Colorful magazines.

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 August. The selections feature topics ranging from a review of the regulatory consequences of the FDA’s accelerated approval of eteplirsen, to a comparison of the safety and effectiveness of generic and brand-name fluticasone-salmeterol for COPD, to an analysis of free speech challenges to Medicare drug price negotiation under the Inflation Reduction Act. A full posting of abstracts/summaries of these articles may be found on our website.

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Blood glucose monitor and insulin.

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 June. The selections feature topics ranging from a review of modifications to blood glucose monitoring systems and related patent protections, an examination of insulin price changes from 2012-2019, and a discussion of why a proposed federal bill that would ban government health care programs from using the quality-adjusted life-year is misguided. A full posting of abstracts/summaries of these articles may be found on our website.

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Pharmacist with a prescription looking at a medicine box on a pharmacy shelf.

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 May. The selections feature topics ranging from an investigation of federal support for the development of expensive HIV drugs, to an analysis of COPD exacerbations and hospitalizations among new users of maintenance inhalers, to a comparison of sales for new drugs with and without an initial orphan drug designation. A full posting of abstracts/summaries of these articles may be found on our website.

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Magazines on wooden table on bright background.

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

By Ameet Sarpatwari, Aviva Wang, 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 April. The selections feature topics ranging from an analysis of government and industry investments for recently approved drugs, to a discussion of court decisions on mifepristone, and an examination of the added therapeutic benefit associated with the top-selling brand-name drugs in Medicare.

A full posting of abstracts/summaries of these articles may be found on our website.

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Medical Development Laboratory: Caucasian Female Scientist Looking Under Microscope, Analyzes Petri Dish Sample. Specialists Working on Medicine, Biotechnology Research in Advanced Pharma Lab.

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 March. The selections feature topics ranging from an analysis of patent challenges by generic manufacturers on brand-name inhalers, a discussion of the Alliance for Hippocratic Medicine v. FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public investment in the development of mRNA COVID-19 vaccines. A full posting of abstracts/summaries of these articles may be found on our website.

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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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pills

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

By Ameet SarpatwariAviva 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from a discussion of antitrust as a tool to address patent thickets, to an analysis of the relationship between price and efficacy for recently approved cancer drugs, to an examination of the viability and implications of preemption challenges to state laws restricting medication abortion.

A full posting of abstracts/summaries of these articles may be found on our website.

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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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Bill of Health - American currency (50, 100, 20) on a wooden table next to pills and spilling bottle of pharmaceuticals

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

By Ameet SarpatwariAviva WangLiam 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 October. The selections feature topics ranging from newly enacted incentives for increasing diversity in clinical trials, to an analysis of how patients’ out of pocket costs changed after biosimilar versions of infliximab entered the US market, to an evaluation of how manufacturers have navigated postmarket requirements for drugs recently approved by the FDA. A full posting of abstracts/summaries of these articles may be found on our website.

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