Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariMichael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from physicians’ views of the Sunshine Act; to a biomarker-based drug development case study of CETP inhibitors, to the potential return on public investment in detecting adverse drug effects. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chimonas S, DeVito NJ, Rothman DJ. Bringing Transparency to Medicine: Exploring Physicians’ Views and Experiences of the Sunshine Act. Am J Bioeth. 2017;17(6):4-18.
  2. Dong K, Boehm G, Zheng Q. Economic Impacts of the Generic Drug User Fee Act Fee Structure. Value Health. 2017;20(6):792-8.
  3. Hey SP, Franklin JM, Avorn J, Kesselheim AS. Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors. Circ Cardiovasc Qual Outcomes. 2017;10(6).
  4. Huybrechts KF, Kesai RJ, Park M, Gagne JJ, Najafzadeh M, Avorn J. The Potential Return on Public Investment in Detecting Adverse Drug Effects. Med Care. 2017;55(6):545-51.
  5. Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-Year Impacts Of The Affordable Care Act: Improved Medical Care And Health Among Low-Income Adults. Health Aff (Millwood). 2017;36(6):1119-28.
  6. ‘t Hoen EFM, Boulet P, Baker BK. Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. J Pharm Policy Pract. 2017;10:19.

Breaking the Mold: Law and Mold Remediation after a Natural Disaster

By Nicolas Wilhelm, JD

We’re in the midst of the hurricane season here on the East Coast, and with hurricanes come a host of health-related concerns from emergency preparedness to the clean-up after a disaster.

One of the issues rarely discussed in the aftermath of hurricanes Katrina and Sandy —two of the costliest natural disasters in US history — is the mold growth that occurred in water-damaged homes. One study indicated that the concentration of mold in flooded areas after Hurricane Katrina was roughly double the concentration in non-flooded areas.

With natural disasters occurring with greater frequency in recent years (there were three times as many natural disasters occurring from 2000 through 2009 than from 1980 to 1989), law may play a role in keeping Americans safe.

Continue reading

Sharing Data for 21st Century Cures – Two Steps Forward…

By Mary A. Majumder, Christi J. Guerrini, Juli M. Bollinger, Robert Cook-Deegan, and Amy L. McGuire

The 21st Century Cures Act was passed with support from both sides of the aisle (imagine that!) and signed into law by then-President Obama late last year. This ambitious legislation drives action in areas as diverse as drug and device regulation and response to the opioid epidemic. It also tackles the issue of how to make data more broadly available for research use and clinical purposes. In our recently published GIM article, “Sharing data under the 21st Century Cures Act,” we examine the Act’s potential to facilitate data-sharing, in line with a recent position statement of the American College of Medical Genetics and Genomics. We highlight a number of provisions of the Act that either explicitly advance data-sharing or promote policy developments that have the potential to advance it. For example, Section 2014 of the Act authorizes the Director of National Institutes of Health to require award recipients to share data, and Section 4006 requires the Secretary of Health and Human Services to promote policies ensuring that patients have access to their electronic health information and are supported in sharing this information with others.

Just as relevant, the Act takes steps to reduce some major barriers to data sharing. An important feature of the Act, which has not been extensively publicized, is its incorporation of provisions from legislation originally proposed by Senators Elizabeth Warren and Mike Enzi to protect the identifiable, sensitive information of research subjects. Senator Warren, in particular, has been a vocal advocate of data sharing. Arguably, one of the biggest barriers to sharing is public concern about privacy. The relevant provisions address this concern chiefly via Certificates of Confidentiality. Among other things, the Act makes issuance of Certificates automatic for federally-funded research in which identifiable, sensitive information is collected and prohibits disclosure of identifiable, sensitive information by covered researchers, with only a few exceptions such as disclosure for purposes of other research. These protections became effective June 11, 2017. While NIH has signaled its awareness of the Act, it has not yet updated its Certificates of Confidentiality webpage. Continue reading

How to Destabilize Insurance Markets Without Really Trying

Cross-posted from the Take Care blog

On Thursday, Senate Majority Leader Mitch McConnell released the latest draft of his effort to repeal the Affordable Care Act (ACA). As of last night, it appears that this version of the bill is dead, with four Senators declaring that they won’t vote to move it forward. But provisions of this bill are worth talking about, both for what they reveal about health insurance and for what they reveal about the process by which the Senate is considering ACA repeal.  The latest draft contains a number of new provisions, but two caught my eye: (1) Senator Ted Cruz’s attempt to bifurcate the individual insurance market and (2) a clause about membership in a health care sharing ministry as satisfying the requirement of “continuous creditable coverage.”

