Category: Health Law

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Symposium on Carol Sanger’s “About Abortion”: Introduction & Commentaries

What follows is an online symposium concerning Professor Carol Sanger’s latest book, About Abortion: Terminating Pregnancy in Twenty-First-Century America (Harvard University Press 2017) (table of contents here). Links to the Introduction and Commentaries are set out below.

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Professor Carol Sanger

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Introduction to About Abortion Symposium

We are delighted to introduce Professor Carol Sanger and the participants in our online symposium on About Abortion: Terminating Pregnancy in Twenty-First-Century America (Harvard University Press 2017).

Professor Sanger, in her inimitable style, updates us on the state of the abortion debate in the age of Trump.  She explains how the experiences of women who have abortions have disappeared into the shadows while those who would outlaw it control the public discourse.  She explores the explosion of hostile legislation in state legislatures, as the new laws “treat abortion not as an acceptable medical decision—let alone a right—but as something disreputable, immoral, and chosen by mistake.”  Sanger’s book captures the reasons why the discourse has changed, and how abortion, which has always been a contentious issue, drives its emotional force from its connection to underlying debates about sex, religion, gender, politics, and identity.  She nonetheless seeks to reclaim women’s perspectives on the practice of abortion.   She argues that as women become more willing to talk about their experiences, “women’s decisions about whether or not to become mothers will be treated more like those of other adults making significant personal choices.”  In short, she seeks to normalize the topic of abortion.

The book covers original material that Sanger has assembled documenting the legal infrastructure for abortion decision-making.  She presents the experiences of vulnerable teens, forced to appear before hostile judges in an effort to secure permission to proceed without parental consent.  Courts deem many of the teens too immature to make such decisions on their own, but not apparently too immature to become mothers against their will.  She also describes the women required to undergo involuntary ultrasounds, the debate about whether the women are allowed to look away, and the insidiousness of this alleged effort to “help” women make the abortion decision.

Throughout, Sanger connects these practices to law, medicine, the organization of intimate relationships, the shape of a woman’s life, and national identity.  She takes pains to present  the objections to abortion accurately even as she also counters the depiction of decisions to end pregnancies as “selfish” or casual decisions to put women’s interests ahead of their children.  She distinguishes between abortion privacy, a form of nondisclosure based on a woman’s desire to control personal information, and abortion secrecy, a woman’s defense against the many harms of disclosure.   She captures women’s varied views, whether they treat abortion as unthinkable or as a measure necessary to allow them to become “good” mothers in circumstances of their choosing.

Indeed, Sanger’s original treatment of abortion includes a chapter on the views of men.  She asks not what decisions men would make about abortion; instead, she explores how they in fact decide whether to become fathers when they are faced with the choice of what to do with their frozen embryos.  The men in such circumstances express concern over the potential child’s future welfare, distress over an ongoing relationship with the other parent, an unwillingness to consider adoption as an acceptable alternative; in short, they express the same concerns that women do about whether to proceed with a pregnancy.  Yet, the right to life forces, while they often champion the rights of frozen embryos,  do not subject the men’s decisions  to the same intrusion and vilification they reserve for women.  Sanger speculates that if the same law that governs decisions about frozen embryos applied to women’s reproductive decisions, it “would not look quite the same as it does now, with assumptions of incompetence, layers of second-guessing, and invasive counseling.”

About Abortion adds to our understanding of the abortion debate.  It confronts the dishonesty and distortions that characterizes much of the public debate.  It acknowledges the way the issue is deeply intertwined with fundamental questions about the organization of society.  It advocates bringing the experiences of those who have chosen abortion out the shadows, and it succeeds in providing a richer foundation for public consideration of the issue.

About Abortion is an important book that has already received wide attention, including a New Yorker review that coincides with our consideration of it here.  http://www.newyorker.com/magazine/2017/04/03/why-its-become-so-hard-to-get-an-abortion.

For this Concurring Opinions book symposium, we have invited an all-star cast of thinkers who have a variety  of different perspectives on abortion:  Helen Alvare, Caitlin  Borgmann, Khiara Bridges, David Cohen, Leslie Griffin, Linda McClain, David Pozen, Lisa Pruitt, and Rachel Rebouche.

