Diet pill could go over-the-counter

WASHINGTON — Federal health advisers voted Monday to recommend over-the-counter sales of a weight-loss pill now sold only with a prescription.

GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill already marketed in prescription form as Xenical.

An FDA advisory committee voted 11-3 Monday to recommend approval. The agency usually follows the recommendations of its advisers, but its final decision could take months. If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales.

"We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.

When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed.

In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given a placebo. Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use would not be policed.

The proposed over-the-counter orlistat pill, called Alli (pronounced "ally"), would contain half the dose of the prescription capsule.

The pill's effect ends once its use is stopped, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products. A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, she said. Quesnelle said people could resume use or seek help from a doctor if they gain weight.

The advisers requested that the company conduct follow-up studies if and when the drug reaches the market, as well as rework the pill's label to ensure proper use, said Dr. Alastair Wood, the panel's chairman.

Glaxo said the drug helps overweight people slim down only when combined with a diet and exercise regimen. The drug's actual effect on weight loss is "gradual and modest," said Steve Burton, Glaxo's vice president of weight control.

"There is no magic pill for weight loss, and 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, the pharmaceutical company's senior vice president of research and development.

Dr. Sidney Wolfe of the watchdog group Public Citizen urged the panel to reject the company's application, calling it a "desperate attempt to revive this barely effective drug by an OTC switch."

Alli could cost consumers $12 to $25 a week, Glaxo said.