows the nonbinding recommendations of its outside panels of experts.
An earlier, internal FDA review found the drug is a "safe and effective weight loss agent," but held off on concluding whether it should be sold without a prescription.
The review found that over-the-counter use of the drug could lead to vitamin deficiencies and encourage abuse.
On Monday, FDA panel members questioned whether consumers would be able to distinguish Alli from non-approved dietary supplements also sold as weight-loss aids. They also expressed concern about its effect on vitamin intake.
Public Citizens' Dr Sidney Wolfe, urged the FDA not to deregulate the medicine. His presentation can be seen here:
http://www.citizen.org/documents/orlistat_testimony_wolfe.pdf
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