Episode 1: API Stockpiling and U.S. Pharma Supply - Insights from PBOA’s Gil Roth

On August 16, the administration issued an executive order to fill the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). The plan begins by stockpiling a six-month supply of 26 critical drugs, with the goal of expanding to a list of 86 essential medicines. What does this mean for pharmaceutical manufacturing, contract development and manufacturing organizations (CDMOs), and the broader drug supply chain?

In this episode of BWS Dialogues, we sit down with Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA), to unpack the implications of this initiative. Gil shares insights and offers a candid look at the opportunities, challenges, and unintended consequences.

We explore questions such as:

• How does this plan build on—and differ from—previous U.S. drug stockpiling efforts?

• What short- and long-term impacts could this initiative have on pharmaceutical manufacturing and the CDMO sector?

• How effective are other recent measures, like accelerated FDA plant approvals, the PreCheck program, and EQUIP-A-Pharma in supporting U.S.-based drug manufacturing?

• How would pharmaceutical tariffs affect innovators, generics companies, and CDMOs?

• What other factors need to be considered to make reshoring efforts work?

Gil offers his perspectives on how these programs intersect, what gaps remain, and what it will take to build a more resilient pharmaceutical supply chain in the United States.

Learn More & Connect!

• Visit brandwidthsolutions.com for more information about our services!

• Connect with our guest, Gil Roth: LinkedIn

• Connect with our podcast host, Laura Bush: LinkedIn