In September the FDA issued a warning letter the the drug company Actelion Pharmaceuticals for failure to report on deaths of 3,500 patients who died while on the drugs Tracleer or Ventavis, used to treat pulmonary arterial hypertension.
The letter follows a 2009 inspection of the company. “The inspection focused on Actelion’s compliance with Postmarketing Adverse Drug Experience (PADE) reporting requirements relating to the following drug products: Tracleer® (bosentan), NDA 21-290; Ventavis® (iloprost), NDA 21-799; and Zavesca® (miglustat), NDA 21-348.”, said the letter
THe letter cited Actelion for, “Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA…These deviations resulted in Actelion’s failure to report approximately 3,500 patient deaths reported to Actelion in connection with Tracleer® and Ventavis®, without an adequate basis for not reporting them.”
Addressing Actelion’s reporting proceedure, the FDA was not pleased. “These reporting procedures are in violation of the Act because they allow Actelion to presume that there is no relationship between a death and Tracleer® even when Actelion has no information at all about the possible relationship. There is, however, a “reasonable possibility” that Tracleer® contributed to a death if there is no information to suggest otherwise. In addition, the procedures do not require Actelion to make a meaningful effort to obtain information about the relationship between a death and Tracleer® at all, much less within a timeframe that would enable Actelion to meet its 15 calendar day expedited reporting obligations were a reasonable possibility that the drug caused a death to be found.”