5/17/2012 7:52:18 AM
Three strikes and you’re out? In 2006, the FDA noticed that Acorda Therapeutics was having difficulty submitting serious and unexpected adverse even reports within 15 days of receiving such information as required by law. The same problem was observed during yet another inspection three years later. And when the FDA returned last summer, the agency found Acorda was still failing to report adverse events when required, according to a May 10 warning letter. Acorda, however, was not just a few days late. The FDA noted there were five reports that were submitted more than 100 days past the deadline. One report described a patient who died and was due to be filed with the agency on August 28, 2010, but not received until January 10, 2011, approximately 136 days late. Other side effects that should have been reported included irregular heartbeats, arrhythmia, acute fulminant hepatitis, hypersensitivity, and memory impairment.
comments powered by