It only took a decade, but the FDA has finally issued a revised version of its 1996 draft guidance, or new rules, for testing diet pills.

This couldn’t have come a moment too late. Since that initial effort, Redux hit the market, but was recalled over links to heart and lung problems. And Xenical was better known for causing orange undies than weight loss. Moreover, these meds never helped anyone lose more than a few pounds for a few months at a time, and that was with exercise and dieting.

Now, the FDA wants to get serious. The agency proposes that patients “should have or be at significant risk for weight-related morbidity and mortality.” And drugmakers have to prove their pills can help people lose weight - and keep it off for at least a year, not a few months. Studies should also be conducted in various populations and among those with various conditions, such as diabetes. Common sense, to be sure.

But this is the same agency that says obesity is an epidemic. That’s an improper use of the word, but the point is understood. There’s a lot of fat out there and it may be hurting some people. New rules were needed a long time ago. The past two years were spent simply collecting public comments on the ‘96 proposal.

Maybe the FDA ought to bulk up.

[tags]Diet Pills, FDA[/tags]