University of Utah Conference on Precision Medicine

Via Leslie Francis, news of a great conference at the University of Utah on precision medicine on Dec. 1 and 2. It will be livestreamed:

The federal Precision Medicine Initiative (PMI) announced in 2015 will be the largest study of human genetics and health in history. With a planned cohort of one million Americans, the PMI promises to increase our understanding of the genetic basis of disease and forge the way for new diagnostic and therapeutic innovations. The PMI is linked to another ambitious national initiative, Vice President Joe Biden’s “Cancer Moonshot,” which hopes to accelerate the cure for cancer using big data and precision oncology techniques. Though the technology to undertake these monumental projects exists today, many scientific, legal, economic, and ethical questions remain. This one and a half day symposium at the University of Utah will host leading national experts in medicine, bioinformatics, law, policy and ethics who are tackling the major questions raised by precision medicine, the PMI, and the Cancer Moonshot.

I wish I could watch, but I will be speaking at another conference. Best wishes to the Utah group!

Rebuilding Health Care Policy from the Ground Up

whatourdemocraticparty

Campaign Flier from the Wright Patman Archives (via Matthew Stoller)

The signature progressive initiative of early 21st century America–the Affordable Care Act–is about to be gutted.  In 2009, I agonized about whether to support it. In the last paragraph of a bloated blog post, I concluded:

By passing this reform bill, Democrats will jettison whatever “populist” credentials they once had, opting instead for an early-twentieth-century “progressive” vision of technocratic alliance between corporate and government experts. . . . We’ll commence an endless argument (read: notice and comment rulemaking and subsequent administrative adjudications) over what constitutes an adequate baseline of coverage. . . . But the fundamental victory of reform–the national commitment that no one should have to choose between death or bankruptcy when confronted with a serious illness–will also endure. The tragic paradox is that the Democrats can only achieve this great cultural and ideological victory by becoming identified with the very interests that only they are willing to confront.

I was right about a few things: it was a Pyrrhic victory, the backlash was brutal, and virtually every indignity or imposition concocted by private insurers in the past seven years has been blamed on “Obamacare.” But I was wrong about the most important points. The rulemaking and adjudications will end. The Trump/Ryan/McConnell approach to health care will leave Obamacare in the dustbin of history. And when it does, it will impose on millions of Americans exactly the situation they faced pre-ACA: choose between death or bankruptcy when confronted with a serious illness.

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In October, Larissa MacFarquhar published a thoughtful essay on “The Heart of Trump Country.” One supporter of the President-elect said:  “When you hear about illegal aliens getting benefits and you have people here starving to death and can’t get nothing, it’s just a slap in the face. When you start talking about bringing in refugees and when they get here they get medical and dental and they get set up with some funds—what do we get?” Here’s Obamacare’s answer:

Under the terms of the ACA, if you are unemployed, or if your employer’s insurance is unaffordable (defined as an individual plan (not a family plan) costing you over 9.5% of income), you can buy insurance on the exchange. You can choose plans from one of four precious metal tiers (bronze, silver, gold, and platinum), with varying actuarial values (60 to 90%). You’ll pay premiums, but you’ll also get sliding scale subsidies based on how high your income is above the poverty level. You will probably also need to pay co-pays, coinsurance (a percentage of each bill), and deductibles, up to some percentage of your income specified by statutory out-of-pocket maximums. (Just be sure not to incur out-out-network costs that don’t count toward out-of-pocket maximums.)

But you can get cost-sharing subsidies to cover some of that expense, based on a sliding scale slightly different than the premium assistance tax credit scale. Just be sure to shop carefully on the exchange, because some plans have narrow networks–that is, they may not cover the physicians or hospitals you normally use. In fact, you may have to drive 20 or 50 miles to find a physician in the network–the rules on network adequacy can be hazy. Note also that, in a narrow network, if you have a surgery, it’s possible out-of-network physicians or other personnel may attend, and you could be on the hook for the whole amount they charge–unless your state has a “no surprise billing” law.

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The Phantom Industrial Policy of the Beltway’s Favorite Health Cost Cutters

A few weeks ago, I spoke on artificial intelligence in health care at the AI Now Conference. I focused on the distinction between substitutive automation (which replaces human labor with software or robots) and complementary automation (which deploys technology to assist, accelerate, or improve humans’ work). I developed three cases where complementary automation ought to be preferred: where it produces better outcomes; in sensitive areas like targeting persons for mental health interventions; and to improve data gathering. Law and policy (ranging from licensure rules to reimbursement regs) could help assure that the health care sector pursued complementary automation where appropriate, rather than chasing the well-hyped narrative of robot doctors and nurses.

The pushback was predictable. Even if complementary automation is better now, shouldn’t our policy reward firms that try to eliminate ever more labor costs? Doesn’t *everyone* agree that the US spends too much on health care–and isn’t technology the best way of reducing that spending? Let me try to address each of these views, boiling down some perspectives from a longer, academic article.

