How the New Executive Order on Drug Pricing Could Impact Clinical Trials and Comparator Sourcing

Earlier this month, the US President signed a landmark executive order aimed at delivering “most favored nation” (MFN) pricing for prescription drugs in the United States. As outlined in the official White House release and covered by Reuters, the order seeks to tie US drug prices to those paid in other developed nations, potentially slashing prices by up to 59%.

While much of the media focus has been on the implications for American patients, this shift also raises important questions for the pharmaceutical industry globally, especially in the area of clinical trials and comparator sourcing.

What Could This Mean for Clinical Trials?

The United States has long been the world’s most expensive market for prescription drugs. Sponsors planning global clinical trials often face disproportionately high costs when sourcing comparator drugs in the US If this executive order leads to significant price reductions, it could:

• Lower comparator drug costs in the US, making U.S.-sourced products more attractive in global studies.

  
  

• Influence global sourcing strategies, especially for trials requiring U.S.-sourced reference products due to regulatory or study design requirements.

  
  

• Encourage sponsors to re-evaluate US as a supply hub for global studies, given improved cost efficiency.

Implications for Comparator Sourcing

At CSI, we specialize in comparator sourcing across all therapeutic areas, with direct access to manufacturers in the US, Europe, and beyond. If the U.S. market becomes more cost-competitive, we could see:

• Increased demand for US-sourced comparators in global trials.

  
  

• Sponsors prioritizing US comparators to align with FDA expectations while managing budgets more efficiently.

  
  

• Potential shifts in global sourcing patterns, depending on how manufacturers respond to pricing pressures.

  
  

With a strong presence in the US market and an office based in Philadelphia, CSI is uniquely positioned to support clients navigating this changing landscape. Our team’s expertise in US regulatory requirements, commercial networks and domestic distribution channels ensures that we can efficiently source, manage, and deliver US-sourced comparators. This local infrastructure allows us to act quickly and cost-effectively as policy shifts unfold, helping sponsors mitigate risk and take full advantage of emerging opportunities in the American market.

A Wait-and-See Moment

At this stage, the operational details of the executive order, including how it will be enforced, remain unclear. Manufacturer responses will also play a critical role. However, this is a pivotal development that could reshape drug pricing not only for patients but also for the clinical trial supply chain.

As industry experts in comparator sourcing and supply strategy, CSI will be closely monitoring these changes and advising our partners on how best to navigate the evolving landscape.

If you're planning a trial and want to discuss how this may impact your sourcing strategy, get in touch with our team. We’re here to help you stay ahead of regulatory and market developments that affect your study timelines and budgets.

Reach out with your US enquiry