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.
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Yesterday, FDA announced a new draft guidance “Innovative Approaches for Nonprescription Drug Products” intended to expand the range of drugs available over-the-counter (OTC).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.
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.
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.
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.
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.
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.
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”