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Medical Innovation Act of 2020

USA116th CongressS-3163| Senate 
| Updated: 1/8/2020
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Cosponsors (4)
Kamala D. Harris (Democratic)Sherrod Brown (Democratic)Bernard Sanders (Independent)Tammy Baldwin (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Medical Innovation Act of 2020 This bill requires certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a relevant settlement agreement regarding specified violations must pay 0.75%-1.5% of its net income to the Department of Health and Human Services for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed, in whole or in part, through federal investments in medical research. Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year. Priorities for payments must include advancing regulatory science for medical products and research related to diseases that disproportionately account for federal health care spending. A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and subject to prohibitions on introducing or receiving misbranded drugs in interstate commerce.
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Timeline
Nov 12, 2019

Latest Companion Bill Action

HR 116-5031
Referred to the Subcommittee on Health.
Jan 8, 2020
Introduced in Senate
Jan 8, 2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • November 12, 2019

    Latest Companion Bill Action

    HR 116-5031
    Referred to the Subcommittee on Health.


  • January 8, 2020
    Introduced in Senate


  • January 8, 2020
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 116-5031: Medical Innovation Act of 2019
AppropriationsCivil actions and liabilityDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationExecutive agency funding and structureFood and Drug Administration (FDA)Fraud offenses and financial crimesHealth technology, devices, suppliesMedical researchNational Institutes of Health (NIH)Prescription drugsResearch administration and funding

Medical Innovation Act of 2020

USA116th CongressS-3163| Senate 
| Updated: 1/8/2020
Medical Innovation Act of 2020 This bill requires certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a relevant settlement agreement regarding specified violations must pay 0.75%-1.5% of its net income to the Department of Health and Human Services for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed, in whole or in part, through federal investments in medical research. Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year. Priorities for payments must include advancing regulatory science for medical products and research related to diseases that disproportionately account for federal health care spending. A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and subject to prohibitions on introducing or receiving misbranded drugs in interstate commerce.
View Full Text

Suggested Questions

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

Timeline
Nov 12, 2019

Latest Companion Bill Action

HR 116-5031
Referred to the Subcommittee on Health.
Jan 8, 2020
Introduced in Senate
Jan 8, 2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • November 12, 2019

    Latest Companion Bill Action

    HR 116-5031
    Referred to the Subcommittee on Health.


  • January 8, 2020
    Introduced in Senate


  • January 8, 2020
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Cosponsors (4)
Kamala D. Harris (Democratic)Sherrod Brown (Democratic)Bernard Sanders (Independent)Tammy Baldwin (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 116-5031: Medical Innovation Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
AppropriationsCivil actions and liabilityDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationExecutive agency funding and structureFood and Drug Administration (FDA)Fraud offenses and financial crimesHealth technology, devices, suppliesMedical researchNational Institutes of Health (NIH)Prescription drugsResearch administration and funding