One of the big end-of-summer news stories at FDA is the agency’s August 6 statement that Novartis submitted “manipulated” data to support approval of its gene therapy product, Zolgensma. According to FDA, Novartis knew about the manipulation before FDA approved the product, and yet the company didn’t disclose the manipulation to the agency until June 28 — more than a month after approval.
A group of Senators (including Presidential hopefuls…) has said the company’s “greed” cannot be condoned and that FDA should hold the company accountable for its “malfeasance.” They have also asked FDA why it withdrew a proposed regulation requiring companies to report data falsification.
I take you through a brief tour of the publicly available information, after the jump. In my next post, I’ll explain the abandoned data falsification reporting proposal.Continue reading “The Big “Data Manipulation” Story”