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”
Here is what is new and interesting from the last two months. I’ll start with two articles on off-label promotion and two articles relating to tobacco regulation.
Continue reading “FDA Law SSRN Reading List – October and November (Part 1 of 2)”
On October 26, Senator Cruz introduced the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017” (S. 2022), which is interesting from an FDA law perspective as well as an administrative law perspective. We have seen this proposal before — in 2015 (S. 2388, introduced by Senator Cruz) and in 2016 (H.R. 6241, introduced by Congressman DeSantis). Rachel Sachs wrote about it from a policy perspective in December 2015, and Zach Brennan offered more details in his own piece the same month. I am going to dig into the details a bit more than they did and explain why I call it the “Send All the FDA Employees Home Act of 2017.”
Continue reading “Thoughts on “Reciprocal Marketing Approval””