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US Administration Signals Potential Changes to Inflation Reduction Act Drug Price Negotiations

In what appears to be a response to manufacturer complaints regarding “black box” Inflation Reduction Act (IRA) drug price negotiations, the US administration issued a statement on January 29, 2025, stating it planned to...more

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

Trump Executive Order Signals Drug Pricing Reforms Likely on the Horizon

Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more

How the US Election May Affect Drug Pricing, Medicare, and Medicaid Programs – Key Areas to Watch

Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more

The Ins and Outs of Medicare’s Prescription Payment Plan

Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government....more

Delaware Court Rules Inflation Reduction Act’s Drug Price Negotiation Program to Remain Intact

The US District Court of Delaware recently ruled against AstraZeneca in its case challenging the constitutionality of Medicare’s new Drug Price Negotiation Program (the Program). The court, in granting the federal...more

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