Category: Health Law

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FAN 70.1 (First Amendment News) Amarin v. FDA –Important Commercial Speech Case May be Decided Soon

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug and device approval processes. Critics, however, have long contended that the FDA’s position violates the First Amendment to the extent it prohibits truthful speech. — Evelien Verpeet, ReedSmith, June 18, 2015

Should pharmaceutical companies be able to advertise drugs for uses not  approved by the FDA? It seems like a no brainer — of course not! But as with so many other things in life and law, the answer (especially the First Amendment answer) is not so obvious.

→ The caseAmarin Pharma, Inc. v. United States Food & Drug Administration (Dist. Ct., S. Dist. NY).

→ Judge: The matter was argued before U.S. District Judge Paul A. Engelmayer on July 7, 2015. A ruling is expected soon.

Unknown5→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”

U.S. Atty. Preet Bharara

U.S. Atty. Preet Bharara

→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions. But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses. — David B. Rivkin Jr. &  Andrew Grossman, WSJ, May 21, 2015

 P’s Counsel: Floyd Abrams is the lead counsel for the Plaintiff with Joel Kurtzberg and Michael B. Weiss (see here re P’s complaint)

→ Gov.’s CounselPreet Bharara is the attorney for the Defendant along with Ellen London and Benjamin Mizer

→ Amicus Briefs: Pharmaceutical Research and Manufacturers of America and Washington Legal Foundation — both in support of the Plaintiff / Public Citizen in support of the United States

→ FDA Letter to Judge Engelmayer, June 8, 2015 (see here for a discussion of the mootness issue raised by this letter)

Excerpts from United States v. Caronia (2nd Cir. 2012) re off-label promotions 

The government’s construction of the FDCA asprohibiting off-label promotion does not, by itself, withstand scrutiny under Central Hudson’s third prong [that the regulation directly advance the government’s interests] . . . . The last prong of Central Hudson requires thegovernment’s regulation to be narrowly drawn to further the interests served. . . Here, the government’s construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests. . . . We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. Judge Denny Chin for the majority.

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[T]he majority calls into question the very foundations of our century-old system of drug regulation. I do not believe that the Supreme Court’s precedents compel such a result. . . . If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses. — Judge Debra Ann Livingston dissenting

Summary of Amarin’s First Amendment Arguments Read More

Corporate Experimentation

Those interested in the Facebook emotional manipulation study should take a look at Michelle N. Meyer’s op-ed (with Christopher Chabris) today:

We aren’t saying that every innovation requires A/B testing. Nor are we advocating nonconsensual experiments involving significant risk. But as long as we permit those in power to make unilateral choices that affect us, we shouldn’t thwart low-risk efforts, like those of Facebook and OkCupid, to rigorously determine the effects of those choices. Instead, we should…applaud them.

Meyer offers more perspectives on the issue in her interview with Nicolas Terry and me on The Week in Health Law podcast.

For an alternative view, check out my take on “Facebook’s Model Users:”

[T]he corporate “science” of manipulation is a far cry from academic science’s ethics of openness and reproducibility. That’s already led to some embarrassments in the crossover from corporate to academic modeling (such as Google’s flu trends failures). Researchers within Facebook worried about multiple experiments being performed at once on individual users, which might compromise the results of any one study. Standardized review could have prevented that. But, true to the Silicon Valley ethic of “move fast and break things,” speed was paramount: “There’s no review process. Anyone…could run a test…trying to alter peoples’ behavior,” said one former Facebook data scientist.

I just hope that, as A/B testing becomes more ubiquitous, we are well aware of the power imbalances it both reflects and reinforces. Given already well-documented resistance to an “experiment” on Montana politics, it’s clear that the power of big data firms to manipulate even the very political order that ostensibly regulates them, may well be on the horizon.

“They Cannot Breathe:” Poisoned Workers in Nail Salons

The grim story of deregulation in the US economy has another victim: nail salon workers. A New York Times expose has won tremendous attention to their plight in an industry that has long resisted regulation:

Some states and municipalities recommend workers wear gloves and other protection, but salon owners usually discourage them from donning such unsightly gear. And even though officials overseeing workplace safety concede that federal standards on levels of chemicals that these workers can be exposed to need revision, nothing has been done. So manicurists continue to paint fingertips, swipe off polish and file down false nails, while absorbing chemicals that are potentially hazardous to their health. . . .

