GSK: Diet pills need FDA scrutiny

What's a surefire way to win a contest? Keep your opponent from showing up, of course. That's what GlaxoSmithKline is trying to do [1] in the over-the-counter weight-loss market. The drugmaker has petitioned the FDA for more regulation of the supplements, namely, that any product making weight-loss claims should be subject to agency approval--or disapproval. Under current guidelines, diet pills don't have to undergo any clinical trials before they're let loose at a drugstore or supermarket near you.

Of course, GSK's Alli product is a lower-dose version of the Roche med Xenical. It's the only FDA-approved diet drug sold over the counter. If the agency required all the others to submit to clinical trials, Alli would have the field to itself--unless and until other products' claims were substantiated by hard data.

In its petition to the FDA, Glaxo brought the obesity epidemic to bear, saying that society can't afford to let overweight Americans rely on ineffective products. The American Dietetic Association and two other groups are backing GSK's bid. Predictably, trade associations for supplement makers are less than thrilled. The FDA and FTC already crack down on companies that make fraudulent or misleading weight-loss claims, they say. "It is already impermissible to sell snake oil," one supplement industry attorney told the Star-Ledger. But GSK is using the number of FTC crackdowns to bolster its case, saying that this proves consumers have been victims of fraudulent products. We'll see what the FDA says, probably by year's end.

- read the Star-Ledger article [2]
- see the story [3]in Drugstore News

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