Controversial diet drug tries again for approval.

On the front of its Business Day section, the New York Times (2/18, B1, Pollack, Subscription Publication) reported, "The Food and Drug Administration continues to have concerns that a weight-loss drug it is reviewing for the second time can cause birth defects and heart problems, documents released by the agency on Friday show." In 2010 the FDA rejected the drug, Qnexa, based on those concerns, and now "a committee of outside advisers to the FDA will meet on Wednesday to consider again whether the drug, developed by Vivus, should be approved." The FDA does not doubt the weight loss potential, but the Times notes the agency is becoming "increasingly concerned about assessing the tangible benefits of weight loss in terms of improving health and quality," not just how many pounds are shed. A large question the agency will consider is whether to require a clinical trial of the drug, which could delay approval for years.

        The AP (2/18) reported that Vivius "is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade," banking on the "blockbuster potential" of an FDA approval as the nation's obesity rate nears 35 percent. The AP notes, "Many analysts had picked Qnexa as the most promising contender of the new potential diet pills because of the high level of weight loss reported in company studies," with patients losing more that 10 percent of body mass. Phentermine, one ingredient in the drug, composed half of the infamous diet pill fen-phen that led to heart and lung problems, adding to concerns.

        Bloomberg News (2/18, Edney, Peterson) reported, "The FDA also plans to have advisers discuss in March the possibility of requiring heart risk studies for obesity drugs." Also covering the story were the Wall Street Journal (2/18, Dooren, Subscription Publication), Reuters (2/18), WebMD (2/18, DeNoon), and MedPage Today (2/18, Walker).