A group of senators hit out at Novartis subsidiary AveXis for using falsified data in the approval process of its gene therapy product Zolgensma (onasemnogene abeparvovec-xioi).
In a letter to Acting FDA Commissioner Ned Sharpless, Sens. Elizabeth Warren (D-Mass.), Bernie Sanders (I-Vt.), Dick Durbin (D-Ill.), Tammy Baldwin (D-Wis.), and Richard Blumenthal (D-Conn.) said the “scandal smacks of the pharmaceutical industry’s privilege and greed.”
The FDA announced earlier that it was investigating the firm for failing to disclose problems with animal testing data until more than a month after the product — a record-setting $2.1 million treatment for spinal muscular atrophy — was approved.