Pharmaceutical Executive Daily: President Trump Pauses Tariff Plan

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, we cover President Trump pausing plans to impose 100% tariffs on branded drugs, the FDA’s operational risks in the event of a 2026 government shutdown, and strategies emerging from recent complete response letters in cell and gene therapy.

President Donald Trump has reportedly paused his plan to impose 100% tariffs on branded and patented pharmaceuticals imported into the U.S. The move had raised alarms across the biopharma sector, with concerns that such tariffs could disrupt supply chains, raise patient costs, and spark retaliatory trade measures. While the pause provides short-term relief for manufacturers and payers, industry analysts caution that tariff discussions may resurface as part of broader debates on U.S. trade and industrial policy, leaving lingering uncertainty for global pharma markets.

Meanwhile, the FDA is preparing for potential disruptions tied to a possible government shutdown in 2026. A new analysis highlights how prolonged funding gaps could affect regulatory review timelines, clinical trial oversight, and inspection schedules. While user fees help shield parts of the agency’s operations, experts warn that shutdowns still risk slowing drug approvals, creating backlogs, and complicating communications with sponsors. For life sciences companies, the report underscores the importance of planning for regulatory contingencies in an unpredictable political environment.

And in product development news, recent FDA complete response letters in the cell and gene therapy space are offering critical insights into CMC strategy. Regulators have consistently flagged issues in manufacturing readiness, scalability, and quality assurance as reasons for delaying approvals. Experts advise companies to engage early with the FDA, invest in robust CMC capabilities, and adopt a proactive approach to regulatory science. With cell and gene therapies advancing rapidly, these lessons highlight how operational execution can be as decisive as clinical data in determining approval timelines.

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