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

At CPHI Americas 2026, PharmTech 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.

Watch the video interview with Klote:

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

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

Klote: 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.