The Cruz amendment has received a large amount of coverage both in the popular press and by more specialized policy outlets. But there has been little attention to the clause about health care sharing ministries. Fortunately, I wrote a 5,000 word book chapter on the ministries as part of an academic conference in 2015 (here I am presenting on the topic, if you’re really interested). Continue reading

An All Lightning Round ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Frank and Nic internalize their travel issues and try to get to grips with some of the recent stories from healthcare land. Among the stories we discuss are the UK Information Commissioner’s report on the Royal Free – Google DeepMind trial, US-EU competition policy (another Google case), a class action in Alaska involving a DTC genetic service that is butting heads with a very strongly worded state statute, the opioid crisis seen through a litigation lens, and our latest thoughts, rants, and questions about health reform/repeal including the latest on the three-legged stool and cost-sharing subsidies.

As for Google DeepMind, we start with a discussion of how Google DeepMind trial failed to comply with data protection law. We discuss Google’s larger problems with the EU Competition and Franks’s response to US skepticism about the case. Continue reading

Copenhagen Conference: Legal Perspectives on Synthetic Biology and Gene Editing

Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing.

CALL FOR PAPERS

Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by humanity, such as climate change, environmental protection, growing population, renewable energy and improved health care. But the emerging applications also raise exceptional ethical, legal and social questions.

This conference marks the final phase of the participation of the Copenhagen Biotech and Pharma Forum (CBPF) Research Group at the Centre for Information and Innovation Law (CIIR) in the cross-faculty research project BioSYNergy. In accordance with the goals of this large cross-faculty project on Synthetic Biology, the event explores legal perspectives on synthetic biology, systems biology and gene editing. Dealing with the legal responses to ethical and scientific challenges raised by emerging life science technology. Continue reading

EPSDT: The little known acronym that helped millions of children

By Emma Sandoe

This year marks the fiftieth anniversary of the passage of the legislation that created the Early Periodic Screening, Diagnostic, and Treatment (EPSDT) program. The program requires states to provide screening and treatment to Medicaid eligible low-income children under the age of 21. In 2014 an estimated 40 million American children, or nearly one in every two kids, were eligible for this program. The Republican Obamacare repeal bills, the American Health Care Act (AHCA) and Better Care Reconciliation Act (BCRA) gives states the option to end this program for certain kids. EPSDT has improved the lives of millions of children and families in the Medicaid program over the last 50 years and has incidentally improved care for many millions more Americans.

As part of the first bill that made changes to Medicaid, this policy would become one of the most significant developments in the history the public health insurance program. Medicare and Medicaid were passed and signed into law in July of 1965 under the Medicare Act of 1965. A year later, the Medicaid program began to be implemented in states that took up the option. By the end of 1967, 38 states had opened their Medicaid programs to enrollment and begun providing services to low-income single-parent families and elderly and disabled individuals. Despite these coverage gains and medical treatment, many low and moderate-income children in two parent households lacked access to medical care. EPSDT was the first of many significant Medicaid coverage expansions to children. What was unforeseen at the time was the way that the benefits of EPSDT have been felt across the health care system and broader population. Continue reading

How should we organize consent to research biobanking in the hospital?

By Alena Buyx, MD PhD

Ever wondered what happens to the biological material you leave behind when you check out of the hospital? Nothing much, is the usual answer. However, the little bits of blood, tissue, and urine are potentially valuable for medical research; miniscule amounts of it may already allow sophisticated analyses, including genetic ones. Thus, in an approach termed ‘healthcare-embedded biobanking’, healthcare providers have started collections of leftover patient materials to create resources for future research.

However, unlike traditional research, healthcare-embedded biobanking is not done with a clear research question in mind. The materials are simply left-overs from diagnosis or treatment and, at the time of collection, the scientific projects for which they may be used eventually are entirely unclear.

This approach leads to an ethical conundrum. Established research ethics frameworks found here and here require that patients be asked for their consent and that they are given  all the information they need to make an informed decision about whether to donate their material (and its associated data) or not.  This includes, in particular, the research goals as well as the potential benefits and risks. However, this provision of information is not possible in healthcare-embedded biobanking: the risks and benefits can only be described in very broad terms, and the goals and timing of future research are usually unknown. Indeed, the materials may even not be used at all. Continue reading

The Problematic Patchwork of State Medical Marijuana Laws – New Research

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

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Housing Equity Week in Review

We’re back after a few weeks’ hiatus because of summer holidays. There was much ado this week about the Low Income Housing Tax Credit (LIHTC), spurred by an article in the NY Times (third bullet down). Some of the conversation circling that article are captured in the subsequent bullets.

