GAO reviews FDA actions during heparin crisis

The U.S. Government Accountability Office released a review of FDA's management of the 2008 heparin contamination crisis. The GAO said FDA "ran the risk of undermining public confidence in the integrity of its operations" by accepting voluntary services from scientists with ties to heparin firms, including Momenta Pharmaceuticals Inc. (NASDAQ:MNTA), which had an application under FDA review at the time for a generic version of anticoagulant enoxaparin. The report noted that the external scientists had expertise and instrumentation FDA lacked that were critical to quickly resolving the public health crisis. It also concluded that although FDA had issued standards of ethics about collaboration with external entities, the agency did not have a process in place to ensure that the standards were applied when it accepted assistance from external entities with ties to heparin firms. ...