Tariffs, FDA Chaos, And BioSecure In Limbo: How CDMOs Should Operate Under Uncertainty

If you think the tariff situation is complex, wait until you factor in simultaneous FDA workforce cuts and a BioSecure Act that's neither dead nor moving. Gil Roth, President of the Pharma and Biopharma Outsourcing Association (PBOA), laid out the full picture for CDMO Live Europe delegates, and it's not a comforting one.

On tariffs: the Supreme Court struck down the original Liberation Day tariffs, so the administration pivoted to Section 232 national security probes, a legally defensible mechanism. The outcome is a 100% tariff on pharma imports from countries without US trade agreements. The EU, UK, Japan, and South Korea get a 15% cap with pathways to zero for orphan drugs and antibody drug conjugates (ADCs). India and China face the full rate unless clients have onshoring agreements, which reduces exposure to 20%.

The headline onshoring numbers from major pharma are also worth scrutinizing. J&J, Pfizer, Merck, and AstraZeneca have announced enormous US investment figures, but Roth flagged that many bundle R&D, ongoing operations, and pre-existing commitments. Regeneron's initial figure was an existing Fujifilm Diosynth contract.

For CDMOs, the investment scale is different, but the strategic stakes aren't. Access the full analysis to build a more accurate picture of your regulatory exposure.