Here are the latest news stories in housing law and equity for the week of July 2-10, 2017:

  • Given the local context of housing policy, it is hard to find “one glove fit all” solutions. There is a growing consensus that zoning and  land use regulations have made the affordability crisis in booming cities such as New York City and San Francisco worse. Could the policy that harmed one area saved another? Richard Florida of CityLab argues that land use regulation saved the Rust Belt.
  • Suburbia is still largely thought of as white and affluent, while inner cities are thought of as poor and black. A new book by Scott Allard of the University of Washington, called Places in Need, debunks misconceptions about suburban poverty. The author was interviewed by CityLab.
  • The United States spends $8 billion each year in tax credits to provide more affordable housing. A The New York Times article on the Low Income Housing Tax Credit (LIHTC) suggests the program entrenches segregation on the lines of class and race.
  • On the other hand, the Washington Post covers a Stanford study (originally published in NBER in April 2016) that shows that building LIHTC affordable housing developments into low income neighborhoods can increase property values and lead to income and racial integration.
  • Daniel Hemel, an assistant professor at University of Chicago school of Law, responds to the New York Times article, in his own post here.
  • In May 2016, Daniel Hertz of City Observatory responded to the Stanford study, pointing at methodological issues and challenging the study’s conclusion, here.

How the GOP Misread Public Anger over Obamacare

By David Orentlicher

In today’s New York Times, Kate Zernike reports on the lack of excitement among conservative activists for the Republican health care legislation. As Zernike observes, “President Trump and congressional leaders are getting little support from what were once the loudest anti-Obamacare voices.”

Some observers think that activists are disappointed in the failure of the GOP proposals to go far enough in repealing the Affordable Care Act. But that’s not the real story. In general, the public likes many of Obamacare’s key provisions, such as the protections for people with preexisting medical conditions or the ability of parents to insure their children up to age 26. Even among Republicans, there is majority support for the ban on higher premiums because of preexisting conditions and also for the mandate that insurers cover “essential health benefits.” And by 2014, Obamacare had faded as a campaign issue for Republican candidates for Congress.

So why don’t grassroots Republicans care so much about repealing the Affordable Care Act? Tea Party activists and other voters were genuinely mad about Obamacare, and they fueled the Republican wave in the 2010 House elections that saw Republicans gain 63 seats. But what made them angry was the feeling that President Obama cared more about health care than he did about the economy. In March 2010, when Obama signed the Affordable Care Act into law, the unemployment rate was 9.7 percent. The public cared much more about jobs than about health care insurance, and they saw their President focusing on health care. Remember how many times Obama promised to “pivot” back to the economy?

Voters elected President Trump and gave Republicans majorities in the House and Senate because they wanted more jobs at better pay. If the GOP lets health care distract it from economic stimulus, we may see another wave election in 2018.

How the FDA Produces Knowledge (and Is Not So Weird)

Credit: SalFalko

The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA.  In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech regulations are especially worrisome when motivated by paternalism.  This argument has received some traction in the courts, and is now getting a favorable look by the Trump administration.

I have argued (here, here, and here) that this law is not actually a speech regulation.  Nor is it paternalistic.  Instead, it is simply a vanilla regulation of a behavior (shipment of product in interstate commerce), which depends on various sources of evidence (including speech) as revealing whether the actor has an illicit intent (an unapproved use of the product).  The pre-market approval system, which requires that companies prove safety and efficacy for all intended uses, solves a collective action problem to produce information as a public good.  This is our key social mechanism for producing knowledge about safety and efficacy.  If this law is unconstitutional in the off-label context, the entire pre-market approval system would seem to be as well.

In a new piece out on SSRN, my physician co-author Victor Laurion develops the example of the drug Seroquel XR, to show how a federal prosecution for off-label promotion caused the company to perform scientific research on two new indications (general anxiety disorder and major depression).  A detailed discussion of the regulatory record shows how physician prescribing was improved by this public information, regardless of whether the FDA approved the new indication.  In this way, the FDA protects the liberty of physicians and patients to try drugs for new uses, even while holding companies to the proof of any uses that they actually intend.  The fact that the company’s intention is shown by speech evidence is immaterial. Continue reading

John A. Robertson (1943 – 2017)

Renowned bioethics scholar, longtime University of Texas Law Professor, and frequent Bill of Health contributor John A. Robertson has recently passed away. We at the Petrie-Flom Center mourn his passing, and our Faculty Director I. Glenn Cohen writes a few words:

I saw John roughly a month ago at the Baby Markets Roundtable at UT Austin. He was, as he always was and as he still seems to me in my mind’s eye, full of electric intellectual energy, warmth, and whimsy. Every comment that I heard him make for over a decade at conferences began: “That’s so interesting…” and then he would proceed to subtly add something to whomever he responded to that was at once flattering of the idea and also five times better than what was said by original speaker. Certainly that’s how it felt when I was the person to whom he was responding.

