FDA Considers Faster Approval Process for Obesity Drugs
October 11, 2012 — In a major breakthrough for people looking for new and effective treatments for obesity, Bloomberg/Business Week reports that the FDA is considering a pathway that would allow drugs like those for obesity or life-saving antibiotics that are deemed to offer societal benefit despite their risks to get speedier approval, according to FDA Commissioner Margaret Hamburg in tape released today by the agency. "The FDA needs to better account for the needs of patients with deadly or debilitating diseases who may be willing to accept the additional perils of unproven drugs," Hamburg said.FDA consideration of an expedited process appears to build upon a report released in August by the the George Washington University School of Public Health, A range of obesity experts participated in a nine-month process that produced this consensus, to help guide the FDA in evaluating the benefits and risks of potential new obesity drugs. The process included senior FDA officials as observers. Until this summer, when the first two new obesity drugs in over a decade were approved, obesity experts had been frustrated with the way the FDA had been approaching the approval of new treatments for people with excess weight or obesity.
You can read the whole story on Bloomberg/Business Week here. You can read about the work of the George Washington University expert panel here.