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Pharmaceutical Supply Chain Defense and Enhancement Act

USA117th CongressS-1366| Senate 
| Updated: 4/26/2021
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Cosponsors (1)
Tina Smith (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Pharmaceutical Supply Chain Defense and Enhancement Act This bill requires the Department of Health and Human Services (HHS) to enter into contracts with U.S. entities to manufacture certain critical drugs within the United States. The Food and Drug Administration (FDA) must periodically report to Congress a list of drugs that are critical to public health or national security. The Biomedical Advanced Research and Development Authority within HHS must enter into contracts for qualified U.S. entities to manufacture in the United States the drugs on this list (and ingredients for such drugs). Such contracts must impose certain conditions, such as requiring the manufacturing entity to (1) develop and maintain a redundancy risk management and continuity of business plan, and (2) commit to selling the drugs and ingredients manufactured under the contract at reasonable prices. Beginning in FY2025, certain federal agencies, including the Department of Defense and the Bureau of Prisons, must give priority, in procuring drugs on the FDA critical drugs list, to those that are manufactured in the United States and of high quality. The bill also requires the Federal Trade Commission to submit annually to Congress a report on foreign investment in the U.S. pharmaceutical industry. The report must address, among other topics, the effect of the industry's reliance on foreign manufacturing.
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Timeline

Bill from Previous Congress

S 116-4175
Pharmaceutical Supply Chain Defense and Enhancement Act
Apr 26, 2021
Introduced in Senate
Apr 26, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-4175
    Pharmaceutical Supply Chain Defense and Enhancement Act


  • April 26, 2021
    Introduced in Senate


  • April 26, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • S 117-1367: United States Pharmaceutical Supply Chain Review Act
  • HR 117-6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022
Congressional oversightDrug safety, medical device, and laboratory regulationForeign and international corporationsGeneticsGovernment information and archivesGovernment studies and investigationsHealth care coverage and accessHealth technology, devices, suppliesIndustrial policy and productivityManufacturingPrescription drugsPublic contracts and procurementRetail and wholesale tradesStrategic materials and reservesU.S. and foreign investmentsWorld health

Pharmaceutical Supply Chain Defense and Enhancement Act

USA117th CongressS-1366| Senate 
| Updated: 4/26/2021
Pharmaceutical Supply Chain Defense and Enhancement Act This bill requires the Department of Health and Human Services (HHS) to enter into contracts with U.S. entities to manufacture certain critical drugs within the United States. The Food and Drug Administration (FDA) must periodically report to Congress a list of drugs that are critical to public health or national security. The Biomedical Advanced Research and Development Authority within HHS must enter into contracts for qualified U.S. entities to manufacture in the United States the drugs on this list (and ingredients for such drugs). Such contracts must impose certain conditions, such as requiring the manufacturing entity to (1) develop and maintain a redundancy risk management and continuity of business plan, and (2) commit to selling the drugs and ingredients manufactured under the contract at reasonable prices. Beginning in FY2025, certain federal agencies, including the Department of Defense and the Bureau of Prisons, must give priority, in procuring drugs on the FDA critical drugs list, to those that are manufactured in the United States and of high quality. The bill also requires the Federal Trade Commission to submit annually to Congress a report on foreign investment in the U.S. pharmaceutical industry. The report must address, among other topics, the effect of the industry's reliance on foreign manufacturing.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 116-4175
Pharmaceutical Supply Chain Defense and Enhancement Act
Apr 26, 2021
Introduced in Senate
Apr 26, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-4175
    Pharmaceutical Supply Chain Defense and Enhancement Act


  • April 26, 2021
    Introduced in Senate


  • April 26, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Cosponsors (1)
Tina Smith (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 117-1367: United States Pharmaceutical Supply Chain Review Act
  • HR 117-6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulationForeign and international corporationsGeneticsGovernment information and archivesGovernment studies and investigationsHealth care coverage and accessHealth technology, devices, suppliesIndustrial policy and productivityManufacturingPrescription drugsPublic contracts and procurementRetail and wholesale tradesStrategic materials and reservesU.S. and foreign investmentsWorld health