Legis Daily

Pandemic Emergency Manufacturing Act of 2021

USA117th CongressS-187| Senate 
| Updated: 2/3/2021
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Pandemic Emergency Manufacturing Act of 2021 This bill establishes within the Department of Health and Human Services (HHS) an Emergency Office of Manufacturing for Public Health to manufacture and distribute medical products to address COVID-19 (i.e., coronavirus disease 2019) or medical products that are on shortage or vulnerable to shortage. The office must (1) obtain the rights to manufacture the applicable medicines, ingredients, diagnostic tests, medical devices, personal protective equipment, and supplies; (2) manufacture or contract to manufacture such items; and (3) construct, or enter into construction contracts for, facilities to manufacture certain medicines, such as vaccines. HHS may issue involuntary licenses allowing the office to make, use, sell, import, or export an invention related to an applicable drug, biological product, or device and to use clinical trial data and confidential information. Such a license must provide the rights holder with reasonable compensation. The office must (1) provide such COVID-19 products at no cost to federal, state, local, and other health programs and certain domestic health care providers and suppliers; (2) offer COVID-19 products at cost to other commercial and international entities; and (3) offer other medical products to entities at a fair price, based on cost and other considerations. The office shall prioritize the manufacture of certain COVID-19 products and meet manufacturing timelines specified in the bill.
View Full Text

Suggested Questions

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

Timeline
Feb 3, 2021

Latest Companion Bill Action

HR 117-728
Referred to the Subcommittee on Health.
Feb 3, 2021
Introduced in Senate
Feb 3, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • February 3, 2021

    Latest Companion Bill Action

    HR 117-728
    Referred to the Subcommittee on Health.


  • February 3, 2021
    Introduced in Senate


  • February 3, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 117-728: Pandemic Emergency Manufacturing Act of 2021
Blood and blood diseasesCardiovascular and respiratory healthCongressional oversightCorporate finance and managementDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careExecutive agency funding and structureFederal officialsGeneticsGovernment ethics and transparency, public corruptionGovernment information and archivesGovernment studies and investigationsHealth personnelHealth technology, devices, suppliesImmunology and vaccinationIndian social and development programsInfectious and parasitic diseasesInflation and pricesLicensing and registrationsManufacturingMarketing and advertisingMedical tests and diagnostic methodsMinority healthPrescription drugsPublic contracts and procurementPublic participation and lobbyingState and local government operationsStrategic materials and reservesWorker safety and health

Pandemic Emergency Manufacturing Act of 2021

USA117th CongressS-187| Senate 
| Updated: 2/3/2021
Pandemic Emergency Manufacturing Act of 2021 This bill establishes within the Department of Health and Human Services (HHS) an Emergency Office of Manufacturing for Public Health to manufacture and distribute medical products to address COVID-19 (i.e., coronavirus disease 2019) or medical products that are on shortage or vulnerable to shortage. The office must (1) obtain the rights to manufacture the applicable medicines, ingredients, diagnostic tests, medical devices, personal protective equipment, and supplies; (2) manufacture or contract to manufacture such items; and (3) construct, or enter into construction contracts for, facilities to manufacture certain medicines, such as vaccines. HHS may issue involuntary licenses allowing the office to make, use, sell, import, or export an invention related to an applicable drug, biological product, or device and to use clinical trial data and confidential information. Such a license must provide the rights holder with reasonable compensation. The office must (1) provide such COVID-19 products at no cost to federal, state, local, and other health programs and certain domestic health care providers and suppliers; (2) offer COVID-19 products at cost to other commercial and international entities; and (3) offer other medical products to entities at a fair price, based on cost and other considerations. The office shall prioritize the manufacture of certain COVID-19 products and meet manufacturing timelines specified in the bill.
View Full Text

Suggested Questions

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

Timeline
Feb 3, 2021

Latest Companion Bill Action

HR 117-728
Referred to the Subcommittee on Health.
Feb 3, 2021
Introduced in Senate
Feb 3, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • February 3, 2021

    Latest Companion Bill Action

    HR 117-728
    Referred to the Subcommittee on Health.


  • February 3, 2021
    Introduced in Senate


  • February 3, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-728: Pandemic Emergency Manufacturing Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Blood and blood diseasesCardiovascular and respiratory healthCongressional oversightCorporate finance and managementDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careExecutive agency funding and structureFederal officialsGeneticsGovernment ethics and transparency, public corruptionGovernment information and archivesGovernment studies and investigationsHealth personnelHealth technology, devices, suppliesImmunology and vaccinationIndian social and development programsInfectious and parasitic diseasesInflation and pricesLicensing and registrationsManufacturingMarketing and advertisingMedical tests and diagnostic methodsMinority healthPrescription drugsPublic contracts and procurementPublic participation and lobbyingState and local government operationsStrategic materials and reservesWorker safety and health