FDA moves to two for two in rejecting yet another weight loss drug
[perplexed woman] Lorquess (lorcaserin), Qnexa (phentermine-Adapex and Topiramate-Topamax) were presented to the FDA. The FDA rejected them both. On one hand, if there is a question, we want to be safe. On the other hand, how grossly inefficient is it for a regulatory agency to ask manufacturors to hit moving regulatory targets. Why not work to establish more clearly transparent expectations for proving heart safety AND establish more clearly transparent guidelines for birth defects in rats, higher animals and dose escalations?
As it is, it appears that the FDA and manufacturors meet, establish some results criteria, then questions arise regarding safety and the company goes back to the drawing board??? One remarkable thing to be looked at: The two medicines being used in combination in Qnexa ARE ALREADY FDA APPROVED (Adapex and Topamax)--yet, there does not appear to be a press release saying that the FDA will now require the makers of the two approved versions to provide more data ???