Episode 9: Pharmaceutical Tariffs and FDA Disruptions—Analysis from Gil Roth

On April 2, 2026, the US administration announced pharmaceutical tariffs under Section 232 of the Trade Expansion Act of 1962, which take effect on July 31 for larger companies and on September 29 for all others. The headline rate is 100%, but the real story lies in the maze of exemptions and reduced rates based on drug type, country of origin, and whether a company has announced US manufacturing investment or signed a Most Favored Nation pricing agreement with the government. To unpack the implications for the industry — and especially for CDMOs — we sat down with Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA). The conversation also led us to the potential impact of recent FDA disruptions on CDMOs. We discussed: · How the exemptions actually work (and are ADCs truly exempt?) · Why small- and mid-sized pharma companies may take the hardest hit · What a closer look at pharma investment announcements reveals · How steel tariffs (and other trade moves) are rippling into pharma · The "force multiplier" effect of CDMO expansions · Will FDA staff cuts slow down tech transfer approvals for US-based CDMOs? · The broader impact of FDA disruption, including politicized decision-making · The catch-22 of CDMO facility investments · Why CDMOs are pushing for more—and earlier—FDA inspections Tune in as Gil untangles the details and tells us what it all really means. **Update!** One question we discussed was resolved after we recorded this interview: The US Department of Commerce published a clarification around Section 232 implementation and noted that tech transfer to a US domestic CDMO *does* count as onshoring. **Learn more & connect!** · Read the details of the tariff announcement. ·. Connect with our guest, Gil Roth: LinkedIn · Learn more about the Pharma & Biopharma Outsourcing Association (PBOA) · Connect with our podcast host, Laura Bush: LinkedIn · Visit brandwidthsolutions.com to learn how we support CDMOs and other companies in life sciences and technology industries.