This note explains some of the concepts swirling around in the media right now, relating to medicine approval. Much of what follows appears (or will appear) in an article on the U.S. “right to try” law, which I recently wrote with a colleague at the University of Bourgogne in Dijon, France. Some of the background discussion will be useful here.Continue reading “The Tradeoffs Involved in New Drug Approval, Expanded Access, and Right to Try”
On August 6, FDA announced that Novartis’s application for approval of Zolgensma contained “manipulated” data and that the company knew this while the application was pending, but did not tell the agency. Three days later a group of Senators wrote FDA a letter asking, among other things, why the agency had withdrawn a proposed regulation that would have required “sponsors of certain clinical trials to promptly report suspected data falsification to FDA.” It may be helpful to review the concerns that people raised. Details after the jump.Continue reading “FDA’s Abandoned Proposal to Require Reporting of Data Falsification”
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”