Cannabis and the Often Overlooked Drug Exclusion Rule

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 . . .

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Opening Up the OTC Market

Cross-posted on Stanford’s Law and the Biosciences Blog

Yesterday, FDA announced a new draft guidance “Innovative Approaches for Nonprescription Drug Products” intended to expand the range of drugs available over-the-counter (OTC). Specifically, the agency’s proposal indicates a willingness to make available OTC drugs for certain historically prescription-only therapeutic categories—such as overdose reversal drugs, like naloxone, or cholesterol-lowering drugs. As I told a journalist yesterday, overall I see this as a positive step—and one that is consistent with long-standing interest in making more drugs available without a visit to a physician, including interest at the state and local level.

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FDA Law SSRN Reading List – February and March 2018, 2/3

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.

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Pediatric Exclusivity (3 of 3): Amgen v. Hargan

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.

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Pediatric Exclusivity (2 of 3): Amgen v. Hargan

A prior post provided an overview of pediatric exclusivity — how it works and why it was designed this way.  This is the first of two posts describing Amgen’s suit against FDA regarding the agency’s denial of pediatric exclusivity for Sensipar (cinacalcet hydrochloride).  I’ll start, today, with the back story — the facts and Amgen’s complaint.

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Pediatric Exclusivity 101

Shortly before Alex Azar’s confirmation hearing (to be Secretary of HHS), a reporter called me with questions.  She had an angle she wanted to pursue: that Lilly had “gamed” a patent, using pediatric exclusivity, under Azar’s watch.  I explained pediatric exclusivity – what it was designed for, how it works, and how Lilly seemed to have used it precisely as designed. I mentioned the constraints that apply to company requests for pediatric exclusivity and told her that they were meaningful, mentioning Amgen’s ongoing litigation against FDA regarding exclusivity for Sensipar.

My explanation had little impact; the story ran as initially conceived.  Judge Moss ruled in the Sensipar dispute in late January, however, and Amgen has confirmed that it plans to appeal the ruling.  This is therefore the first of two posts on the issue of pediatric exclusivity.  Below I explain how pediatric exclusivity works; in the next post I will explain the Sensipar dispute.

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Decoding FDA’s Statement on DIY Gene Therapies

Cross-posted on Stanford’s Law and the Biosciences Blog

In late November, FDA posted a statement on its website about the “self-administration of gene therapy”—which various media outlets interpreted as a reaction to some companies recently posting videos of consumers “self-experimenting” with gene therapy. One question that arose in some of the reporting—and in an exchange on twitter—is, what is FDA’s authority to regulate do-it-yourself (DIY) gene therapy?

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FDA Law SSRN Reading List – October and November (Part 2 of 2)

Here are three more new and noteworthy articles from October and November, including Professor Robin Feldman’s new empirical study of the pharmaceutical industry.

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FDA Law SSRN Reading List – October and November (Part 1 of 2)

Here is what is new and interesting from the last two months.  I’ll start with two articles on off-label promotion and two articles relating to tobacco regulation.

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What to Make of Substantive Objections to FDA’s Intended Use Revisions?

Cross-posted on Stanford’s Law and the Biosciences Blog

As I have previously written about here, in January FDA published a controversial revision to its regulations defining “intended use,” and then, in the wake of procedural and substantive objections to the revised definition, the agency delayed the effective date of the new rule until March 2018.  These revisions are important because the “intended use” of a product is crucial for determining whether the product is a drug or device subject to FDA jurisdiction at all, and if so, whether the drug or device is in compliance with various FDA requirements.  Accordingly, there is significant interest in the kinds of evidence that FDA considers relevant to determining a product’s intended use.  The January revision to FDA’s regulations explained that that FDA would use a “totality of the evidence” approach to determining intended use, which would permit the agency to look to “any relevant source of evidence,” including, perhaps most controversially, a manufacturer’s knowledge about consumers’ and patients’ actual uses of the product.  The procedural “logical outgrowth” arguments against this standard do not persuade me for the reasons I explained here.   Likewise, I am not sure the substantive arguments against the revised regulations convince me.

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