This legislation, titled the "Enhancing Domestic Drug Manufacturing Competitiveness Act" , mandates the Comptroller General of the United States to conduct a comprehensive study. The primary objective of this study is to identify and assess the key regulatory barriers that impede the expansion or siting of new pharmaceutical manufacturing facilities within the United States, or make the country less competitive globally for such facilities. The study will specifically investigate whether environmental and other regulations significantly delay and increase costs for manufacturers compared to other nations, and analyze their potential impact on pharmaceutical supply chain resiliency. Furthermore, it will explore specific actions regulators could take, such as expediting reviews and approvals, to address these identified barriers. In conducting this assessment, the Comptroller General is required to engage various stakeholders to identify barriers, promising technological solutions, and the policies needed to support these solutions. Within one year of enactment, a detailed report must be submitted to Congress, outlining the identified barriers, answering the specified questions, and providing recommendations for streamlining regulations and facilitating technological advancements to boost domestic pharmaceutical manufacturing.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Health
Administrative law and regulatory proceduresCongressional oversightEnvironmental regulatory proceduresGovernment studies and investigationsManufacturingPrescription drugs
Enhancing Domestic Drug Manufacturing Competitiveness Act
USA119th CongressHR-1405| House
| Updated: 2/18/2025
This legislation, titled the "Enhancing Domestic Drug Manufacturing Competitiveness Act" , mandates the Comptroller General of the United States to conduct a comprehensive study. The primary objective of this study is to identify and assess the key regulatory barriers that impede the expansion or siting of new pharmaceutical manufacturing facilities within the United States, or make the country less competitive globally for such facilities. The study will specifically investigate whether environmental and other regulations significantly delay and increase costs for manufacturers compared to other nations, and analyze their potential impact on pharmaceutical supply chain resiliency. Furthermore, it will explore specific actions regulators could take, such as expediting reviews and approvals, to address these identified barriers. In conducting this assessment, the Comptroller General is required to engage various stakeholders to identify barriers, promising technological solutions, and the policies needed to support these solutions. Within one year of enactment, a detailed report must be submitted to Congress, outlining the identified barriers, answering the specified questions, and providing recommendations for streamlining regulations and facilitating technological advancements to boost domestic pharmaceutical manufacturing.
Administrative law and regulatory proceduresCongressional oversightEnvironmental regulatory proceduresGovernment studies and investigationsManufacturingPrescription drugs