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.

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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.

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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. 

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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. 

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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  Three days later a group of Senators wrote FDA a letter asking, among other things, why the agency had withdrawn a proposed regulation that would have required “sponsors of certain clinical trials to promptly report suspected data falsification to FDA.”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.

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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.

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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.

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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.

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Patent Term Restoration – Denied!

In 1984, Congress amended the Patent Act to permit a patent extension for certain types of inventions — many (but not all) of those subject to premarket testing and federal government approval requirements.  Some people call this patent term extension; others call it patent term restoration.  Between enactment of the statute in September 1984 and the end of March 2017, the Patent and Trademark Office received 1113 applications for patent term extensions in connection with new drugs and biological products.  But by April 1, 2018, it had granted only 664 extensions.  Why do companies not get patent term extension?  Usually because this wasn’t FDA’s first approval of the active ingredient. 

More after the jump.

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SSRN Reading List; Genetically Modified Food and the Public’s Voice

Anyone who teaches Food Law & Policy knows that “genetically modified food” will get all the students participating and bring out some passion in the classroom.  As the National Academies of Sciences pointed out in their 2016 report, Genetically Engineered Crops (see pages 48-51), public opinions are very strong and range from intense opposition (on the view that genetically modified food is “extremely risky”) to strong support (“overwhelmingly beneficial”) even though, as NAS pointed out, most Americans nevertheless do not know much about genetic engineering as it relates to agriculture.  Continue reading “SSRN Reading List; Genetically Modified Food and the Public’s Voice”