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The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted. [ABSTRACT FROM AUTHOR]

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a "taking" of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US's most important state and federal health care programs. [ABSTRACT FROM AUTHOR]

Since 2004, the US Food and Drug Administration (FDA) has had the authority to allow access to unapproved medical products via the Emergency Use Authorization (EUA) pathway during times of emergency. It was rarely used until the COVID-19 pandemic, when concerns arose regarding the role of political pressure in the FDA's issuance of some EUAs, such as for hydroxychloroquine. Although US government officials should be responsive to the public, democratic accountability must be balanced against the need for thoughtful science-based decision-making. Inadequate agency independence can diminish public confidence in government leaders and the FDA. To consider whether reform of the EUA process might be appropriate, we considered three possible sources of inspiration for balancing independence and accountability in government scientific decision-making: models in other countries, models in other US agencies, and models within the FDA itself. Strategies used in these settings include: (1) expanding the role of advisory committees, (2) increasing transparency of the agency's decision-making process and supporting rationale, and (3) improving management of internal agency disagreement. Such reforms could improve public trust in public health regulation both related to and separate from future emergencies. [ABSTRACT FROM AUTHOR]

This cross-sectional study identifies the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competition. [ABSTRACT FROM AUTHOR]

Glucagon-like peptide-1 receptor agonists are effective for treating obesity, but the high cost of these medications endangers the financial viability of our health care system. To ensure that these drugs are available to Medicare beneficiaries, pharmaceutical manufacturers must lower their prices. [ABSTRACT FROM AUTHOR]

Patents prevent generic drug entry. Brand firms file new "method of use" patents for old drugs to prevent generic entry. Congress addressed this issue by creating the "skinny label" pathway, which allows generic firms to use the drug label to indicate that the old drug can only be used for non‐patented uses. This pathway is now in jeopardy due to a recent court case. This paper outlines the issues and suggests possible legislative solutions. [ABSTRACT FROM AUTHOR]