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 Three days later a group of Senators wrote FDA a letter asking, among other things, why the agency had withdrawn a proposed regulation that would have required “sponsors of certain clinical trials to promptly report suspected data falsification to FDA.”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”
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”
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 …”
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.Continue reading “Patent Term Restoration – Denied!”
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”
In late August, two professors — from George Washington University Law School and Lund University (in Sweden) — uploaded a fascinating article proposing that plant milk companies stop fighting for the right to call their products “milk” and instead embrace the disruptive term “mylk” in order to disassociate their products from oppression and exploitation linked to dairy milk. It’s a very interesting read, and it turns out to be very timely . . . because one month after they posted their article, FDA issued a notice asking for comments on the naming of these products . . . . after a summer in which the media and social media decried imminent “censorship” of names for plant-based foods. I lay this out — and discuss the article — after the break.
Cannabis in my brownies and crickets in my soup today. All good, as far as I am concerned, but the food law and policy issues are fun to chew on. Monday I will post about two more recent food law and policy articles, one relating to genetically modified food (really pertaining to agency use/misuse of guidance documents) and the other a fascinating read on gender and race aspects of the debate over plant “milk.” For the weekend, though, cannabis and crickets.
In the middle of July, FDA announced a public hearing on facilitating competition and innovation in the biologics marketplace. Following the hearing, September 4, comments were accepted in the docket (FDA-2018-N-2689) until last Friday, September 21.
The agency’s Federal Register notice listed a series of questions, but one of them struck me — at the time — as surprising. FDA asked for comment on the “potential application” of “umbrella exclusivity” for biologics. Why surprising? Because I would not have thought it controversial. More than five dozen comments have been filed, though, and at least one company (Mylan) has argued that the statute doesn’t permit the umbrella.
So it seems like it might be timely to back up and explain this.
Earlier this week, several major news outlets (CNN, Fox Business, and Bloomberg) reported that Coca-Cola is considering making a move into “cannabis drinks” — as evidenced by supposed talks with Aurora Cannabis, Inc., a Canadian owned and operated company that sells a variety of cannabis products including several strains of dried cannabis as well as several oils. The company finally issued a statement, in response to many media inquiries: “We have no interest in marijuana or cannabis. Along with many others in the beverage industry, we are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world. The space is evolving quickly. No decisions have been made at this time.”
Caution might well be warranted with respect to products for sale in the United States, because of the often-overlooked drug exclusion rule at FDA. Coca-Cola has sophisticated FDA counsel, and I am sure they are on top of this issue. But others watching legal and real-world developments relating to sale of cannabis may not be aware of the rule, which presents a significant legal impediment to the sale of CBD in any form other than approved new drugs (even if no medical claims are made).
Many people don’t know about the drug exclusion rule . . .