A Policy at War with Itself

There is a troubling tension at the heart of US labor policy on health care and automation. Numerous high-level officials express grave concerns about the “rise of the robots,” since software is taking over more jobs once done by humans. They also tend to lament growth in health care jobs as a problem. In an economy where automation is pervasive, one would think they would be thankful for new positions at hospitals, nursing homes, and EHR vendors. But they remain conflicted, anxious about maintaining some arbitrary cap on health spending.

Politico reporter Dan Diamond encapsulated this conflict in his recent article, “Obamacare: The Secret Jobs Program”–and he leaves no uncertainty about which side he thinks is right:
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Platform Responsibility

Internet platforms are starting to recognize the moral duties they owe their users. Consider, for example, this story about Baidu, China’s leading search engine:

Wei Zexi’s parents borrowed money and sought an experimental treatment at a military hospital in Beijing they found using Baidu search. The treatment failed, and Wei died less than two months later. As the story spread, scathing attacks on the company multiplied, first across Chinese social networks and then in traditional media.

After an investigation, Chinese officials told Baidu to change the way it displays search results, saying they are not clearly labeled, lack objectivity and heavily favor advertisers. Baidu said it would implement the changes recommended by regulators, and change its algorithm to rank results based on credibility. In addition, the company has set aside 1 billion yuan ($153 million) to compensate victims of fraudulent marketing information.

I wish I could include this story in the Chinese translation of The Black Box Society. On a similar note, Google this week announced it would no longer run ads from payday lenders. Now it’s time for Facebook to step up to the plate, and institute new procedures to ensure more transparency and accountability.

The State of Legal Scholarship: A View from Health Law

Based on Ron Collins’ post below, I read the interview with Judge Edwards. The judge states:

In order for legal scholarship to be relevant outside the legal academy, law professors should balance abstract scholarship with scholarly works that are of interest and use to lawyers, legislators, judges, and regulators who serve society through legal arguments, decision-making, regulatory initiatives, and enforcement actions.

Fortunately, every legal academic that Nicolas Terry and I have hosted in our 41 episodes of The Week in Health Law has done so. Perhaps that’s a biased sample. But it’s undoubtedly better than the sampling practiced by Justice Breyer, another critic of legal scholarship.

For now, I will take some comfort that, about a year into our podcasting, we have heard from general counsels, attorneys, regulators, and journalists who are big fans of the show–which primarily focuses on the work of legal academics. And I will remain dubious of generalized critiques of legal scholarship, which fail to analyze the merits of particular fields.

Greene & Kesselheim vs. Kardashian

Jeremy Greene and Aaron Kesselheim have a fascinating piece on the new challenges facing the FDA as selfie-driven marketing reaches Instagram. After promoting an anti-nausea drug (for morning sickness, not in anticipation of celebrity-phobic viewers), Kardashian had to follow up with the following “corrective advertisement:”

#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis.

As Greene and Kesselheim observe:

The rise of social media has raised a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role. Before Instagram, television advertising was once new; before television, radio. Since the agency’s founding, its ability to regulate drugs has been consistently challenged by new forms of communication.

For more on the controversy, check out The Week in Health Law, where Nicolas Terry and I discuss the case with Kesselheim. And don’t worry, it’s not all about Kardashians–we also cover a new study of ACOs, proposed budget cuts for AHRQ, worry over unintended consequences of readmission penalties, and EHR gag clauses (and developer codes of conduct).

The Week in Health Law, Back to School Edition

If you want to learn about a fast-changing field, check out health law. It’s hard to keep track of all the recent developments in subfields of it (bioethics, insurance regulation, malpractice, EHRs and privacy, among others), let alone the field as a whole. Fortunately, there are many scholars and practitioners who are diligently working on all these issues. Nic Terry interviewed many of them for our “Back to School” podcast on health law.

Here are the contributors, with links to articles on the issues they discussed:
Micah Berman – PBS Unnatural Causes
Erin Fuse Brown – Physician Self-Referral Updates (STARK)
Glenn Cohen – Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark – Pickup v. Brown
Nicole Huberfeld – Armstrong v Exceptional Child Center Inc. 
Elizabeth Weeks Leonard – King v. Burwell
Frank Pasquale – Narrow Networks
Ross Silverman – Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr.–  Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry – North Carolina State Board of Dental Examiners v. Federal Trade Commission

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter: @nicolasterry and @HealthPI (for my health tweets) or @FrankPasquale (for law & tech, surveillance, algorithms & political economy). @WeekInHealthLaw is the show feed.

 

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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