A fresh attempt to bring more pharmaceutical manufacturing back to US soil has put the sector on alert, as a new executive order from Donald Trump seeks to overhaul how American medicines are made and regulated.
Signed on May 5, the order directs the US regulator to speed up approvals for domestic drug manufacturing sites while increasing oversight and fees for foreign producers. Though intended to boost American production, the policy has been met with widespread uncertainty, especially over how it will be applied in practice.
Industry observers are asking whether the changes will affect all overseas facilities or target certain plants, production lines or product types. The lack of implementation details has left stakeholders navigating what many view as regulatory limbo.
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