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.
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.
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.
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.
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?
Here are three more new and noteworthy articles from October and November, including Professor Robin Feldman’s new empirical study of the pharmaceutical industry.
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.
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.
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.”
Here’s what to read on SSRN, relating to FDA law, from September 2017. One piece contributes to a growing literature on the relationship between inter partes review and Hatch-Waxman litigation, and one piece dives into application of intended use doctrine to synthetic nicotine products.