Policy Whiplash in Pharma: Navigating Volatility with Strategic Clarity

At the heart of this moment is a growing unpredictability in how U.S. healthcare policy is being shaped.

Tariffs on active pharmaceutical ingredients (APIs) and raw materials are driving up costs, threatening margins.

Manufacturers must reframe this as a macroeconomic inevitability to preserve pricing integrity.

Tying drug prices to international benchmarks could erode pricing power—especially in specialty and oncology.

Launch pricing strategies for pipeline assets may need to be re-evaluated.

FDA reviews, CMS rulemaking, reports used to calculate Medicaid rebates, and IRA guidance are at risk of delay.

This creates uncertainty around regulatory timelines and payer formulary updates.

Adjust launch roadmaps and account for trickle-down effects for inventory and launch execution.

Pharmaceutical companies face policy unpredictability and volatility.

PharmExec — 2025-10-13