Bill of Health - Globe and vaccine, covid vaccine

Reclaiming Global Public Health

By Zain Rizvi

By December 2020, the world had astonishingly powerful tools against COVID-19. New mRNA vaccines, underpinned by decades of public investment, had been authorized by global regulators. Yet the promise of the vaccines was unevenly realized: deep fault lines emerged between those who were able to secure vaccines and those left behind, or what South Africa’s president Cyril Ramaphosa called “vaccine apartheid.”

Dose shortages elevated the role of pharmaceutical executives. Fielding calls from heads of state, they decided what vaccine deliveries to prioritize, shaping which countries could protect lives and livelihoods. The answer to one of the most important public health questions of our time — who gets access to vaccines? — was mostly determined neither by political representatives nor scientists, but by corporate executives.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market

By Jonathan Perez-Reyzin

Within the psychedelic legal landscape, the U.S. Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use.

But for many working in drug policy, medicalization is not the exclusive goal. Indeed, there have been calls for legalization of psychedelics for non-medical use — and we are seeing an early attempt at such a model in Oregon.

These efforts are not yet reaching the federal level, but it’s only a matter of time before the legalization of psychedelics and other currently illegal drugs for adult recreational use becomes a federal question, as is already occurring with marijuana. And despite the FDA’s widely recognized role in medicine, few have considered the role the FDA would play in a federal regulatory regime for the non-medical use of drugs, even though it already does regulate at least one recreational substance legal for recreational use: tobacco.

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Group of athletic adult men and women performing sit up exercises to strengthen their core abdominal muscles at fitness training.

Exercise Equipment Advertisements and Consumer Distrust

By Jack Becker

Are you ready to learn about “the most innovative piece of exercise equipment ever”? To take advantage of “the momentum of gravity to target your entire midsection”? Doesn’t everybody want to “lose those love handles nobody loves”? To finally “have the flat washboard abs and the sexy v-shape [they’ve] always wanted”? Within “just weeks, not months,” anybody can “firm and flatten their stomach.” And “best of all, it’s fun and easy and takes just three minutes a day.”

Despite its endorsement from an expert fitness celebrity and customer testimonials, you might be skeptical of the Ab Circle Pro’s claims. After all, can you really cut out five minutes from the iconic 8-Minute Abs routine?

Massive and misleading promises are an unfortunate reality for many exercise equipment advertisements. Illegitimate advertising claims can harm consumers and impact overall consumer trust, which creates an uphill battle for honest companies. The Federal Trade Commission (FTC) already regulates exercise equipment, but supplementing its efforts with more consumer education and industry self-regulation could be a winning combination to restore trust in the fitness industry.

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Waiting area in a doctor's office

Churntables: A Look at the Record on Medicaid Redetermination Plans

By Cathy Zhang

The COVID-19 Public Health Emergency (PHE) expires at the end of this week, with Department of Health and Human Services (HHS) Secretary Xavier Becerra expected to renew the PHE once more to extend through mid-July.

When the PHE ultimately expires, this will also trigger the end of the Medicaid continuous enrollment requirement, under which states must provide continuous Medicaid coverage for enrollees through the end of the last month of the PHE in order to receive enhanced federal funding. This policy improves coverage and helps reduce churn, which is associated with poor health outcomes.

After the PHE, states can facilitate smooth transitions for those no longer eligible for Medicaid by taking advantage of the full 12- to 14- month period that the Centers for Medicare & Medicaid Services (CMS) has established for redetermining eligibility.

In August 2021, CMS released guidance giving states up to 12 months following the end of the PHE to redetermine whether Medicaid enrollees were still eligible and renew coverage. Last month, CMS released new guidance specifying that states must initiate redeterminations and renewals within 12 months of the PHE ending, but have up to 14 months to complete them. The agency is encouraging states to spread its renewals over the course of the full 12-month unwinding period, processing no more than 1/9th of their caseloads in a month, in order to reduce the risk of inappropriate terminations.

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Bill of Health - Globe and vaccine, covid vaccine

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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Person in nursing home.

Struggles Over Care Will Shape the Future of Work

By Andrew Milne

The future of work will largely be the future of care work. Health care is rapidly becoming the largest employer in the U.S., expanding to serve the fastest growing demographic, aging seniors. As a lawyer for seniors in need of free legal services, I see my clients struggle to access care made scarce by the for-profit care industry’s understaffing and underpaying of workers attempting to meet the growing need. The future of work and of aging will be shaped by struggles over care from both giving and receiving ends, perhaps against those profiting in between.

Recall that the first COVID-19 outbreak in the U.S. spread between nursing homes. These facilities, like most nursing homes, are for-profit businesses that pad their margins by cutting labor costs. The resulting understaffing has deadly effects in normal times. The pandemic intensified those effects, as underpaid care workers, forced to work at multiple facilities to survive, unintentionally spread the virus between facilities.

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College football on grass field in afternoon sunlight

There’s More Than Rules in Regulating Concussions

By Jack Becker

The football world has used a variety of methods to make the sport safer: Compare modern football to football a century ago, when at least 18 people died playing the game in 1905 alone and Teddy Roosevelt had to intervene. In recent years, concussions and brain trauma have become football’s scarlet letter. While leagues have already made changes to prevent brain injuries, there’s more to be done.

This post considers the application of Lawrence Lessig’s New Chicago School approach to regulation to the prevention of concussions (and other types of brain damage generalized under the word “concussions” for simplicity) in football.

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Field hospital in NY during COVID-19 pandemic.

Systemic Failures Need Systemic Solutions: COVID-19 and Macromedical Regulation

By Barak D. Richman and Steven L. Schwarcz

Among the many failures to mitigate the harm from COVID-19 in the U.S. has been the failure to meet surging demand for inpatient care. Hospital bed shortages, overwhelmed intensive care nurses, and scarcities of needed medical equipment have been embarrassing but constant features of the American health care landscape. A nation that spends nearly one out of every six dollars on health care should get much, much more for its money.

Though there is much blame to go around — and many insightful commentators have already allocated culpability — we observe that a significant regulatory deficiency has contributed to the nation’s failure to meet population health needs. This is the failure to regulate our hospitals holistically, as part of a comprehensive health care system.

Existing health care regulation focuses almost exclusively on regulating individual components of the health care industry. This existing regulation lacks the capacity to address how those components work together as a system — a system in which deficiencies in one component adversely impact the performance of the other components. We should not view hospitals as individual providers that treat individual patients. Instead, they are part of a larger safety net that needs to expand capacity when emergencies arise. Today’s pandemic destabilized hospital care because hospitals were neither coordinated nor managed systemically in order to meet population demands.

In Macromedical Regulation, 82 Ohio State Law Journal 727 (2021), we address the nation’s systemic failure to contain an infectious contagion, and we offer solutions by deriving lessons from the 2008 financial contagion. We contend that health care regulation must also include what we call “macromedical” regulation: regulation that focuses on protecting the stability of the health care sector as a system of interconnected parts.

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