President and CEO, Klote Medical Research Advisors

Molly Klote

Molly Klote, President and CEO, Klote Medical Research Advisors

 spoke with Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, and moderator of the conference's regulatory track panel, about what the industry must do to navigate a rapidly changing supply chain landscape.

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

PharmTech: What Is Driving the Current Push To Rethink Pharmaceutical Supply Chains?

 The pressure extends well beyond tariffs, though tariffs are clearly part of it. Companies are also responding to geopolitical instability, supplier concentration risks, inspection vulnerabilities, shortage exposure, and deep uncertainty around future policy direction. What I'm hearing from people here at the meeting is that the unpredictability may be as disruptive as the cost itself. Companies need to make long-range manufacturing, sourcing, and regulatory decisions, and they're doing so without knowing which countries will reliably serve as sources or what trade conditions will look like 12 to 24 months from now. That volatility is the core challenge.

For years, the default approach was to source from wherever costs were lowest. That model is no longer sustainable on its own. Companies are now asking how they can build in resilience through dual sourcing, qualified backup suppliers, or greater transparency into their tier-two and tier-three suppliers without restructuring their cost base so dramatically that it compromises affordability or patient access.

Is the Industry Actually Moving Manufacturing Back to the United States?

Not wholesale, and I think it's important to be clear about that. Some selective onshoring is happening, and it makes sense in certain contexts. But the more realistic trend is regionalization combined with supply chain redundancy, building in alternatives rather than relocating everything domestically. Not everything can or should be reshored here. The real work is determining which parts of the supply chain are critical enough to justify higher cost or redundancy and then making those changes in a way that doesn't undermine the affordability and availability of medicines for patients. That balance is difficult, and it requires careful, strategic thinking rather than a reactive response to political pressure.

What Will FDA Be Looking for From Companies as They Adapt Their Supply Chain Strategies?

The FDA is not looking for slogans about resilience. Companies need to be prepared to demonstrate through evidence how they are making resilience a reality. That means having current supply chain maps, formal risk assessments, credible alternate-source strategies, realistic regulatory pathways for supplier or site changes, and governance mechanisms that define when and how the organization responds as risks escalate.

A credible resilience strategy must also be quality-led, not simply procurement-driven. For the FDA, the central question will be whether a company understands its vulnerabilities and has a controlled, documented, and regulatorily realistic plan to protect patients if a supplier, site, country, or logistics route becomes unavailable.

What Regulatory Shifts Should Professionals Expect?

Three things stand out. First, there will be more data-driven FDA oversight of supply chains. The agency wants to see what companies are doing more than what they intend to do. Second, companies should anticipate more risk-based and globally consistent inspection oversight for anything that is globally outsourced. Third, there will be stronger expectations around formal quality risk management. Quality must be built in from the start. The FDA's focus is patient safety, and if your systems are not oriented around that, that is where you will run into serious problems.

What Is Your Overall Message to Companies Navigating This Environment?

Act now and act with specificity. The uncertainty in the current environment is not going away, and the companies that will be best positioned, both commercially and regulatorily, are the ones that treat supply chain resilience as a quality and patient safety imperative, not an external compliance requirement. FDA will reward the companies that can demonstrate they understand their risks and have taken documented, defensible steps to address them.

Articles

Escalating tariffs intersect with geopolitical instability, supplier concentration, inspection vulnerabilities, and drug-shortage exposure to force a rethink of pharma supply chains. Unpredictable policy trajectories are as disruptive as direct cost impacts, complicating 12–24 month manufacturing and sourcing commitments. Rather than broad US reshoring, the dominant response is regionalization plus redundancy, emphasizing dual sourcing and deeper tier-2/3 visibility while preserving affordability and access. FDA expectations are shifting toward evidence-based demonstrations of resilience, quality-led governance, formal risk management, and regulatorily executable pathways for supplier and site changes.

Molly Klote, Klote Medical Research Advisors, discusses how pharma must move beyond tariff-driven reactions to build evidence-based, quality-led supply chain resilience that satisfies FDA scrutiny and protects patient access.

Q&A: Molly Klote on Dual Sourcing, Regionalization, and the New Pharma Normal

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.

, 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. Klote emphasized that a credible resilience strategy must be quality-led, not simply procurement-driven. For FDA, the question will be whether a company understands its vulnerabilities and has a controlled, documented, and regulatorily realistic plan to protect patients if a supplier, site, country, or logistics route becomes unavailable.

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 risk-based and globally consistent inspection oversight 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.

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.