In interviews with over 125 nail salon workers, airway ailments . . . were ubiquitous. Many have learned to simply laugh them off — the nose that constantly bleeds, the throat that has ached every day since the manicurist started working.

For those interested in the legal background, I highly recommend a piece by my former student, Kelsey-Anne Fung. In 2014, she concluded:

Southeast and East Asian immigrant nail salon workers face disproportionate exposure levels to dangerous and carcinogenic nail products, and as a result, suffer severe health outcomes at unusually high rates. Without FDA authority of pre-market approval, testing, or recall, the cosmetic industry is wholly self–regulated, resulting in scarce protections to consumers and professions who use nail products on a daily basis. Salon owners often pay below minimum wage, do not provide health insurance or any benefits, and fail to supply adequate safety equipment. Consequently, workers must rely on community safety net clinics and public hospitals for medical care to treat ailments from working in the nail salon, paying steep out–of–pocket rates. On its own, the Patient Protection and Affordable Care Act does not remedy any of the health policy issues facing immigrant nail salon workers. Thus, [state-level interventions] may be the only viable solution to securing preventative and affordable health care services for this overburdened and vulnerable labor force.

Both Fung’s article, and the NYT piece, are must-reads for anyone concerned about the fate of workers in an increasingly deregulated environment.

 

 

 

New Podcast: The Week in Health Law (TWIHL)

Nicolas Terry and I are starting a health law podcast, The Week in Health Law, and the first two episodes are posted here. We were honored to have Nicole Huberfeld on as our first guest. Check it out on iTunes, Stitcher, or your favorite podcast app.

Next week we’ll be talking with Abigail Moncrieff the day after King v. Burwell oral arguments. Later guests this month include Lindsay F. Wiley (on wellness programs) and Erin C. Fuse Brown (on health costs).

The Care/Profit Tradeoff in Health Care

The tradeoff is an old theme here, and of continuing relevance.  Via Yves Smith, news of a settlement related to investors’ role in pushing for quick gains in a firm:

As Hospira was promising to address issues raised by the U.S. Food and Drug Administration following inspections, the plaintiffs said the company was “making the problems worse by gutting quality control efforts through cost cutting aimed at boosting short-term profitability.” The lawsuit said those cost-cutting moves stemmed from a March 2009 initiative called “Project Fuel” intended to increase shareholder value by eliminating underperforming . . . units and reducing its global workforce.

The goal of immediate maximization of “shareholder value” is increasingly under attack,  even by its ostensible masters.  Add “Project Fuel” to that fire.

 

Gluck on Halbig

The tough luck constitutionalists are pushing another line of attack on the Affordable Care Act.  As Abbe Gluck recently observed,

Health care reform won a big victory in court on January 15, when a federal judge in Washington, D.C., rejected a challenge to the new health insurance marketplaces, or exchanges, created under the Affordable Care Act (ACA). . . . [T]he court rejected as unsupported by the ACA’s history the argument that Congress viewed the subsidies as a “carrot” to induce the states to run the exchanges (and so had no need to provide them on the federal exchanges). Although today there is great “red state” resistance to the exchanges, when the ACA was drafted, congressional advocates for states’ rights clamored to let the states run them, and no one assumed that they wouldn’t. The fact that Congress failed to foresee today’s political environment doesn’t change what it originally intended.

For those interested in the appeal, Gluck has posted today on the challengers’ farrago of “kitchen-sink arguments, many of which are incompatible with the basic principles of statutory construction on which their briefs purport to rely and which evince a misunderstanding of the ACA’s procedural history.”  

Infinite Punishment

Can a society that pours ever more resources into “guard labor” be truly innovative? It turns out that yes, we can:

Philosopher Rebecca Roache is in charge of a team of scholars focused upon the ways futuristic technologies might transform punishment. Dr Roache claims the prison sentence of serious criminals could be made worse by extending their lives. Speaking to Aeon magazine, Dr. Roache said drugs could be developed to distort prisoners’ minds into thinking time was passing more slowly. “There are a number of psychoactive drugs that distort people’s sense of time, so you could imagine developing a pill or a liquid that made someone feel like they were serving a 1,000-year sentence,” she said.

