President and CEO, Klote Medical Research Advisors

Molly Klote

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, speaks on how the pharma industry faces tariff volatility and reshoring pressure. She warns FDA wants actionable supply chain plans, not slogans, with quality built in.

Molly Klote on Reshoring, Tariffs, and the Future of Pharma Supply Chains

, Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, sat down with 

 to share her perspective on the forces reshaping pharma's supply chain strategy and what companies must do to stay ahead of evolving FDA expectations.

On the supply chain front, Klote explains that manufacturers can no longer simply chase the lowest-cost sourcing options. Tariff pressures and domestic reshoring policies are pushing companies to build in redundancy through dual sourcing and other resilience strategies. At the same time, she cautions that a wholesale shift to US-based manufacturing isn't realistic and that getting the cost calculus wrong could ultimately threaten patient access. "Figuring out how they can do that in the most affordable way without changing the cost structure so much that it makes accessibility or availability to patients impossible" is the central tension companies are grappling with, she notes.

Perhaps more unsettling than the tariffs themselves, however, is the uncertainty surrounding them. Based on her conversations with industry peers at the conference, Klote identifies volatility and unpredictability, not cost alone, as the primary supply chain concern for companies trying to plan long-range.

On the regulatory side, she outlines three trends she expects to define the FDA's posture going forward: more data-driven oversight of supply chains, more aggressive inspection of globally outsourced operations, and stronger requirements for formal quality risk management. Her message to manufacturers is, "The FDA is not looking for slogans from companies. They are looking for actionable plans and what you're doing." Quality, she emphasizes, must be built into systems from the ground up, not bolted on, given the agency's unwavering focus on patient safety.

Articles

Pharma supply chains are being reshaped by tariffs, reshoring incentives, and a shift from lowest-cost sourcing toward resilience via redundancy, including dual sourcing. A full pivot to US manufacturing remains impractical, and misjudging the cost equation risks undermining patient access. Greater disruption stems from tariff volatility and planning uncertainty rather than price alone. FDA expectations are trending toward more data-driven supply chain oversight, intensified inspection of globally outsourced operations, and stricter, formalized quality risk management requiring concrete, operational plans with quality embedded by design.

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, not slogans, with quality built in.