Divided FDA Advisory Committee Votes to Require Cardiovascular Testing for New Obesity Drugs
March 29, 21012 — A panel of experts at the FDA voted 17-6 in favor of requiring all new obesity drugs seeking approval to provide phase 2 or 3 safety data ruling out excess cardiovascular risk, even if the drug does not appear to have a cardiovascular profile.The new requirements are similar to the ones put into place by the FDA in 2008 regarding diabetes drugs. The decision was devisive: Some committee members thought the cost of the additional requirement would quash research while others felt that the extra burden did not outweigh the need for safety in this class of drugs. The FDA usually follows the advice of its committees, but it does not have to. You can read the full story in the New York Times here.