Manipulating the subjective experience of punishment used to depend primarily on external factors, like cell size, terms of socialization, or lighting. An emerging pharma-prison complex could bring a whole new level of efficiency to the guard labor sector. Would our courts recognize such a drug as “cruel and unusual?” Considering the terms of confinement now routinely accepted in the American prison system, that’s anyone’s guess.

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Health as a Bottleneck

In his thoughtful and path-breaking book, Bottlenecks: A New Theory of Equal Opportunity, Joey Fishkin challenges the common conception of equal opportunity as providing a level playing field.  He explains that merely equalizing opportunity at critical points in a person’s life, such when she applies for a desirable job or college program, is often not enough. By then, social inequities and previous limited opportunities may have already taken their toll on the affected individuals, perhaps leaving them underprepared and ill-equipped to meaningfully compete—let alone succeed—even when given the chance.  Fishkin explains that this line of reasoning puts us in a vicious cycle: To achieve true equal opportunity, interventions must happen earlier.  But when is earlier?  The disadvantaged job applicant could have benefited from a better college education.  Yet the disadvantaged college student could also have benefited from a better high school education.  And the disadvantaged high school student could have benefited from a better primary school education. And the disadvantaged primary school student could have benefited from having parents with higher incomes and more time to devote to parenting, which just takes us back to the disadvantaged job applicant.  Hence, Fishkin identifies a key flaw in the traditional construction of equal opportunity: We are all the products of our opportunities, and those opportunities can never be truly “equal.”  To that end, he endorses “opportunity pluralism,” which he defines as making more opportunities available to more people.  Thus, in a society that limits educational or job opportunities based on a particular standardized test, we can move away from asking whether the test is a fair metric and instead ask why the opportunity structure depends upon its results.

Fishkin christens these opportunity-limiting factors “bottlenecks” and pushes us to understand traditional antidiscrimination protections through that lens.  Thus, well-known protected statuses, such as race and sex, can be understood as bottlenecks because certain opportunities have been construed to require whiteness or maleness.  But legally recognized antidiscrimination categories, such as race and sex, are not the only bottlenecks we have to contend with.  Employers also restrict opportunities based on other factors, such as college education, credit history, criminal convictions, or unemployment.  My own scholarship has dealt extensively with yet another employer bottleneck: health.

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To Define the Beginning of Human Life or Not, That Is the Question

Twice a month I meet with some of my students for a critical reading.  In our last January meeting, we decided to commemorate Roe by re-exploring Judith Jarvis Thomson’s  seminal article A Defense of Abortion. Thomson’s defense of induced abortion by exploring our moral duties in the unrealistic case one found oneself kidnapped and plugged in to a virtuous violinist who is sick and needs one’s kidneys for nine months in order to heal has been highly criticized. Nonetheless, every time I read it or discuss it, I find how enlightening her thought experiment still is, as it confronts us with our set of moral beliefs and its incongrueties with our policy stances. Moreover, it makes me always ponder about our lack of a well-thought and coherent abortion regulating scheme.  But that is a topic for a different post. Today, I would like to concentrate on a related matter that stemmed from my discussion of Thomson’s article with my students.

By the end of our conversation my students and I were inquiring whether it was possible to assert a defense of stem cell research/therapy even taking for granted the right of life of the embryos, as Thomson did in her paper. It seemed obvious for almost all of us that using embryos for those purposes would be considered a blatant deprivation of the embryo’s right to life and an impermissible use of another person’s body; and thus, could not be sustained under Thomson’s argument. So we decided to try to come up with a scenario similar to Thomson’s violinist that could aid us in exploring the moral adequacy of stem cell research/therapy.

An appropriate thought experiment eluded our not so brilliant minds. We did not want to come up with a fallacious and common place thought experiment such as the one of the burning building test  in which one is forced to decide who to rescue first: twenty 8-cell embryos kept in a freezer or a baby in peril. We were not looking to formulate an experiment tilted to one side like the burning building test, in which the “incomplete human character” of the embryo is made self-evident by the “inescapable instinct” to rescue the “actual” human being. However, the truth is that it is quite difficult to come up, in a couple of minutes, with a reasonable possible scenario in which all the circumstances of stem cell research/therapy are replicated in a way that could sensibly help us assess our moral agency.

