close up of an open book

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 December. The selections feature topics ranging from potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website. Read More

Pile of colorful pills in blister packs

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the upcoming Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In the final post of the Promises and Perils of Emerging Health Innovations blog symposium, Leo Beletsky and the team from Health in Justice Action Lab provide a summary of an event held in conjunction with the Center for Health Policy and Law’s 2019 annual health law conference. The Promises and Perils of Prescription Drug Monitoring Programs (PDMPs) workshop was held on April 13, 2019 and convened experts, practitioners, experts, and other stakeholders to brainstorm strategies with the goal to “maximize the benefits of PDMPs, while minimizing harms.” Visit the Health in Justice Action Lab website (linked below) for information on this and other projects underway. 

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

By Health in Justice Action Lab

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Close up of the Lady of Justice statue

The Privatization of Opioid Litigation

By Dan Aaron

As the opioid litigation continues over the shadow of one of our nation’s most pressing public health crises, some criticism has been levied at private lawyers representing the cities, counties, states, and individuals harmed by the crisis. For example, see the following tweet:

Let’s work out tax and healthcare financing policy county by county, with private lawyers taking a 25% cut every time. Judge Polster seems to like this idea.

The critiques are many, but can be summarized: (1) private lawyers are being enriched; (2) private lawyers are setting opioid policy; (3) private lawyers have misaligned incentives; and (4) private lawyers will not support public health.

Arguably, all these arguments bear some truth. However, do they suggest that the opioid litigation is incorrigibly tainted and tort litigation the improper avenue to address mass torts such as the opioid crisis?

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Stack of colorful books in front of a wood paneled wall

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 September. The selections feature topics ranging from the contributions of academia and industry to lung cancer survival gains, to the savings from the EpiPen authorized generic, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

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Pregnant woman sitting across desk from doctor wearing scrubs and holding a pen

Opioid Claims for Fetal Opioid Exposure Alarm Pregnancy Advocates

By Alexa Richardson

Lawyers calling themselves the “Opioid Justice Team” are pushing forward in their mission to certify babies exposed to opioids in utero, as well as “all women in the United States capable of becoming pregnant,” as distinct classes in the multi-district opioid litigation now unfolding in federal court in Ohio. Last week, lawyers filed an amended complaint on behalf of the legal guardians of individuals diagnosed with neonatal abstinence syndrome (NAS), and a list of “experts” with the court. Their claims misrepresent the science regarding fetal exposure to opioids and position fetal rights in opposition to those of pregnant people. National Advocates for Pregnant Women (NAPW) has issued a statement and fact sheet denouncing the claims.

In a series of court filings, sweeping claims about the impact of prescription opioid exposure on fetuses are being made. The lawyers falsely claim “[a]nything a pregnant woman ingests or breathes is transmitted to her baby by the placenta” and that “[i]n-utero opioid exposure leaves most children with physical, social, educational disabilities that require constant and regular interventions. Most of these disabilities are considered permanent.” In actuality, the American College of Obstetricians and Gynecologists states that the available data show “no significant differences” in long-term outcomes for individuals exposed to opioids in utero versus those who are not. The Centers for Disease Control (CDC) finds there may be early childhood impacts on cognitive or developmental abilities from prenatal opioid exposure. However, available studies struggle to separate the physical effects from environmental and social variables. There is not enough data to conclude whether any long-term consequences of fetal opioid exposure exist, the CDC finds.

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Ohio state flags waving in front of the Ohio State House

Ohio’s Efforts to Centralize Control Over Opioid Claims

By Daniel Aaron

On October 21, two Ohio counties are slated to present their opioid claims in a federal trial. However, last week, 13 states and the District of Columbia signed onto a brief requesting that the 6th Circuit Court of Appeals stay the upcoming trials. Their reasoning? States should control lawsuits for harms within the state; cities and counties do not have authority to sue on their own. While it makes sense that Ohio’s attorney general, spearheading this effort, would want more power and control over opioid claims, the move has the potential to harm public health by disempowering local governments from addressing public health crises. Ohio’s three main arguments will be discussed in turn.

Argument 1: Violation of State Sovereignty

First, Ohio argues that the county lawsuits violate state sovereignty and disrupt the “federal dual-sovereign structure” of the United States:

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Black and white photograph of a gavel in front of scales of justice

Big Ruling in Philadelphia: The Controlled Substances Act does not forbid a safe drug consumption room

By Scott Burris

Federal District Judge Gerald McHugh of the Eastern District of Pennsylvania ruled today that the operation of a safe injection site to prevent overdose, HIV, and other harms associated with drug injection would not violate the federal Controlled Substances Act.  The ruling came in an action for declaratory and injunctive relief brought by the local U.S. Attorney, seeking to prevent the opening of “Safehouse” by a private group led by former Pennsylvania Governor and Philadelphia Mayor Edward G. Rendell. The judge denied the requested relief.

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Photograph of Purdue Pharma headquarters

The Role of Attorneys General in the Opioid Litigation

By Daniel Aaron

People following the opioid lawsuits might have noticed some strange headlines as of late. Virtually every state’s attorney general (AG) is suing Purdue Pharmaceuticals, maker of the blockbuster drug OxyContin. Purdue filed for bankruptcy and is hoping to settle for “$10 billion.” However, the deal only includes $4.4 billion in cash, which is less than the Sackler family, owners of Purdue, transferred to personal accounts over the past decade. In other words, the amount of money the Sacklers made from the opioid epidemic is more than what they will pay more than forty states to help abate the crisis. Is anyone supporting this deal?

Yes, in fact, and this is where the plot thickens. With several exceptions, support for the deal falls along party lines: Republican AGs support the deal, and Democratic AGs oppose it. Why does a decision about settling with an opioid company appear to be political? What is the role of an attorney general? And are they supposed to defend public health?

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Photograph of a gavel and three open books

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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.

Read More