gavel.

Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling

By David Orentlicher

In its regulation of medical devices, the U.S. Food and Drug Administration (FDA) may ban devices that pose “an unreasonable and substantial risk of illness or injury.” But earlier this month, the U.S. Court of Appeals for the D.C. Circuit decided that the FDA may not issue a partial ban of a medical device.

The case, Judge Rotenberg Educational Center v. FDA, addressed the use of electrical stimulation devices to treat self-injurious or aggressive behavior, as in patients with serious intellectual or developmental disabilities.

In March 2020, the FDA attempted to prohibit this use of electrical stimulation (or electrical shock) because of the risks it poses to patients. As the FDA observed, persons with self-injurious or aggressive behavior may have “difficulty communicating pain and other harms caused by” electrical stimulation, and consent to the use of electrical stimulation is typically made by a third party, limiting the patient’s control over use of the device.

In other settings, including smoking cessation treatment, or treatment of substance use disorder, the FDA permits the practice. Hence the partial, rather than total, ban of electrical stimulation devices.

But by a 2-1 vote, the Judge Rotenberg Educational Center court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision. This provision precludes the FDA from limiting or interfering with a health care practitioner’s authority “to prescribe or administer any legally marketed device to a patient for any condition or disease.” In the majority’s view, once the FDA permits use of a medical device, it must defer to the states for regulation of decisions regarding which patients are appropriate candidates for the device.

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Person receiving vaccine.

Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?

Cross-posted from Written Description, where it originally appeared on June 30, 2021. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob S. Sherkow

The number of COVID-19 vaccines is growing, with 18 vaccines in use around the world and many others in development. The global vaccination campaign is slowly progressing, with over 3 billion doses administered, although the percentage of doses administered in low-income countries remains at only 0.3%. But because of differences in how they were tested in clinical trials, making apples-to-apples comparisons is difficult — even just for the 3 vaccines authorized by the FDA for use in the United States. In this post, we explore the open questions that remain because of these differences in clinical trial design, the FDA’s authority to help standardize clinical trials, and what lessons can be learned for vaccine clinical trials going forward.

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Houses.

New Data on Eviction Laws Opens Doors for Evaluation

Even before the COVID-19 pandemic, there was an eviction crisis in the United States. Estimates suggest landlords across the country file 3.7 million eviction cases each year — leaving considerable impacts on health and well-being in their wake. 

The eviction process is regulated by a patchwork of state/territory and local laws and court rules that govern the judicial process, but little is known about the ways in which these laws affect the likelihood of evictions.  

new database, launched by the Legal Services Corporation (LSC) in partnership with the Center for Public Health Law Research, captures the entire eviction legal process, from pre-filing to post-judgment, in different communities around the country.  

The data provide early insights, including: 

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Person filling syringe from vial.

Religious Exemptions to Vaccines and the Anti-Vax Movement

By Dorit Rubinstein Reiss

Two major problems with granting religious exemptions to vaccine mandates are that they are very hard to police, and that they are routinely gamed.

Religious freedom is a core value in the United States. This makes policing religious exemptions to vaccination hard – and rightly so. The government policing people’s religion raises a number of thorny issues.

The problem is that the same people who eagerly promote anti-vaccine misinformation are just as eager to misuse religion to avoid vaccinating, and have no hesitation or compunction about coaching others to do the same. And without policing, it is easy for those misled by anti-vaccine misinformation to use the religious exemption.

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The White House, Washington, DC.

What Can the Federal Government Do When States Make Dangerous Decisions?

By Jennifer S. Bard

The threat posed to the welfare, economy, and security of the United States by the rapidly spreading COVID-19 virus is as serious as any we have ever confronted.

But, at the same time that the federal government is spending billions of dollars on distributing vaccines, and exerting their authority by prohibiting evictions and requiring masks on public transportation, many individual states are not just refusing to take effective measures to stop the spread, but also are pouring gasoline on the fire by doing all they can to undermine even the remaining, weak guidelines published by the CDC. Some have gone so far as to restrict the flow of information by prohibiting public health officials from disseminating news about the vaccines provided by the federal government.

The effects of these actions not only promote the spread of COVID-19, but also fuel its mutation into new forms, and cannot be confined by any existing geographic or cartographic boundary. So how is the federal government allowing this to happen? It’s not for lack of authority.

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Burgess Hill, West Sussex – 12 January, 2021 Covid-19 home PCR self-test kit.

Pandemic Diagnostics: Present and Future Implications of Self-Testing Reimbursement

By David A. Simon

The process of diagnosing a disease or condition, including detection of SARS-CoV-2 infection, is changing.

Consumers now can not only collect their specimen from their living room couch, but they can test it while watching Netflix. Sampling, testing, and obtaining results all can be done in a patient’s home.

For communicable diseases like COVID-19, the disease caused by SARS-CoV-2 infection, at-home testing has considerable public health benefits. In addition to being more convenient than traditional diagnostics, self-testing can substantially reduce or eliminate the risk that infected individuals will spread the virus en route to a testing site.

This innovation has been spurred, in part, by a powerful incentive: the federal government has all-but guaranteed reimbursement for these tests.

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A male pharmacist is examining a drug from a pharmacy inventory.

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

By Ameet SarpatwariBeatrice Brown, Alexander Egilman, 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 June. The selections feature topics ranging from an analysis of the characteristics of clinical studies supporting supplemental indications approved between 2017 and 2019, to an evaluation of the effect of California’s prescription drug coupon ban on generic drug use, to a comparison of how various international regulatory bodies approach postmarket safety communication. A full posting of abstracts/summaries of these articles may be found on our website.

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Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

We Need to Do More with Hospitals’ Data, But There Are Better Ways

By Wendy Netter Epstein and Charlotte Tschider

This May, Google announced a new partnership with national hospital chain HCA Healthcare to consolidate HCA’s digital health data from electronic medical records and medical devices and store it in Google Cloud.

This move is the just the latest of a growing trend — in the first half of this year alone, there have been at least 38 partnerships announced between providers and big tech. Health systems are hoping to leverage the know-how of tech titans to unlock the potential of their treasure troves of data.

Health systems have faltered in achieving this on their own, facing, on the one hand, technical and practical challenges, and, on the other, political and ethical concerns.

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international connections concept art.

The Prospects for an IP Waiver Under the TRIPS Agreement

By Duncan Matthews and Timo Minssen

The informal meeting of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council today, July 6, 2021, focuses international attention once more on prospects for a waiver of the TRIPS Agreement in response to the COVID-19 pandemic.

Regardless of whether an actual TRIPS waiver ultimately comes to pass, the real significance of these efforts lies in the increased focus they have placed on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have introduced the possibility of a rethinking of the relationship between IP, innovation, conservation, and access.

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