Studies of Adverse Events

Working with a pharmaceutical manufacturer that had received a safety notice from the FDA, Analysis Group studied adverse events that may have been associated with a specific drug. Led by Managing Principal Mei Sheng Duh, the Analysis Group team studied the incidence of “QT interval prolongation” in connection with a drug for treating psychiatric disorders. Because of its potential serious clinical consequences, QTc prolongation is among the few adverse events on the FDA’s watch list, and was, in the FDA’s consideration, potentially associated with use of our client’s drug. The team, which collaborated with prominent electrophysiologists and cardiologists at Harvard Medical School to independently review and interpret the data, analyzed de-identified administrative claims data to quantify potential risk. These data allowed our team to perform numerous sensitivity analyses. Subsequently, the FDA advisory committee indicated that the study submitted by the company offered important credible evidence that the sponsor’s drug does not differ from other drugs in the same class with respect to QTc prolongation risk. The FDA advisory committee recommended that QTc prolongation will be treated as a class issue, rather than one specific to the sponsor’s product.

Applying Epidemiology to Drug Safety Investigations

 QT Interval Prolongation

Issues related to drug safety and associated risk exposure are a major focus for pharmaceutical companies. Once on the market, a drug may be the subject of an FDA investigation, which can impact both manufacturer liability exposure and product sales.

Associated Experts & Staff