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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FDA Law SSRN Reading List – December ’17 & January ’18

Very few folks posted papers in December and January relating to FDA law, but hopefully the February law journal submission cycle will yield a rich crop.  Here are two essays and one article of potential interest – one each on medical devices, biological products, and food.  (I am excluding my own paper.)

Sarah Duranske, Reforming Regenerative Medicine Regulation

In this article forthcoming in the Georgia State Law Review, Duranske (currently a fellow at Stanford) (* edited to correct the spelling of her last name!) evaluates proposals for regulation of regenerative medicine.  She has several interesting ideas tucked in here, any of which could have been the basis for an article in its own right.  Section I contains a nice overview of the current regulatory paradigm for therapies that fall within the umbrella of “regenerative medicine” — including the recently enacted accelerated approval pathway for “regenerative medicine advanced therapies.”  Section II responds to deregulation arguments, arguing that FDA regulation is necessary to protect patients and to ensure the development of meaningful data.  Much of this retreads familiar ground, but the discussion of “Baptists and bootleggers” alliances with respect to regenerative medicine is very interesting.  This phenomenon is pervasive in food and drug law and merits more discussion in scholarship.  Section III is where the article gets interesting.  Here, she considers proposals for “adaptive licensing” of regenerative products.  The basic idea is that FDA would approve a product on the basis of less evidence, but would restrict access while the sponsor gathered more evidence from clinical use.  She characterizes adaptive licensing as a type of adaptive management — a particular type of process that an agency might use to produce a regulatory outcome. She then assesses the suitability of regenerative medicine for adaptive licensing by running it through the various rationales in the administrative law literature for adaptive management at agencies.  This leads her to the conclusion that the benefits of adaptive licensing do not outweigh its risks.  Section IV contains a brief discussion of her proposals — for instance, shifting some regenerative therapies to the more loose regulatory paradigm governing human tissue and cell products.  But I wanted to read much more about her ideas.

Jane R. Bambauer, Dr. Robot

In this essay published in the UC Davis Law Review, Professor Bambauer considers whether health and medical artificial intelligence (AI) should be regulated more like physicians or medical devices.  When the application is a “knowledge” app rather than a “measurement” app, she argues, physicians are the better analogy.  Some of the duties of a physician (such as the duty of competence and the duty of confidentiality) translate well, but she is more guarded about other rules (rules of informed consent, for instance, and the duty to disclose conflicts of interest).

Laurie Beyranevand, Regulating Inherently Subjective Food Labeling Claims

In this essay published in Environmental Law, Professor Beyranevand essentially argues that FDA should ban claims like “natural” and “healthy” in food labeling.  The statute imposes clear rules governing specific types of claims, such as “health claims” and “nutrient content claims.”  She is focused on claims that are not covered by these specific claims-authorizing provisions of the statute.  And she argues that FDA should subject these claims to a standard of “significant scientific agreement” — that is, permitting them only if there is significant scientific agreement.  The FDCA already uses this standard for health claims, which generally characterize a specific relationship between a food product and a health condition or disease.  She also believes it would be virtually impossible to support a claim like “natural” and “healthy” under this standard.  So, in essence, she is arguing for a ban.  Finally, although the federal courts have concluded that the First Amendment requires FDA to consider disclaimers for health claims that lack significant scientific agreement, she contends that the First Amendment is no impediment to the proposal.  I think the idea is that if a claim is inherently subjective, then a disclaimer isn’t going to clear things up (there’s x amount of data, but not y).  It’s just going to confuse consumers more.

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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Food Additive Approvals — and Patents

I spend a lot of time thinking about the intersection of FDA regulation and intellectual property, and I have been constructing a large dataset relating to the patents claiming different types of FDA-regulated products.  Recently, I have also been thinking a great deal about the regulation of food (because Mizzou is now allowing me to teach Food Law & Policy, in addition to Drug & Device Law).  These two areas of interest intersected this past week, giving me some modest insights into premarket review of food additives and some very modest data to contribute to discussions about the (in?)efficiency of FDA’s food additive review process.

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You Can Dance if You Want To

On December 14, the Federal Circuit handed down the latest decision in the dispute between Sandoz and Amgen concerning the process for patent litigation under the Biologics Price Competition and Innovation Act amendments to the Public Health Service Act (PHSA). The matter was on remand from the Supreme Court. Judge Lourie, writing for a unanimous panel, concluded that Sandoz had not waived its argument that Amgen’s state law claims were preempted by federal law and, moreover, that those state law claims were indeed preempted.  A dive into the decision below, with apologies for the length. Continue reading “You Can Dance if You Want To”

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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Thoughts on “Reciprocal Marketing Approval”

On October 26, Senator Cruz introduced the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017” (S. 2022), which is interesting from an FDA law perspective as well as an administrative law perspective.  We have seen this proposal before — in 2015 (S. 2388, introduced by Senator Cruz) and in 2016 (H.R. 6241, introduced by Congressman DeSantis).  Rachel Sachs wrote about it from a policy perspective in December 2015, and Zach Brennan offered more details in his own piece the same month.  I am going to dig into the details a bit more than they did and explain why I call it the “Send All the FDA Employees Home Act of 2017.”

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