First, we would need to come up with a scenario in which we have a “human being” in a permanent frozen state (e.g. a cryogenized virtuous violinist) in which the conditions necessary for a successful life require a willing human host that is either related to the cryogenized violinist or has the authorization of his guardian to serve as a host for nine months.  Second, we must come up with a particular circumstance (e.g. a military operation) that would force the guardian of the cryogenized violinist to choose between using the frozen body to help in the recovery of a sick non-cryogenized human being (e.g. a  young Science Nobel laureate) whose only real, feasible and cost efficient chance to a healthy life is using that frozen body at the expense of eliminating all possible chances of an uncertain future life for the cryogenized violinist or leaving the cryogenized violinist frozen for an indefinite period of time and allowing for the sick non-cryogenized Nobel laureate to die. Finally, we would need to come up with the circumstances that led the cryogenized violinist to be treated as a surplus human being and at the same time be treated as the raw materials for the creation of future equally virtuous violinists (e.g. the practice of cloning virtuous musicians).  Furthermore, the example would need to consider the possibility of making the cryogenized violinist for the sole purpose of healing the sick non-cryogenized laureate (e.g. the possibility of the world coming to an end if the Nobel laureate does not find a solution to the problem before he dies from her sickness).

The end result is a very absurd, unrealistic and perhaps too intricate thought experiment.  Yet, exploring the limits of such an experiment may be a possible way to coming up with a defense of stem cell research/therapy even when one grants the right of life of the embryos.  Nonetheless, I would like to pose that the absurdity and illusory nature of these thought experiments suggest that we should face the inevitable: we must delimit when human life begins if we truly would like to come up with a moral/ethical regulation of stem cell research/therapy. This inescapable moral question is more evident when we contrast our legal stances and nation’s practices on issues like torture, war, death penalty, abortion, euthanasia and justification and necessity defenses.  The system is manifestly incoherent.

I do believe that a sensible answer will only come when we legally embrace the fact that life – and by extension human life – exists in a continuum. Law should echo that reality. A coherent and ethical sound system can only arise after we legally recognize that there is a point in that continuum in which life becomes human and that there are different stages before that point in which life is a subject of certain rights but not the same rights a human life is a subject thereof. Laws should define that moment and those stages. There is no moral reason to avoid doing so. As there is no ethical rationale either to treat totipotent, pluripotent, multipotent, oligopotent, unipotent cells, fully developed human beings not capable of living on their own, and born human beings in the same way.  Furthermore, our history and legal system have always made distinctions on how we treat the right to life of human beings based on particular deontological assumptions.

Our inquiry into how to regulate stem cell research/therapy should not be made under the assumption that embryos are in fact human beings and subjects of the same rights. A valid answer to this recent human reality must be based on a rigorous analysis of moral questions such as: 1. When does a life become a human life?; 2. Which type of rights is a non-human life entitled to?; 3. Are there different stages of a non-human life?; 4. Are those stages deserving of a differentiated right treatment?; 5. What are our moral duties to a human life?; 6.  What are our moral duties to a non-human life and it corresponding stages?; and 7. Under which circumstances are we relieved from those duties to human and non-human lives? These questions should be guiding our legislative process regarding scientific inquiries and not biased assumptions as to what constitutes human life.

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Neurocriminology: The Monsters are in the Molecules

Is the brain indeed the prime suspect when it comes to horrific crimes? Does our molecular structure or DNA determine our destiny, for the benevolent best or the malovent worst?

Such questions and others are explored in Dr. Adrian Raine’s book titled The Anatomy of Violence: The Biological Roots of Crime (Pantheon, 2013). This mind-opening book by a University of Pennsylvania professor of psychiatry and chairman of the department of criminology is the focus of an online symposium just posted on the Washington Independent Review of Books Gb4yObYARcACwebsite.

To help flesh out some of the instructive and provocative points raised in Dr. Raine’s illuminating book, NYU professor of Clinical Psychiatry Laurence R. Tancredi (who holds MD and JD degrees) and a University of Minnesota law professor Francis Shen (who specializes in neuroscience and the law) wrote commentaries. In the spirit of a free exchange of ideas, Dr. Raine authored a reply. I wrote the foreword to the symposium.