As FDA has noted, artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform healthcare. These technologies could be used at the agency, by other agencies involved in healthcare regulation and finance, by private participants in the healthcare delivery system, and by medical device manufacturers. They can also be embedded in conventional medical devices or, indeed, serve as standalone medical devices. For several years now, FDA has been exploring how its existing medical device framework applies, or should be adapted to apply to, software “as” a medical device as well as software “in” a medical device. In this post, I review four recent law review articles exploring legal and policy issues presented by the emergence of artificial intelligence and machine learning in medical devices and the healthcare setting more generally.Continue reading “Artificial Intelligence & Machine Learning: Recent Scholarship”
Recent Scholarship: FDA and Other Regulators
As readers know, FDA does not operate in a vaccuum; it has relationships with, and sometimes collaborates with, other federal regulators. It shares information with them, it may receive information from them, and sometimes it shares jurisdiction with another agency or shares responsibility for implementing a particular program. (For instance, both PTO and FDA play a role in implementing the patent term restoration provisions of section 156 of the Patent Act. Some of my work explores the FDA/PTO intersection.) Today I highlight two recent pieces of scholarship focusing on FDA and other regulators. Both, I think, reflect the same notion; as Professor Tammi Etheridge (who writes the second article) says, this work “belies the notion that all agency collaboration is good collaboration.”Continue reading “Recent Scholarship: FDA and Other Regulators”
The Tradeoffs Involved in New Drug Approval, Expanded Access, and Right to Try
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”
Vaccine Approval 101
Here’s a tutorial on the usual process for vaccine development, testing and approval, for folks tracking the new coronavirus (COVID-19). In brief: it will take a while and very large clinical trials to get a coronavirus vaccine approved at FDA. But preapproval testing is likely to happen on the ground where the coronavirus is spreading, and there is a potential for expanded access (to the unapproved vaccine) in the meantime.Continue reading “Vaccine Approval 101”
Emergency Use Authorizations
Here’s a quick tutorial on the “emergency use authorization” (EUA) process at FDA, for folks following the coronavirus. This explains in a little more detail the information that Dr. Gottlieb posted in a Twitter thread earlier today.Continue reading “Emergency Use Authorizations”
SSRN Reading List . . . or Device Regulation: What Role for Tort Law?
The 2020 annual conference of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (at Harvard Law School) will focus on the future of medical device regulation. If you’re interested in participating, abstracts are due on October 14, final papers are due March 27, and the conference is May 8. (Here’s a link to the call for papers.) I’m working on an empirical project relating to device premarket approval and patent term restoration, but sadly the dataset won’t be ready in time. Meanwhile, here’s a run-down of some interesting legal scholarship on medical device regulation in the last year and a half.Continue reading “SSRN Reading List . . . or Device Regulation: What Role for Tort Law?”
FDA’s Abandoned Proposal to Require Reporting of Data Falsification
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”
The Big “Data Manipulation” Story
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”
Case To Watch: Eagle v. Azar’s Hidden Chevron-Step-1 Issue
Recently I spoke at the annual meeting of the Food and Drug Law Institute (FDLI) on Eagle v. Azar, which is currently on appeal to the D.C. Circuit. At first blush the case seems of limited importance, because Eagle Pharmaceuticals is simply challenging FDA’s interpretation of statutory language that has since been amended. But reading through the litigation papers reveals a more interesting disagreement between the parties, about what a court should consider, when assessing whether a statute clearly answers a particular legal question. I will unpack this after the jump. Warning: this is more of an essay than a blog post. I start with a TL;DR.Continue reading “Case To Watch: Eagle v. Azar’s Hidden Chevron-Step-1 Issue”
Changes in the new Orange Book — or, too much time on my hands …
It’s always an exciting day when FDA issues the new annual edition of the Orange Book! (At least for me, and I’m sure also for Kurt Karst, over at FDA Law Blog.) There are a lot of changes in store at the Orange Book in the next year, all of which will get fanfare and attention, but this post is about the little changes in the annual edition (print and PDF) that don’t get called out. It’s prompted by the fact that FDA deleted a sentence in the preface last year, without telling anyone. (I had quoted it in an expert report, just a few months earlier and was annoyed to see it deleted.) I resolved that going forward I would electronically compare every new annual edition to the last year’s edition, and so I spent my Saturday doing exactly this with the new edition — and crashing my computer repeatedly. The results after the jump.Continue reading “Changes in the new Orange Book — or, too much time on my hands …”