Picture of Ivermectin tablets.

Legal and Ethical Analysis of Court-Ordered Ivermectin Treatment for COVID-19

By Jennifer S. Bard

A judge in Ohio ruled on Monday that a hospital in the region must administer ivermectin to a patient very sick with COVID-19 in their ICU, despite the decision by the medical staff, in agreement with recent statements by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), that ivermectin is not an appropriate treatment, as it has been shown not to work against COVID.

The patient’s prescription came from a doctor who has no authority to treat patients at this particular hospital, although he is licensed to prescribe medicine in Ohio.

This case tracks a swelling interest, which some ascribe to the efforts of a group called America’s Front Line Doctors, among people for the anti-parasitic medication as both a treatment and prophylactic for COVID-19 — despite warnings from the medical establishment that it doesn’t work, and, if taken in the form normally given to farm animals or at the dosages being suggested, can be harmful.

The Ohio ruling is just the latest of several successful law suits (see similar cases in New York and Illinois) to order hospitals to administer ivermectin to hospitalized COVID-19 patients, despite the objections of the treating physicians.

There is also evidence of a global trend, as evidenced by the order of a court in South Africa to allow the prescription of ivermectin for COVID-19, something that was previously not permitted by the country’s drug regulatory agency.

This trend of courts ordering that treatments requested by hospitalized patients be made available by that hospital — so long as they are prescribed by a physician — opens the door to substantial administrative, legal, and ethical chaos. This post analyzes some of the most pressing legal, regulatory, and ethical concerns.

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Should We Regulate Direct-to-Consumer Health Apps?

By Sara Gerke and Chloe Reichel

According to one estimate, over 318,000 health apps are available in app stores, and over 200 health apps are added each day. Of these, only a fraction are regulated by the U.S. Food and Drug Administration (FDA); those classified as “medical devices,” which typically pose a moderate to high risk to user safety.

In this final installment of our In Focus Series on Direct-to-Consumer Health Apps, we asked our respondents to reflect on this largely unregulated space in health tech.

Specifically, we asked: How can/should regulators deal with the assessment of health apps? For apps not currently regulated by the FDA, should they undergo any kind of review, such as whether they are helpful for consumers?

Read their answers below, and explore the following links for their responses to other questions in the series.

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Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

How Social Movements Have Facilitated Access to Abortion During the Pandemic

By Rachel Rebouché

Before the end of 2021, the U.S. Food and Drug Administration (FDA) will reconsider its restrictions on medication abortion. The FDA’s decision could make a critical difference to the availability of medication abortion, especially if the Supreme Court abandons or continues to erode constitutional abortion rights.

Under that scenario of hostile judicial precedents, a broad movement for abortion access — including providers, researchers, advocates, and lawyers — will be immensely important to securing the availability of remote, early abortion care.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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 July. The selections feature topics ranging from a discussion of issues related to FDA’s approval of aducanumab for the treatment of Alzheimer’s disease, to an analysis of the communication of survival data in cancer drug labels, to an evaluation of public-sector contributions to novel biologic drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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President Joe Biden and Vice President Kamala Harris.

6 Actions the Federal Government Should Take in Response to the Delta Variant

By Jennifer S. Bard

Today, the U.S. Centers for Disease Control and Prevention took an important step in protecting the nation’s health by reinstating indoor masking for both vaccinated and unvaccinated alike, in particularly high-risk circumstances. That’s good. And so is the jump in institutions like the Veterans Health Administration requiring COVID-19 vaccination.

But we need to take more forceful action, and it needs to happen faster.

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Person typing on computer.

COVID-19 and the New Reproductive Justice Movement

By Mary Ziegler

The COVID-19 pandemic has transformed advocacy for reproductive rights and reproductive justice in what previously had been called an endless, unchanging, and intractable abortion conflict.

The pandemic — and the stay-at-home orders it required — finally shifted the movement’s focus to abortion access, rather than abortion rights, as exemplified by its emphasis on medication and telehealth abortion.

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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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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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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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