BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

The NIH Has the Opportunity to Address Research Funding Disparities

By Leah Pierson

The Biden administration plans to greatly increase funding for the National Institutes of Health (NIH) in 2022, presenting the agency with new opportunities to better align research funding with public health needs.

The NIH has long been criticized for disproportionately devoting its research dollars to the study of conditions that affect a small and advantaged portion of the global population.

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Brown Gavel With Medical Stethoscope Near Book At Wooden Desk In Courtroom.

Most-Cited Health Law Scholars in Westlaw, 2016-2020

By Mark A. Hall and I. Glenn Cohen

A few years ago, to highlight the growth and maturity of the health law field we undertook to measure and rank the scholarly impact of health law professors according to the frequency their work is cited. Our principal ranking followed the methods Gregory Sisk and Brian Leiter have used for many years to rank professors in other fields of law.

Leiter has now included Health Law in the pantheon of ranked legal fields. Accordingly, we will not undertake an independent ranking. Instead, because the data Sisk and Leiter use are restricted to professors with a primary law school appointment, we provide the following modest supplement: We replicate Sisk and Leiter’s citation counting methods for two health law professors known to be highly cited who do not have a primary law school appointment: Aaron Kesselheim and Sara Rosenbaum. (We did the same for several others, but their citation counts in the Westlaw database were below Leiter’s cutoff range). Here is the augmented ranking:

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Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

By Govind PersadPatricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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Finger pressing Apple Maps button on the Apple CarPlay main screen in modern car dashboard.

Addressing Distracted Driving: The Problem is Bigger than Texting

By Jack Becker

Distracted driving is deadly.

In 2019, 8.7% of all motor vehicle traffic fatalities involved a distracted driver, totaling 3,142 fatalities. And hundreds of thousands more are injured due to distracted drivers each year.

So, what are the solutions? Anti-drunk driving initiatives may provide some valuable insights.

The share of motor vehicle fatalities involving alcohol impairment has declined from 41% in 1985 to 28% in 2019.

Much of this decrease is attributable to laws and law enforcement. When the FY 2001 Transportation Appropriations bill included a provision setting the national impaired driving standard at .08 BAC, it was touted as saving an estimated 500 lives per year. Every state has some form of drunk driving law, and 38 states have open container laws, and these laws seem to impact fatalities.

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books

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

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva Wang, 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.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from an overview on the evolution of medical device regulation in the United States, to an analysis of the impact of the disclosure of expanded access policies mandated by the 21st Century Cures Act, to an evaluation of how litigation has impacted the success of the Biologics Price Competition and Innovation Act.

A full posting of abstracts/summaries of these articles may be found on our website.

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Symbol of law and justice, banknote of one dollar and United States Flag.

Saving Lives and Decreasing Costs: The Economic Case for Health Justice

By Wendy Netter Epstein

Most proponents of health justice will tell you that health is a fundamental human right. They will say that there is a moral imperative to eliminate health inequities and to give all people equal opportunity to lead a healthy life. And they will be correct. Health justice as a framework is driven by this narrative — the laudable goals of health equity and social justice.

What you aren’t as likely to hear from health justice advocates, however, is that health justice is economically efficient. To the contrary, most health justice advocates see its framework as an alternative to the markets, efficiency, autonomy, and individual responsibility that are the hallmarks of conservative ideology.

Yet, there is no question that health inequities are costly to the individuals that bear them, in higher health care expenses, missed days of work, and fewer years lived. There are also significant costs to society — both direct and indirect. According to one analysis, disparities lead to $93 billion in excess medical care costs and $42 billion in lost productivity per year.

Making the economic case for health justice, and noting how it is inextricably linked to the moral case, is crucial. Because not only is the framework bolstered by notions of both fairness and efficiency, but also, as a practical matter, getting legislative and regulatory buy-in to fund initiatives to address health inequities requires making the economic case.

If health inequities could be ameliorated, government health spending and other safety net spending would be drastically reduced, workforce productivity would increase, and even healthy and wealthy Americans — who are the most likely to oppose the health justice framework — would benefit.

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Pile of colorful pills in blister packs

The Age of Orphans

Join the author today for the 2021 CeBIL Symposium. Register here!

By Sarah Rickwood

The 2020s are the age of orphan medicines.

Orphan medicines are available for a larger number of diseases and patients than ever before, a testament to the success of legislation established decades ago encouraging the development of these medicines in both the U.S. and European Union.

Orphan medicines were the majority of European Medicines Agency (EMA) approvals for the first time ever in 2016 (59%) and the majority of U.S. Food and Drug Administration (FDA) approvals for the first time ever in 2018 (58%).

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person cuts salami sausage on a wooden cutting board.

Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives

Join the author on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Sven Bostyn

The development of orphan drugs, so named for the rare diseases they treat, has been incentivized through regulation in the European Union. The primary reward is 10 years’ market protection (or exclusivity).

But are these incentive mechanisms working as they should? To date, only 131 orphan drugs have been brought to market. Findings from the European Commission’s long-awaited evaluation of the orphan drug system in Europe, 20 years after its inception, suggest there may be cause for concern.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

Mortal Sins of Orphan Drug Development: How to Save the Lost Souls

Join the authors on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Jakob Wested and John Liddicoat

In a working paper from November 2020, the EU Commission finds a significant inefficiency in the EU orphan drug regulation (a pan-EU piece of legislation): that it does not contain a provision to safeguard the affordability and accessibility of orphan medicines.

The working paper then entertains the idea of inserting such a provision into the regulation. But, is the orphan drug regulation the right place for this type of law?

Diagnosing the problem behind orphan drug pricing is the key issue to address before jumping to consider ways to address excessive pricing.

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