Posted by Michael Wonder on 12 Aug 2019
Democratic senators urge FDA to take action against drug company that hid faulty data
9 August 2019 - A group of Democratic senators is urging the Food and Drug Administration (FDA) to take action against a drug company that hid falsified data from the government while seeking approval for a $2.1 million gene therapy.
Senator Dick Durbin (Ill.) led the senators, which include 2020 presidential candidates Senators Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.), in pushing the FDA to take "appropriate" criminal, civil and regulatory actions against AveXis for not disclosing inaccuracies in its product testing data until after it was approved.
AveXis, a subsidiary of Novartis, knew of the issue in March, but didn't tell the FDA about it until 28 June. The drug, Zolgensma, which treats spinal muscular atrophy in infants, was approved for sale by the FDA on 24 May.
