a pill in place of a model globe

How Do We Arrive at Fair Pricing for COVID-19 Therapies?

By Padmashree Gehl Sampath

As the search for COVID-19 treatments and vaccines continues, questions of pricing and access are beginning to emerge.

How can pharmaceutical companies determine fair prices for these therapies? And how can they ensure that all those who need these treatments are able to access them? These are valid concerns in the current global pharmaceutical landscape, where in recent years, soaring drug prices have been an issue for almost all governments.

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Researcher works at a lab bench

New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs

By Beatrice Brown

As the global pandemic continues, trials have been established to test whether existing drugs such as hydroxychloroquine could be repurposed to treat patients with COVID-19. There are also hopes that a novel drug will surface. But questions remain about when treatments and vaccines will become available.

There is currently great optimism that a treatment or vaccine will be developed quickly, but there is no assurance that such a vaccine or treatment will be highly effective or that normalcy will return in any particular timeframe. A recent study published in the Lancet ID by Jonathan J. Darrow, Mehdi Najafzadeh, Kristina Stefanini, and Aaron S. Kesselheim provides data that might help to temper enthusiasm with evidence.

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Pile of colorful pills in blister packs

Could Vioxx Make a Comeback? Recalled Drug Receives Orphan Designation

By Blake N. Shultz and Gregory Curfman

Despite a troubling history, rofecoxib (Vioxx) may be making a comeback.

The voluntary withdrawal of rofecoxib (Vioxx) from the market in September 2004 marked the end of a controversial era for a once highly profitable and widely used drug. It also marked the beginning of years of high-profile product-liability litigation that would cost Merck billions.

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

By Ameet SarpatwariCharlie LeeFrazer 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from increases in Internet searches for hydroxychloroquine following promotional remarks by the President, to an evaluation of health gains from orphan drugs, to an assessment of clinical trials supporting new FDA drug approvals. A full posting of abstracts/summaries of these articles can be found on our website.

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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.

Stacks of books against a burgundy wall

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.

Below are the abstracts/summaries for papers identified from the month of March. The selections feature topics ranging from the utilization and cost of naloxone for patients at high risk of opioid overdose, to off-label and compassionate drug use in the COVID-19 pandemic, to public-sector financial support and sponsorship for gene therapy trials in the U.S. A full posting of abstracts/summaries of these articles may be found on our website.

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Box of Hydroxychloroquine Tablets

Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II)

By Jennifer S. Bard

This post is the second in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.

In April 2020, Dr. Robin Armstrong, medical director of the Resort, a nursing home in Texas City, Texas, reported “signs of improvement” after he gave hydroxychloroquine, a drug approved by the FDA to treat malaria, to 39 of his nursing home patients who were diagnosed with COVID-19.

At about the same time, information was emerging that now represents the current understanding that hydoxychloroquine isn’t only ineffective in treating COVID-19, but also may cause serious harm to patients. Tensions were raised even higher by the seemingly inexplicable enthusiasm for this treatment by the President and some media outlets.

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Pile of colorful pills in blister packs

How Can the US Address Coronavirus Drug Shortages?

Cross-posted from Written Description, where it originally appeared on April 7, 2020. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob Sherkow

The escalating pandemic has caused devastating shortages not only of ventilators and personal protective equipment like masks, but also of essential medicines needed to treat COVID-19 patients. As detailed by STAT and the New York Times, prescriptions for painkillers, sedatives, anesthetics, and antibiotics are up, but the rate at which prescriptions are filled and shipped to hospitals is down. The FDA helpfully tracks drug shortages, but this doesn’t solve the problem. With the sudden spike in hospitalized patients with COVID-19 symptoms, physicians are using these drugs faster than manufacturers are making them.

What is causing these drug shortages?

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pills

What Does It Mean That Oracle is Partnering with the Trump Administration to Study Unproven COVID-19 Drugs?

Cross-posted from Written Description, where it originally appeared on March 30, 2020. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob Sherkow

One of the dizzying stream of innovation and health law stories to emerge last week is Oracle’s partnership with the White House to study unproven pharmaceuticals for treating COVID-19. We decided to unpack this story for ourselves and then to collectively share our thoughts in a short explainer.

Click here to read the full post at Written Description.