Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson.

Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson

The COVID-19 pandemic has raised many questions about the regulation of drugs in the United States.

One such concern relates to the use of drugs for treatment of COVID-19 that have not yet been FDA approved.

In this video explainer produced by the James E. Rogers College of Law of The University of Arizona, Christopher Robertson, Professor of Law and Associate Dean for Research & Innovation, discusses these issues, including the Right to Try Act and off-label use of pharmaceuticals, with NYU Grossman School of Medicine’s Alison Bateman-House, MPH, PhD.

Scientist analyzes DNA gel used in genetics, forensics, drug discovery, biology and medicine

Time to Ban Heritable Genome Editing

By Jeffrey R. Botkin, MD, MPH, Professor of Pediatrics and Medical Ethics at University of Utah

We are at a critical crossroad in reproductive medicine.  How should science and society more broadly manage the powerful new technologies that can alter the genes of human embryos?  In a recent paper published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), I argue that banning the use of this technology editing human embryo is the right direction.

Concerns over theoretical capabilities of “designer babies” have been with us for generations.  The ability screen and test for embryos and fetuses with undesirable characteristics and forestall their birth is well-developed and familiar. But the actual ability to add, subtract or alter genes in the embryo is quite new.  The CRISPR-Cas9 technology and related technologies burst on the scene in the last decade and the ability to relatively easily and cheaply to alter human embryos is no longer science fiction.

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An index finger rests on one yellow star while four other stars are shaded to the right, indicating a one star review.

Improving the Mindset on NHS Complaint Handling

By John Tingle

History has not served the NHS (National Health Service) complaints system well

History has not served the NHS complaints system well. There have been many reports about NHS complaints going back well over two and a half decades, saying the same or similar things about the system. Many have argued and continue to argue that the NHS complaints system needs to be much more responsive, simpler in operation and less defensive. It is fair comment to argue today that the NHS complaints system is still plagued with endemic and systemic problems. The NHS has never been able to gets its health care complaints system right.

Two contemporary reports, one published in 2018 and the other in 2020, give support to the view that the NHS needs to do much more to improve how patient complaints are handled. Read More

Soft-focus photograph of wheelchairs lined up in a hospital hallway

Toward a Safer NHS in 2020

By John Tingle

As the New Year begins its important to reflect on the previous year’s National Health Service (NHS) patient safety milestones in England. We should ask also whether the NHS patient safety agenda will make major advances in 2020.

The year 2019 was another bumper year for NHS patient safety policy developments and crises. Some major patient safety publications were produced, and stories of NHS patient safety crisis continued to regularly hit the headlines. The NHS is no sloth when it comes to patient safety policy report writing and the number patient safety adverse incidents happening. Read More

Several vaping devices on a table

E-Cigarette Laws that Work for Everyone

By Daniel Aaron

The Trump Administration has retreated from proposed tobacco regulations that experts generally agree would benefit public health. The regulations would have included a ban on flavored e-cigarettes, a favorite of children who use e-cigarettes. Currently millions of youth are estimated to be addicted to e-cigarettes.

The rules also could have reduced nicotine in cigarettes to non-addictive levels. Nicotine is the addicting substance largely responsible for continued smoking. If nicotine were “decoupled” from smoking, smokers might turn to other sources of nicotine, rather than continuing to smoke. Smoking is the leading cause of preventable death in the U.S., killing about 500,000 Americans each year, or just about the number of Americans who died in World War I and World War II combined.

Part of the difficulty in regulating e-cigarettes is that, unlike cigarettes, they offer benefits and harms that differ across generations. This concern is called intergenerational equity. How can a solution be crafted that serves all Americans?

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Senior female woman patient in wheelchair sitting in hospital corridor with nurses and doctor

Care Quality Commission Annual Assessment of Health and Social Care

By John Tingle

The independent regulator for health and social care in England, the Quality Care Commission (CQC) has recently published its annual report on the real-time state of health and social care in England. It analyses trends, shares examples of outstanding, good, and poor health care care practices. It provides a true, unabashed account of issues facing the National Health Service (NHS) and health care delivery.

A Health System Stretched

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Hand placing wood toy block on top of a tower. The blocks all have images of medical-related items on them, like pills, stethoscope, syringe

Lost in the Jungle of Patient Safety Reports, Publications and Initiatives?

By John Tingle

In terms of the progress of developing a patient safety culture in the National Health Service (NHS) in England, the Daily Telegraph reports comments made by Professor Ted Baker, the Chief Inspector of Hospitals at the Care Quality Commission (CQC) at a recent conference in London. He held the view that “little progress” has been made improving patient safety in the NHS in 20 years, and that never events such as wrong site surgery were still happening because the overall culture is one of defensiveness. The Telegraph reported, “He told The Patient Safety Learning conference that hospital managers routinely hide evidence from the CQC, because they regard the organisation as out to blame them.”

The Telegraph also mentions an NHS estimate in July that 11,000 patients a year may be dying as a result of blunders, partly as a result of a “blame game” culture between staff.

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Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

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Fazal Khan on ‘The Week in Health Law’ Podcast

By Nicolas Terry

This episode was recorded at the annual meeting of the Southeastern Association of Law Schools during a panel reviewing the year in healthcare financing. This episode features a talk by Professor Fazal Khan who teaches Health Law & Policy, Bioethics, Public Health Law and International Products Liability at the University of Georgia School of Law. His current research focuses on several major themes: reform of the American health care system, the effect of globalization on health care, and the challenge of regulating emerging biotechnologies. His talk was on the financing of telemedicine and the slow alignment of the technologies with health care value and other models.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, Spotify, Tunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry and @WeekInHealthLaw.

Subscribe to TWIHL here!