Sloppy seconds I know I'm always telling you not to believe everything you read, and if I hadn't read it from numerous sources (ones I've come to respect and trust) I wouldn't believe it myself. But it looks like the FDA has actually made a sound decision for once -- one based on the best interests of human health and safety and not on its own back pocket. It rejected Merck's proposed replacement for its now-disgraced arthritis darling Vioxx. Of course, the new drug, Arcoxia, would probably be on the market right now if the whole Vioxx scandal hadn't erupted a few years ago. Arcoxia was already on the FDA's waiting-for-approval list when Vioxx was linked to increased risk of heart attack and stroke. Since Arcoxia is in the same drug class as Vioxx, the FDA decided to try and save a little face by insisting the Merck provide further safety and efficacy information on the new drug before it would consider approving it. Apparently, what Merck came back with must have been really unconvincing for Big Pharma's best friend to still give it the axe. That doesn't necessarily mean we can say good riddance to bad rubbish once and for all, though. Arcoxia is available in over 60 other countries, and Merck is determined to add the U.S. to that list, saying that they're "committed to working with the FDA to determine the best approach to get it on the U.S. market." But for now I'll take what I can get and enjoy this moment, however fleeting it may be, of feeling as though the FDA is actually doing the job it's supposed to. |