Tag: Drug Pricing

Blood glucose monitor and insulin.

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Alexander Egilman, 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 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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Narcan Naloxone nasal spray opioid drug overdose prevention medication.

Public Health Product Hops

The Petrie-Flom Center Staff 1 Comment

By Michael S. Sinha, Edna Besic, and Melissa Mann

Members of Congress have been focused on drug pricing for the last several years, culminating recently in new drug pricing provisions within the Inflation Reduction Act of 2022. One reason for our drug pricing problem is that we allow manufacturers to charge whatever the market will bear for a new therapeutic. However, as we have also seen, manufacturers often engage in anticompetitive “games” aimed at extending market exclusivity and forestalling generic competition. One of these games is product hopping.

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pills

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, 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 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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A male pharmacist is examining a drug from a pharmacy inventory.

HHS’ New Prescription Drug and Health Care Spending Rule

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By Cathy Zhang

Today, the Department of Health and Human Services — alongside the Department of Labor, the Department of the Treasury, and the Office of Personnel Management — published an interim final rule requiring health insurance plans and issuers on the marketplace to report data on prescription drug and health care spending to the three Departments.

This rule is part of a series of rules issued by the Biden Administration to implement Title I (No Surprises Act) and Title II (Transparency) of the Consolidated Appropriations Act, 2021.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

What Democrats’ Drug Pricing Plan Means for Consumers

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By Cathy Zhang

At the start of the month, Democrats announced a new drug pricing plan, detailed in the House’s Build Back Better Act (H.R. 5376). In the immediate short term, the drug pricing plan has enabled the $1.75 trillion bill to go forward through the House. If ultimately enacted, it will generate savings for consumers, some more directly than others, and at a more modest pace and magnitude than many had hoped.

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close up of an open book

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

Ameet Sarpatwari Leave a comment

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 September. The selections feature topics ranging from an analysis of the regulatory outcomes of cancer drugs that received accelerated approval and had negative post-approval trials, to an evaluation of how federal public funding contributed to the development of Pregabalin (Lyrica), to a systematic literature review of the criticisms against the use of the quality-adjusted life-year (QALY) in health technology assessments. A full posting of abstracts/summaries of these articles may be found on our website.

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a pill in place of a model globe

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, 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 May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Hundred dollar bills rolled up in a pill bottle

New Rule Might Increase Out-of-Pocket Drug Costs for Patients

The Petrie-Flom Center Staff Leave a comment

This blog post is adapted from a commentary published in the American Journal of Managed Care.

By Bryan Walsh and Aaron S. Kesselheim

Patients may face increased out-of-pocket drug costs as a result of a new rule finalized by the Centers for Medicare & Medicaid Services (CMS) in July 2020 that would permit wide use of co-pay accumulator adjustment programs (CAAPs).

These increased costs may have effects on medication adherence, and in turn may affect health outcomes. In a recent commentary published in the American Journal of Managed Care, we explain the background to this rule and suggest ways CMS could narrow it to avoid these potential negative effects.

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Gavel surrounded by piles of money.

3 Challenges to Patents on Therapeutic Monoclonal Antibodies

The Petrie-Flom Center Staff Leave a comment

By Gregory Curfman

Three new developments — two based on litigation and one based on a federal statute — may have significant effects on pharmaceutical manufacturers’ use of patents to fend off competition and maintain high prices for therapeutic monoclonal antibodies.

Highly specific monoclonal antibodies have played an increasingly important role as precision therapies for a growing number of diseases, including malignant, cardiovascular, and inflammatory conditions. As therapies derived from research and development, therapeutic monoclonal antibodies may be — and usually are — patented, providing manufacturers with protection from competition and the prospect of high revenues.

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Map of United States made up of pills.

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, 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 an analysis of recent regulatory and legal developments in drug-pricing transparency, to an argument for the extent to which political actors should have influence over the FDA, to a descriptive analysis of state-level drug product selection laws. A full posting of abstracts/summaries of these articles may be found on our website.

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