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S. 3398

BillFederalSenateIn Committee
To amend the Public Health Service Act to establish an Office of Drug Manufacturing.
About This Bill
Committee
Latest Action · December 5, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congress
118th (2023–2025)
Introduced
December 5, 2023
Cosponsors (1)
1D 0R
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Summary

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This bill establishes a new Office of Drug Manufacturing within the Department of Health and Human Services to produce affordable prescription drugs and lower medication costs. The Office would be headed by a presidential appointee and would focus on manufacturing drugs that are expensive, in short supply, or difficult to access, with specific emphasis on insulin, asthma and COPD inhalers, naloxone, epinephrine auto-injectors, and antibiotics. The legislation requires the Office to begin manufacturing at least one insulin product and one inhaler within one year, produce at least 15 different drugs within a year and 25 drugs within three years, and price medications based on factors including manufacturing costs and patient access. The bill includes safeguards preventing pharmaceutical company lobbyists and executives from companies under federal settlement from working at the Office, requires all pricing information be made public, and mandates annual reports to Congress on the program's impact on drug competition and costs. The bill authorizes whatever funding is necessary to operate the Office without specifying an exact budget amount.

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