Much will be said in coming weeks about his work—not only the centrality of Children of Choice to almost everything that has been written since on reproductive technology, but also the breadth of his work and the way in which almost every new technology soon had a wonderful take by him in print (IVF and uterus transplants most recently).

I’ll limit myself to two reflections. First, the way in which he put the field I write in (law and bioethics or law and the biosciences, depending on who you ask) on to the law school map, and with a few others (Rebecca Dresser, Alta CharoHank Greely, etc), gave it legitimacy as a real and important area of focus within law schools.

Second, and more personally, John was just about the best mentor to young scholars I have ever encountered. I met him first while I was a fellow at an ASLME event and I was blown away by the warmth and generosity of someone I considered a giant in the field (my idol if I’m honest) to a little pischer like me. Over the years I saw him do the same for countless others and I tried to do my best to palely imitate.

I can’t believe he is gone. The world seems a little darker.

Leslie Francis and John Francis on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Two very special guests and the Pod’s first power couple interview. This week we talk with Leslie P. Francis and John G. Francis about their new book, Privacy: What Everyone Needs to Know. Leslie Francis is a professor of law and a professor of philosophy at the University of Utah, and John Francis is a research professor in the Political Science Department, also at the University of Utah.

Leslie is one of our leading privacy scholars and John is an expert in comparative politics and regulatory policy, ethics, and data policy. We explored privacy theory, how privacy differs between economic domains, and the relative benefits of consent, use, and delinking regulation.

As the Francises explain, “A great deal is at stake for individuals, groups, and societies if privacy is misunderstood, misdirected, or misused. Popular understanding of privacy doesn’t match the heat the concept generates. With a host of cultural differences as to how privacy is understood globally and in different religions, and with ceaseless technological advancements, it is an increasingly complex topic.”

We cover several areas of health privacy, and also zoom out and consider health data in the context of other recent controversies in data protection and management (such as the right to be forgotten). The Francises seamlessly weave together legal, philosophical, bioethical, and regulatory perspectives on privacy while providing direct yet nuanced answers to common questions about it. We hope TWIHL listeners will enjoy this conversation, and check out the book!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. 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 @FrankPasquale @WeekInHealthLaw

Book Review: Phyllis Shacter’s “Choosing to Die” (A Story of Death by Voluntarily Stopping Eating and Drinking)

For some people, being mired in progressively degenerative dementia is an intolerably distasteful prospect.  Precipitous mental deterioration would, for them, indelibly soil the lifetime image to be left with survivors and would pose a repugnant physical and emotional burden upon caregivers.  They know that lingering in an utterly dysfunctional cognitive state can continue for many years.

One tactic to avoid prolonged dementia, after initial diagnosis, is to take steps to end one’s existence while still competent.  And one lawful method of self-arranged death is by voluntarily stopping eating and drinking (VSED).  Strict cessation of nutrition and hydration will typically precipitate death by dehydration within 10 to 14 days.  The patient will likely lapse into delirium or confusion after a number of days and remain semi-conscious or unconscious for the duration.

The VSED route is derided by some sources as a repulsive ordeal both for the patient and surrounding caregivers.  The detractors portray the process as both torturous and excessively undignified.  They envision death “by starvation” as entailing unavoidable suffering.  They perceive offensive indignity in the accompanying erosion of mental clarity (delirium) and in days of semi-conscious or unconscious lingering.  This liminal period is deemed demeaning to the patient and “a horrible vigil” for surrounding family watching the wasting patient die. Continue reading

More on the ECJ Vaccine Liability Decision

By Alex Stein

My friend and mentor, the former Israeli Chief Justice Aharon Barak, used to say that when neither side likes the court’s decision, chances are that the court was right. This is likely to be the case with the European Court of Justice (ECJ) decision on vaccine manufacturers’ liability, N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. Popular press reacted to this decision with sharp criticism that included unsubstantiated assertions about the European law of products liability, about what the Court did and did not say, and about the economics of vaccines. My short blog-post, which appeared here, offered a more positive (and hopefully more informative) assessment of this decision and its implications. I argued that the decision was balanced and well grounded in the principles of evidence and products liability. The follow-ups and subsequent analyses that appeared in Nature, Science and Hipertextual (in Spanish) have largely vindicated the decision (while citing some of its critics alongside the decision’s supporters such as myself).

