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 . . .
Based on the dispute between Celltrion and Genentech over Celltrion’s biosimilar version of Rituxan (rituximab), it should be clear that interpretive disputes relating to the patent dance in the 2010 biosimilar law are far from over. The patent dance is indeed the gift that keeps on giving. And some of the interpretive conundrums lead to ridiculous results, at least, if you’re at all interested in saving litigants money. Look at what Genentech recently found itself doing.
As earlier posts on this blog have noted (here and here), the Supreme Court’s 2017 ruling in Sandoz v. Amgen effectively put an end to arguments that biosimilar applicants can be forced to participate in the “patent dance” with biologics innovators. Even still, there are lots of interesting issues relating to the patent litigation provisions of the 2010 biosimilars law. Here’s one percolating in the courts right now: can a biosimilar company start to dance and then change its mind? Or does it have to finish what it started?
This arises in a dispute between Genentech and Celltrion over a biosimilar copy of Rituxan (rituximab). There’s a second issue in this dispute, which I will describe in another blog post. First some background, and then I’ll unpack the litigation.
A series of thoughtful articles in the spring tackled some basic questions about the drug development and approval paradigm. I’ll be reviewing other SSRN postings in later posts, but the articles described below work well together — presenting fundamental questions about how drugs should be studied (when and by whom), how the resulting information is processed, and what information (how much and what type) should be required before drugs are permitted on the market. And they tee up what might be a spirited debate about what, exactly, a “public health” approach to new drug approval might mean.
Continuing with FDA-related scholarship posted on SSRN in February and March: Professor Noah explores the possibility of “reverse switches” from over-the-counter (OTC) status back to prescription status (or perhaps, he suggests “behind the counter” status) in response to new safety information. Professor Paradise explains the provisions of the 21st Century Cures Act that contemplate greater patient involvement in medical product development, and Professors Evans and Ossorio evaluate the 21st Century Cures Act exclusion of clinical decision software from the agency’s medical device authority.
Many scholars posted articles relating to FDA law in February and March. To do these articles justice, I am breaking my report into three parts. Below, Rachel Sachs takes on drug prices by proposing we no longer require payers to cover new drugs simply because FDA has approved the drugs; Laurie Beyranevand and Diana Winters would have the states step in where FDA has not been, in their view, aggressive enough (thus, banning substances in food that are deemed safe by their manufacturers but not reviewed by FDA, and banning use of antibiotics in food-producing animals for purposes of growth enhancement); and Robin Feldman and colleagues publish a succinct new summary of their empirical research on citizen petitions that relate to pending generic drug applications.
My last entry described the facts leading to Amgen’s suit against FDA over denial of pediatric exclusivity for Sensipar. Below I describe what’s at issue in the case. At bottom, this litigation relates to a federal agency developing a new standard (a new interpretation of its statute) that it will apply when ruling on applications for a benefit, after its prior interpretation suffered a defeat in federal court. Rather than announcing the standard publicly, the plaintiff in this case argues, the agency applied the standard in non-public rulings for more than a decade. Not only does the standard conflict with the statute, plaintiff adds, but the agency has not been consistent in its application of the standard. Thus the dispute is more about how a federal agency is operating than it is about the law of pediatric exclusivity.