Panel Backs Diet Pill’s Sale Over the Counter

WASHINGTON — Federal health advisors 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. The FDA in 1999 approved the prescription version of the fat-blocking pill made by Roche.

A joint FDA advisory committee voted 11 to 3 to recommend approval late Monday after a daylong hearing. The agency usually follows the recommendations of its outside panels of experts, but its final decision could take months. If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales. Roche will continue selling Xenical regardless.

“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.

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.

When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat -- the equivalent of about 150 to 200 calories -- is passed out of the body in stools, which can be loose or oily as a result. Other side effects include gas, incontinence and oily spotting. About half of patients in trials experienced such side effects, the company said.

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.

“I think the drug is safe enough to be OTC,” panel chairman Dr. Alastair Wood said after the vote. “Although there are some I’s that need to be dotted and Ts crossed, it’s suitable for OTC use.”

The panel requested that the company conduct follow-up studies if the drug does reach the market, as well as rework the pill’s label to ensure proper use, Wood said.

Glaxo said the drug helps the overweight slim down only when combined with a diet and exercise regimen. The proposed pill, called Alli (pronounced “ally”), would contain half the dose of the prescription capsule and could cost consumers $12 to $25 a week, Glaxo said. The company estimated 5 million to 6 million Americans a year would buy the over-the-counter drug. Those numbers could mean at least $1.5 billion a year in retail sales.