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 are three more new and noteworthy articles from October and November, including Professor Robin Feldman’s new empirical study of the pharmaceutical industry.
Continue reading “FDA Law SSRN Reading List – October and November (Part 2 of 2)”
What are people recommending that FDA do, to improve the current balance between drug innovation and access to generic drugs? The docket isn’t closed yet, but I’ve read the first 67 comments. . . .
FDA held a public meeting in July to consider the Hatch-Waxman Amendments, asking for comment concerning its administration of the amendments “to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.” It also opened a docket for written comments, which was originally slated to close on September 18. On September 19, it extended the date for submission of comments to November 17. What follows is a high level overview of some of the main recommendations for FDA in the first 67 comments.
Continue reading “Hatch-Waxman Comments – Status Report (Part I)”