To remove any remaining confusion about the implications of the ECJ decision, I thought I should clarify the Court’s statement that a vaccine liability suit can only succeed when the plaintiff proves that the vaccine complained against was “defective” within the meaning of Article 6(1) of the European Council Directive on products liability (85/374/EEC) (the Directive). Critics of the Court’s decision have uniformly missed this important proviso. Continue reading

Harvard Grad Students: Apply Now! Petrie-Flom Center Student Fellowship, 2017 – 2018

PFC_Logo_300x300The Center and Student Fellowship

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website and check out profiles of some of our past Fellows in the PFC Spotlight.

Eligibility

The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs to wait until after their first year to apply. Continue reading

Keeping an Eye on the Eleventh

By Zack Buck

A particularly noteworthy health care fraud case—one that could have a major impact on the falsity requirement of the Federal Civil False Claims Act (FCA)—awaits a decision from the Eleventh Circuit as we enter the second half of 2017.  U.S. v. AseraCare, a case that could determine whether “objective falsity” and not only a “difference of opinion” is required for FCA liability, had oral arguments in mid-March in front of the Eleventh Circuit, and has been called a “case to watch” in 2017.  A decision is still forthcoming.

AseraCare was particularly notable because the FCA claim—which was alleged against the corporate hospice provider for allegedly fraudulently certifying individuals for hospice eligibility among other alleged claims—was abruptly dismissed in the Northern District of Alabama in 2016.  Rejecting the claims because the government failed to prove that the claims at issue were objectively false, Federal District Court Judge Judge Karon Owen Bowdre found that the government only proved that a clinical disagreement existed as to whether or not the patients should have been certified as hospice-eligible, which was insufficient to prove a false claim under the FCA.  According to the court, allowing the government to prove that a FCA action could be maintained based only upon the government’s disagreement with the defendant’s clinical judgment would allow the government to “short-circuit” the FCA’s falsity requirement. Continue reading

Michele Goodwin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week, University of California, Irvine Law Professor Michele Bratcher Goodwin offers a detailed and insightful analysis of an increasingly adversarial relationship between women and the state. In a series of articles, Goodwin has demonstrated that pregnancy is being policed by an array of oppressive state laws, many of which are being used in contexts far removed from their legislative intent. She asks in “The Pregnancy Penalty,” “If a woman is fourteen times more likely to die during pregnancy and childbirth than terminating a pregnancy through a legal abortion, why do some lawmakers resist support for contraception and seek to criminalize abortions?” Today’s podcast includes many troubling answers, rooted in historical and social theoretical analysis.Our conversation includes a detailed look at leading abortion cases and their limitations. We end with a disturbing narrative about under-age marriages in the US, often in circumstances that otherwise would be statutory rape. Goodwin describes the failed institutions that have made underage marriage a global problem.

Michele Goodwin is a Chancellor’s Professor at the University of California, Irvine with appointments at the School of Law; Program in Public Health; Department of Criminology, Law, & Society; Department of Gender and Sexuality Studies; and Stem Cell Research Center. Her publications include six books and over 80 articles and book chapters on law’s regulation of the human body, including civil and criminal regulation of pregnancy and reproduction, reproductive technologies, human trafficking (for organs, sex, and marriage), and tissue and organ transplantation.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. 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 @FrankPasquale @WeekInHealthLaw

FDA v. Opana ER: Opioids, Public Health, and the Regulation of Second-Order Effects

Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market.  Opana ER is an extended-release pain reliever often abused by those who take it.  While opioid abuse is nothing new, and many opioids leave those who take them addicted to narcotics or heroin, Opana ER is particularly dangerous because of how people misuse it.  The pill was designed to prevent would-be abusers from crushing and snorting it —  a popular means of ingesting prescription opioids.  Without the ability to crush and snort the drug, however, abusers turned to dissolving the pills and injecting them intravenously, leading to outbreaks of Hepatitis C, HIV, and other blood-borne diseases.  In Indiana’s Scott County, for instance, the prevalence of HIV has skyrocketed since the introduction of Opana ER to the local population, with 190 new cases since 2015.

While this foray into public health is somewhat surprising — given the anti-regulatory stance of the current administration and its billionaire backers — it is precisely the type of initiative the FDA should be taking.  Public health is a central part of the FDA’s mission statement, which notes that the agency “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”  Traditionally, though, the FDA’s efforts to ensure safety and efficacy have been limited to the narrow context of individual patients taking medications as directed under physician supervision.  As the FDA noted in its Opana ER press release, this is the first time it has requested that an opioid be taken off the market as a result of its susceptibility to abuse and the associated public health consequences.

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