Large pile of amber prescription pill bottles

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 links to the papers identified from the month of May. The selections feature topics ranging from the association between clinical benefit of approved cancer drugs and their prices in the U.S. and Europe, to an assessment of how commercial health plans cover biosimilars relative to their reference products, to a commentary on how children should be included in clinical trials evaluating COVID-19 therapies. A full posting of abstracts/summaries of these articles can be found on our website.

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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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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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gavel on top of a pile of bills and pills

A Local City Takes on Pharma

By Phebe Hong

A city northwest of Atlanta is taking on Big Pharma. On February 6th, the city of Marietta filed a lawsuit in federal court in Atlanta against Mallinckrodt, a global specialty pharmaceutical company. The class action complaint alleges that Mallinckrodt is “unjustly enriched” by its “exorbitant and unconscionable prices” for Acthar, a therapeutic adrenocorticotropic hormone (ACTH) approved in 1952 and indicated for various disease conditions, most notably infantile spasms and multiple sclerosis relapse. Marietta brings the class action suit on behalf of itself and “[a]ll third-party payors and their beneficiaries and people without insurance” that have paid for Acthar in the past four years.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part III)

By Jonathan Darrow

This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here.

A Path Forward

The small number of biosimilar approvals compared to generic drug approvals cannot establish the failure of the BPCIA due to differences in industry familiarity with each follow-on pathway, the number of reference products available for copying, patient population sizes, patent barriers, and drug costs. The later arrival of US laws and guidance documents—not inadequate legal design—is the most straightforward explanation of why the first US biosimilar approvals were delayed compared to those in Europe.

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Ambassador-at-Large Deborah Birx giving a speech from a podium with an American flag and PEPFAR banner in the background

One of the Biggest Public Health Initiatives in History: PEPFAR and HIV

By Daniel Aaron

In October, the Petrie-Flom Center hosted a conference of world-leading experts in HIV/AIDS to discuss one of the biggest public health successes in history: PEPFAR, the President’s Emergency Plan for AIDS Relief. PEPFAR was launched in 2003 in response to a burgeoning global epidemic of HIV. The program offered $2 billion annually, rising to about $7 billion in 2019, to surveil, diagnose, treat, and reduce transmission of HIV around the world.

PEPFAR prevented what could have become an exponentially growing epidemic. It is estimated to have saved more than 17 million lives and avoided millions of new HIV infections. As a result, the speakers at the conference were quick to extol the virtues of the program. Professor Ashish Jha called it an “unmitigated success”; Professor Marc C. Elliott named it a “historic effort”; Dr. Ingrid Katz described PEPFAR as “nothing short of miraculous.”

However, several undercurrents within the conference, as well as more explicit points made by several panelists, suggested the importance of enlarging the discussion beyond PEPFAR itself to include other policies that impact HIV and AIDS, and even other diseases.

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illustration of abstract ecnomics

The Need for an Economic Bioethics

As the animations of markets increasingly shape the timbre and character of medicine, scholars studying ethical issues in health and medicine must be increasingly attentive to the role of market forces as they shape modern health care.

For those interested in the social, ethical, and conceptual dimensions of contemporary health and medicine, there has been a sustained focus on a key set of important challenges; how do we ensure adequate access to health for marginalized and global populations? What are the social and ethical implications of emergent technologies? How are issues of consent articulated in the everyday interactions of the clinic? What are our obligations to persons in terms of end-of-life care? These longstanding concerns regarding access, new technologies and the rights of patients comprise the major thrusts and foci of bioethics, health care ethics, and associated areas of inquiry.

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Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

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