Tag: covid-19 testing

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.

COVID-19 and the FDA Emergency Use Authorization Power

The Petrie-Flom Center Staff Leave a comment

By Anne Kapnick

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs.[1] In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices.[2] The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”[3] This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.

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Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

Federal COVID-19 Response Unlawfully Blocks State Public Health Efforts

The Petrie-Flom Center Staff Leave a comment

By Barbara J. Evans and Ellen Wright Clayton

The federal government recently used preemption unlawfully to prevent state public health efforts to protect vulnerable people from COVID-19.

As 1,000 current and former CDC epidemiologists noted in an open letter, the federal government has failed to use legal powers it does have to manage the crisis, leaving states to “invent their own differing systems” to manage COVID-19. We add that the federal government is now asserting emergency powers it does not have to disable state public health responses.

Early this month, Nevada officials halted the use of two rapid coronavirus tests that produced high false-positive rates when used for screening vulnerable people in Nevada’s nursing homes, assisted-living, long-term care, and other congregate facilities. More than half the positive test results were false.

On October 8, the U.S. Department of Health and Human Services (HHS) sent a letter threatening that the Nevada officials’ action was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” Nevada yielded to this threat and, on October 9, removed its directive to stop using the tests.

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Up close shot of an orange prison jumpsuit

COVID-19 and Women in the US Criminal Legal System

The Petrie-Flom Center Staff Leave a comment

By Cynthia Golembeski, Carolyn Sufrin, Brie Williams, Precious Bedell, Sherry Glied, Ingrid Binswanger, Donna Hylton, Tyler Winkelman, and Jaimie Meyer

Health and economic inequities exacerbated by the COVID-19 pandemic disproportionately harm women, and particularly women of color, involved in the criminal legal system.

Structural racism, sexism, poverty, substandard healthcare in jails and prisons, and the health effects of incarceration worsen women’s health. The pandemic only compounds these effects. Often overlooked or less visible, incarcerated women are at significantly increased risk of acquiring infectious illness, including COVID-19.

Alternatives to incarceration, and care continuity for chronic health conditions, including substance-use and psychiatric disorders, which disproportionately affect women, are necessary within the current pandemic and beyond.

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Austin, Tx/USA - May 23, 2020: Family members of prisoners held in the state prison system demonstrate at the Governor's Mansion for their release on parole due to the danger of Covid-19 in prisons.

Jails and COVID-19: An Overlooked Public Health Crisis in Philadelphia

Temple University Center for Public Health Law Research Leave a comment

By Katherine Zuk

Since the start of the pandemic, jails and prisons have continuously struggled to stop the spread of COVID-19 cases.

The novel coronavirus has been ravaging the U.S. since late February, with over 6 million cases and 185,092 deaths. Emerging data shows alarmingly high rates of COVID-19 in jails and prisons nationwide, including over 85% of inmates testing positive at two facilities in Ohio. As of September 3, there have been at least 180,045 cases and 928 deaths in prisons alone – and many fear these numbers are severely underreported.

Philadelphia offers an unfortunate case study.

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

Great Responsibility: Navigating Moral Hazards During COVID-19

The Petrie-Flom Center Staff Leave a comment

By Jacqueline Salwa

Younger people may be driving the COVID-19 pandemic in part because they perceive the costs of complying with public health measures as higher and the expected benefits as lower compared with older individuals.

”Indemnifying Precaution: Economic Insights for Regulation of a Highly Infectious Disease,” a paper recently published in the Journal of Law and the Biosciences, explores how to align costs and benefits so that individuals of all ages adhere to precautions.

Younger people tend to experience less severe symptoms from COVID-19 infection, and may be disproportionately affected by other aspects of the pandemic.  These include depression from lack of social interaction, stifled career advancement, and difficulties with providing for dependents.  Compared to younger people, older people have a greater chance of being settled down, retired, and not responsible for dependents. As a result, those that  receive the least benefit from taking precautions, and incur the greatest personal costs for abiding by these precautions, have a lack of incentive to follow precautionary public health measures. This is known, in economic terms, as a moral hazard.

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basketball on court

The Long-Term Harm of Favoritism in COVID-19 Testing

Paul C. McLean Leave a comment

By Jonathan M. Marron and Paul C. McLean

One of us is a sports fan, childhood cancer doctor, and bioethicist. The other is a former sportswriter drawn to medical ethics since the cure of his only child. If sports and ethics have something in common, it’s the value of a level playing field. Fairness matters. There’s a coin toss: heads or tails. Fairness, not favoritism.

We view the doctor-patient relationship through slightly different lenses, but it’s precious either way. It’s a relationship — above all else — built on trust. And that relationship, a cornerstone of healthcare, is suddenly like an already vulnerable person facing an uncertain prognosis. If the doctor-patient relationship is to survive the novel coronavirus (COVID-19) pandemic, it will require a unified team, trust, and a level playing field, regardless of how much money or influence you have.

What does sports have to do with this?

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