The Puzzling Uncertainty about Umbrella Exclusivity

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.

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Whither FDA’s drug approval paradigm? — A Debate from Recent FDA Law SSRN Postings

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.

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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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SSRN Reading List February and March, 1 of 3

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.

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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.

FDA Law SSRN Reading List (August 2017)

Here’s a round up of FDA-law related readings posted to SSRN in August.

This excludes articles that were published before 2017 but posted on SSRN for the first time in August 2017.  It also omits pieces for which the abstract, but not the article, was posted.  As a result, for instance and unfortunately, it does not include Professor Jordan Paradise’s new piece, Regulatory Silence at the FDA: Impact on Drug and Biologic Competition.  The abstract indicates she explores the agency’s “reluctance” to wade into issues relating to patent law as well as the contribution of this “silence” to anti-competitive action that harms consumers.

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ANDAs before Hatch-Waxman

Three times in the last two weeks, I have found myself explaining to someone that the Hatch-Waxman Amendments did not create the abbreviated new drug application for generic drugs.  For that matter, there were generic drugs long before 1984, and there was a generic industry long before 1984.  And that’s not even the most interesting part; at one point, FDA drafted a regulation for an ANDA pathway that would apply in the future to new NDAs and that would provide a 17-year exclusivity period.

This blog entry explains a little of the history.

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FDA Law SSRN Reading List (July 2017)

I plan to capture monthly the papers posted on SSRN that relate directly to FDA law (other than those written by me or Patti).  Here is the July 2017 edition.

Michael Carrier, Carl Minniti, and Brenna Sooy, Five Solutions to the REMS Patent Problem, forthcoming in Boston University Law Review.  There have been a number of articles exploring whether and to what extent innovators are somehow inappropriately benefiting from the access restrictions imposed by FDA under a “Risk Evaluation and Mitigation Strategy” (REMS).  Professor Carrier’s piece (co-authored with two students) makes a contribution by diving more deeply into one specific issue — the fact that several innovators with access restrictions hold patents claiming an aspect of the REMS.  Table 1 helpfully lists the 23 patents associated with REMS for five innovative products, which the authors found in the Orange Book.  The authors believe that a generic company seeking to copy a drug with a REMS protected by patent will be “stuck between the rock of FDA law and hard place of patent law” — essentially that the generic company will have no choice but to infringe.  They offer five solutions. First, they argue that REMS patents should not be listed in the Orange Book — which as a practical matter would mean that a generic applicant would not have to challenge it and (more importantly) that the patent could not give rise to an automatic 30-month stay of generic drug approval.  Second, they suggest that REMS patents may be invalid and urge use of inter partes review.  Third, they argue that in the event of infringement, an injunction should not issue.  Fourth, they propose amendments to the REMS provision of the FDCA that they believe will prevent REMS patents from blocking generic competition; the article helpfully includes the legislative language in question.  Finally, they propose that the patent act be amended so that risk management methods and systems are insufficient to differentiate a claimed invention from the prior art.  (Professor Carrier also posted slides that he presented at FDA’s recent hearing on the Hatch-Waxman Amendments; here, too, he offers proposals relating to REMS.)

Lindsey M. Edwards, The Need for Clarification on Product Hopping: Open Questions after Namenda and Doryx.  Ms. Edwards is a 2017 graduate of the Antonin Scalia Law School and will be joining Wilson Sonsini in the fall.  This brief piece published by the ABA Section of Antitrust Law summarizes two leading cases on “product hopping,” which she defines as making “an incremental change to the formulation of a drug in order to extend its exclusivity period.”  In very simple terms (mine, not hers), the allegation of “product hopping” arises when an innovator that has been marketing Brand 1.0 of its product introduces Brand 2.0.  Under the FDCA, a generic copy of Brand 1.0 can still be approved exactly when expected, but the concern arises when, for one reason or another, physicians and patients have switched to innovator’s Brand 2.0.  Generic drug companies generally rely on automatic substitution (under state pharmacy law) to achieve market penetration — meaning the automatic substitution of Generic 1.0 when a physician writes a prescription for Brand 1.0.  If physicians are now prescribing Brand 2.0, that won’t happen.  There can be variations and nuances to this basic fact pattern, and there are strongly held views on both sides of the question whether anything anti-competitive has happened.  Ms. Edwards describes two significant recent cases that came out differently in the courts of appeals (one involving Namenda and one involving Doryx), and she spends some time discussing what the courts analyzed differently (the importance of state substitution law to market penetration being one of them).

August will bring many more articles to read.

The Unapproved Drugs Conundrum

In recent years there have been a few high profile situations in which the price of a medicine has jumped sharply and suddenly, after decades of availability at a much lower price.  In some of these cases — like the case of gout treatment colchicine, which went from 10 cents to five dollars per pill in 2011 — the sudden price increase relates to FDA’s “unapproved drugs initiative.”  This refers to the agency’s approach to removing unapproved new drugs from the U.S. marketplace.

This blog entry explains the back story and the public policy conundrum that merits some attention.

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Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Notice & Comment and Stanford’s Law and the Biosciences Blog.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

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