Regulatory Relief to Promote Domestic Production of Critical Medicines
Reduces regulatory barriers to domestic pharmaceutical manufacturing to reduce dependence on foreign (primarily Chinese and Indian) drug supply chains.
Section by Section
What each section does, and how they differ.
Strengthens oversight and security of biological research through regulatory streamlining and accountability.
Agencies to ensure domestic pharmaceutical manufacturing capacity while maintaining biosecurity standards.
FDA to review regulations on pharmaceutical manufacturing within 180 days; eliminate duplicative requirements and streamline approvals.
FDA to develop risk-based inspection regime for overseas pharmaceutical facilities; disclose annual inspection data by country within 90 days.
EPA to update regulations within 180 days; eliminate duplicative requirements for pharmaceutical manufacturing facilities.
EPA designated lead agency for pharmaceutical manufacturing permits requiring environmental impact statements.
Army to review nationwide permits for pharmaceutical facilities within 180 days.
Standard boilerplate: preserves existing agency authority, conditions the order on appropriations, and creates no enforceable private rights.