Magazines on wooden table on bright background.

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

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 the approval and marketing of biosimilars with a skinny label and their associated Medicare savings, to a discussion of the Philips Respironics recall and the need for reforms to U.S. medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.

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Asthma inhalers on table against blurred background.

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

By Ameet Sarpatwari Liam Bendicksen, 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 January. The selections feature topics ranging from a study of inhaler manufacturers’ revenues after the expiration of primary patents, to an analysis of the clinical value of drugs that companies heavily market to consumers on television, to an exploration of how the public sector and academic institutions have contributed to gene therapy innovation. A full posting of abstracts/summaries of these articles may be found on our website.

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President Joe Biden at desk in Oval Office.

Federalizing Public Health

By Elizabeth Weeks

The most promising path forward in public health is to continue recognizing federal authority and responsibility in this space. I carefully choose “recognizing,” rather than “expanding” or “moving” because it is critical to the argument that federal authority for public health already exists within the federalist structure and that employing federal authority to address public health problems does not represent a dimunition of state authority. Rather than a pie, of which pieces consumed at the federal level necessarily reduce pieces consumable at the state level, we should envision the relationship as a Venn diagram, where increasing overlap strengthens authority for promoting and protecting public health broadly.

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The United States Capitol building at sunset at night in Washington DC, USA

The End of Public Health? It’s Not Dead Yet

By Nicole Huberfeld

Once again, health law has become a vehicle for constitutional change, with courts hollowing federal and state public health authority while also generating new challenges. In part, this pattern is occurring because the New Roberts Court — the post-Ruth Bader Ginsburg composition of U.S. Supreme Court justices — is led by jurists who rely on “clear statement rules.” This statutory interpretation canon demands Congress draft textually unambiguous laws and contains a presumption against broadly-worded statutes that are meant to be adaptable over time. In effect, Congress should leave nothing to the imagination of those responsible for implementing federal laws, i.e., executive agencies and state officials, so everything a statute covers must be specified, with no room for legislative history or other non-textual sources.

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simple black childish hand drawing lines lightbulbs on yellow background.

Failures of Imagination in Public Health Policy

By Daniel Swartzman

If public health is to prosper, we will need to overcome the after-effects of several failures of imagination.

  • Failing to recognize the threat to liberal democracy from the last 50 years of coordinated conservative political and policy actions.
  • Failing to use litigation against inadequate public health actions, as did the early civil rights and environmental movements.
  • Failing to anticipate litigation that challenges our efforts, such as with the ACA or the upcoming attempt to “codify Roe v. Wade.”
  • Failing to demand moral leadership of governmental actors.
  • Failing to make political action and advocacy an integral part of professional education in public health.

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Stethoscope with blue suitcase on a table with American flag as background.

Is a Federal Medical License Constitutional?

By Timothy Bonis

Although three in four doctors support scrapping state medical boards in favor of a single federal license, such sweeping reform is likely far off. It is not just state boards’ political obstructionism standing in the way. Basic constitutional federalism limits Congress’s ability to assume powers traditionally held by the states, leaving medical licensure (a state matter since its 19th-century inception) difficult to federalize.

This post will explore potential constitutional arguments for and against federal licensure, investigate the constitutionality of more moderate legislative approaches, and speculate on how the late Roberts Court might respond to reform attempts.

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Medical student textbooks with pencil and multicolor bookmarks and stethoscope isolated on white.

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

By Ameet Sarpatwari, Alexander Egilman, andAaron 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 November. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with skinny labels and their associated savings to Medicare, a discussion of the Philips Respironics recall and the need for reforms to medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

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

By Ameet Sarpatwari, Liam Bendicksen, Alexander Egilman, andAaron 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 August. The selections feature topics ranging from a discussion of opportunities for improving the use of U.S. Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our website.

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Washington, D.C. skyline with highways and monuments.

COVID-19 as Disability Interest Convergence?

By Jasmine E. Harris

Some have suggested that the COVID-19 pandemic could be a moment of what critical race theorist Derrick Bell called “interest convergence,” where majority interests align with those of a minority group to create a critical moment for social change.

It would be easy to think that interests indeed have converged between disabled and nondisabled people in the United States. From education to employment, modifications deemed “unreasonable” became not only plausible but streamlined with broad support.

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3d render, abstract fantasy cloudscape on a sunny day, white clouds fly under the red gates on the blue sky. Square portal construction.

A Different Future Was Possible: Reflections on the US Pandemic Response

By Justin Feldman

The inadequacies of the early U.S. pandemic response are well-rehearsed at this point — the failure to develop tests, distribute personal protective equipment, recommend masks for the general public, protect essential workers, and take swift action to stop the spread.

But to focus on these failures risks forgetting the collective framing and collective policy response that dominated the first few months of the COVID-19 pandemic. And forgetting that makes it seem as though our current, enormous death toll was inevitable. This dangerously obscures what went wrong and limits our political imagination for the future of the COVID-19 pandemic and other emerging crises.

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