Sales of unproven weight-loss remedies practically fly off store shelves as millions of Americans are looking for a simple fix to shed pounds. Imagine, for a moment, if a product that was scientifically proven to work was suddenly available for everyone to buy?
That is the scenario that will begin to play out in stores as the Food and Drug Administration (FDA) has given its approval for the weight-loss drug Alli to be sold over-the-counter (OTC).
The medication, which has been available for use with a doctor's prescription since it was first introduced in 1999, will be on store shelves this summer.
Dr. Arthur Frank, an obesity specialist, told The New York Times that the FDA approved Alli for OTC sale because it has a safe track record. The drug, along with proper diet and exercise, Dr. Frank said, can help patients lose five to 10 percent of their weight.
While effective, Alli, known as Xenical in its prescription drug form, has side effects such as causing diarrhea that have kept those who could benefit from the medicine from using it.
Dr. Frank said most side effects experienced by patients are the result of continuing to have too much fat in their diets. The use of Alli/Xenical requires those who take it to limit their intake of fats.
GlaxoSmithKline Consumer Healthcare, the manufacturer of the drug, will produce seven different pocket reference guides on meal-planning, fat and calorie counting and other subjects to help consumers succeed with Alli.
The company will also have a website called myalli.com to help keep consumers using the drug on track.
Steven L. Burton, vice president for weight control products at Glaxo, said the company has taken the steps necessary to help consumers lose weight safely.
"The FDA wanted us to reinforce education about the behavioral role in weight loss. They asked for more emphasis on what really are the keys to successful weight loss, steady gradual weight loss. You need to be getting more physical activity. We worked on strengthening those in the label."
GlaxoSmithKline Consumer Healthcare expects up to six million people a year will use Alli.
Discussion Questions: Rx to OTC switches have been great sales generators for health and beauty care in the past. What are you looking for with Alli going OTC? Are there "best practice" strategies and tactics that will maximize the sales of Alli and complementary products/foods when the medicine no longer requires a prescription for use?