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, Aviva 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 February. The selections feature topics ranging from an analysis of how the Bayh-Dole Act can be updated to promote innovation and affordable access to drugs developed using federal funds, to an examination of the upcoming reauthorization of the Prescription Drug User Fee Act and its implications for FDA regulation and policies, to a systematic review and meta-analysis of preapproval clinical testing of biosimilars used in the treatment of cancer. A full posting of abstracts/summaries of these articles may be found on our website.

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close up of hands signing contract.

Using Contracts to Lessen Inequities in Access to Medicines in Pandemics and Epidemics

By Sapna Kumar and Ana Santos Rutschman

Research funding contracts can help to safeguard against profound inequities in global allocation and distribution of lifesaving diagnostics, drugs, and vaccines.

During large transnational public health crises, global demand soars for diagnostics, drugs, and vaccines. Although some of these products can be developed within compressed timelines, global production capacity remains limited. Against a backdrop of product scarcity, wealthier countries can out-bid their lower-income counterparts and capture most of the supply during the early stages of pandemics and epidemics. This leaves the vulnerable low-income populations waiting months, or even years, for their turn.

This predictable, inequitable pattern can be held off before the next pandemic. At the research and development (R&D) stage, government funders can bind producers to equity goals through targeted contractual provisions, as we explain in a recently-published Nature Biotechnology article. We summarize our proposals in the following sections. Read More

Healthcare concept of professional psychologist doctor consult in psychotherapy session or counsel diagnosis health.

A Precautionary Approach to Touch in Psychedelic-Assisted Therapy

By Neşe Devenot, Emma Tumilty, Meaghan Buisson, Sarah McNamee, David Nickles, and Lily Kay Ross

Amid accelerating interest in the use of psychedelics in medicine, a spate of recent exposés have detailed the proliferation of abuse in psychedelic therapy, underscoring the urgent need for ethical guidance in psychedelic-assisted therapies (P-AT), and particularly relating to touch and consent.

Acknowledging the need for such guidance, McLane et al. outline one set of approaches to touch in a recent Journal of Medical Ethics blog. However, we find their piece at odds with the available information in the fields of P-AT and psychotherapy. We explain three major concerns: consent and autonomy, risk mitigation, and evidence and reasoning. In our view, these concerns merit a precautionary approach to touch in P-AT, given the current state of research on touch-based interventions.

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Large pile of amber prescription pill bottles

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

By Ameet Sarpatwari, Alexander Egilman, Beatrice Brown, 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 January. The selections feature topics ranging from a discussion of why state laws restricting mifepristone access may be subject to federal preemption, to an analysis of patents impacting the availability of biosimilars, to an evaluation of the hypothetical out-of-pocket costs of guideline-recommended medications for the treatment of older adults with multiple chronic diseases. A full posting of abstracts/summaries of these articles may be found on our website.

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Cigarettes.

Tobacco Issues Awaiting Robert Califf at the FDA

By Cathy Zhang

Yesterday, the Senate confirmed Dr. Robert Califf for his second, non-consecutive term as Commissioner of the U.S. Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions.

Prior to his first term as Commissioner during the Obama administration, Califf, a cardiologist, served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.

In addition to fielding scrutiny over mifepristone access, reviewing opioid regulations, and handling COVID-19 vaccine and treatment approvals in the midst of a pandemic, Califf will be overseeing the FDA at a time when public health advocates are anticipating agency action on several tobacco issues.

Two major developments expected in this area include a menthol ban and greater regulation of e-cigarettes.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

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Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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One pill on mint green background.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva 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 December. The selections feature topics ranging from a discussion of the challenges in confirming drug effectiveness after early approval, to an analysis of potential savings from a proposed policy requiring manufacturers of drugs receiving accelerated approval to pay higher rebates to Medicaid until efficacy is demonstrated, to an evaluation of the racial and ethnic representation in clinical trials supporting FDA approval of new drugs and biologics. A full posting of abstracts/summaries of these articles may be found on our website.

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Suboxone.

Eliminating Barriers to Opioid Use Disorder Treatment

By Jennifer D. Oliva, Taleed El-Sabawi, and Shelly Weizman

The tragedy of the ever-worsening drug poisoning and overdose crisis in the United States is compounded by a simple fact: We know how to prevent overdose deaths, and yet, the overwhelming majority of individuals with opioid use disorder (OUD) lack access to the lifesaving, standard of care treatment.

Research demonstrates that the opioid agonist medications methadone and buprenorphine are the safest and most effective treatments for OUD. As the National Academy of Sciences explained in a 2019 report, these two medications reduce risk of death by up to 50 percent and are associated with numerous other benefits, including improved quality of life, reduced rates of use of other opioids, and reduced risk of contracting illnesses including HIV and hepatitis C.

However, during the worst drug poisoning crisis in U.S. history, which is now killing more than 100,000 people a year, the country’s outdated and restrictive federal regulatory schemes that pertain to methadone and buprenorphine present a pernicious and persistent barrier to accessing OUD medications.

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