House Appropriations  

Full Committee

Bill language:

• Title VI, page 72. Appropriate $10 million to the Center for Drug Evaluation and Research for pilots to increase unannounced foreign inspections. 

Report language:

• Page 7: DirectsUSDA, in coordination with EPA and FDA, to submit a report that develops a framework for regulating biotechnology products as platforms and reviews the use of “regulatory sandboxes” and short-term pilots for new regulatory pathways. For the framework, USDA, EPA, and FDA can move towards interoperable data management systems and standardized applications. 
• Page86: Encourages FDA to continue advancing regulatory and manufacturing pathways for genetically modified cell-based therapies. Urges FDA to identify opportunities to increase predictability and efficiencies for the Investigational New Drug application process. 
• Page91: Encourages the FDA to use AI to streamline its review and approval process.  
• Page92: Encourages the FDA to improve staff retention and hiring. 
• Page 98: Recognizes the importance of U.S. participation in international standards setting bodies for biotechnology, especially in the face of China’s increasing participation, and encourages the FDA to continue being a leader in these bodies. 
• Page100: Supports FDA initiatives to use New Approach Methodologies (NAMs) to support safety and efficacy testing of human pharmaceuticals. 
• Page 107: Directs the FDA to review, update, and streamline its Investigational New Drug submission guidance; to develop and implement a pilot program for Australian-like clinical trial notification system; and to expand opportunities for engagement with biotechnology start-ups. 
• Clinical Trial Data from Foreign Adversaries. Prohibits the FDA from accepting, reviewing, or considering any covered clinical data generated by a clinical investigation site locatedin a covered nation in support of an investigational new drug application, starting one year after the enactment of the bill. 
• Biobased Markets Program. Directs USDA to prioritize available resources to accelerate product certification and audits under the BioPreferredprogram, expand designated product categories, strengthen Federal procurement compliance, and improve access for small and mid-sized domestic manufacturers.