Federal law requires that drug companies submit to the FDA any reports of side-effects associated with use of their products. Moreover, should the company receive any adverse event reports that are considered serious or unexpected, they must inform the FDA within 15 calendar days, as well as open an investigation into the reports themselves.
According to an October 11 warning letter, the FDA said that Jazz Pharmaceuticals, Inc. failed to submit more than 70 serious adverse event reports, over the course of seven-years, regarding the company’s narcolepsy drug, Xyrem. Alarmingly, at least 10 of the reports involved patient death. The FDA further revealed that Jazz Pharmaceutical received a similar warning back in 2007 over other adverse event reporting violations.
