Trump’s Pharmaceutical Tariffs: A New Operating Era for Healthcare
The Trump administration's recent trade and healthcare policies are poised to introduce significant uncertainty into the U.S. healthcare industry. Two pivotal executive actions—the initiation of a Section 232 national security investigation into pharmaceutical imports and the signing of the executive order titled “Lowering Drug Prices by Once Again Putting Americans First”—highlight the administration's approach.
The Trump administration's recent trade and healthcare policies are poised to introduce significant uncertainty into the U.S. healthcare industry. Two pivotal executive actions—the initiation of a Section 232 national security investigation into pharmaceutical imports and the signing of the executive order titled “Lowering Drug Prices by Once Again Putting Americans First”—highlight the administration's approach.
On April 1, 2025, the Department of Commerce commenced a Section 232 investigation to assess the national security implications of importing pharmaceuticals and their ingredients. This encompasses finished drug products, active pharmaceutical ingredients (APIs), and key starting materials. The investigation aims to determine whether reliance on foreign sources compromises national security, potentially leading to the imposition of tariffs ranging from 10% to 25% on these imports.
Simultaneously, President Trump signed the executive order “Lowering Drug Prices by Once Again Putting Americans First” on April 15, 2025. This order seeks to reduce prescription drug costs by enhancing Medicare drug price negotiations, reinstating discounted insulin programs, and increasing transparency in hospital drug acquisition costs.
While these measures aim to bolster domestic manufacturing and reduce drug prices, they introduce several uncertainties:
Supply Chain Disruptions: Tariffs on imported pharmaceuticals could disrupt existing supply chains, leading to potential shortages and increased costs for healthcare providers and patients.
Regulatory Ambiguity: The executive order lacks detailed implementation plans, leaving stakeholders uncertain about how the policies will be enforced and their practical implications.
Market Volatility: The potential for tariffs and changes in drug pricing regulations may lead to market instability, affecting investment decisions within the pharmaceutical industry.
In this evolving landscape, healthcare entities must navigate the complexities of new trade policies and regulatory reforms. Lanton Law offers expertise in crafting targeted messaging and engaging with policymakers to advocate for client interests. Our team is equipped to assist clients in understanding and responding to these changes effectively. Contact us to learn more.
FDA Proposes Rule Impacting Wholesale Drug Distributors & 3rd Party Logistics Providers
According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”
According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”
The rule can be found here. The comment period ends June 6, 2022.
Lanton Law has personal experience in the wholesale distribution industry.
Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our healthcare practice can help distribution stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
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