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Medical Innovation Act of 2019

USA116th CongressHR-5031| House 
| Updated: 11/12/2019
Peter Welch

Peter Welch

Democratic Representative

Vermont

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Medical Innovation Act of 2019 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 8, 2019
Introduced in House
Nov 8, 2019
Referred to the House Committee on Energy and Commerce.
Nov 12, 2019
Referred to the Subcommittee on Health.
Jan 8, 2020

Latest Companion Bill Action

S 116-3163
Introduced in Senate
  • November 8, 2019
    Introduced in House


  • November 8, 2019
    Referred to the House Committee on Energy and Commerce.


  • November 12, 2019
    Referred to the Subcommittee on Health.


  • January 8, 2020

    Latest Companion Bill Action

    S 116-3163
    Introduced in Senate

Health

Related Bills

  • S 116-3163: Medical Innovation Act of 2020
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 2019

USA116th CongressHR-5031| House 
| Updated: 11/12/2019
Medical Innovation Act of 2019 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 8, 2019
Introduced in House
Nov 8, 2019
Referred to the House Committee on Energy and Commerce.
Nov 12, 2019
Referred to the Subcommittee on Health.
Jan 8, 2020

Latest Companion Bill Action

S 116-3163
Introduced in Senate
  • November 8, 2019
    Introduced in House


  • November 8, 2019
    Referred to the House Committee on Energy and Commerce.


  • November 12, 2019
    Referred to the Subcommittee on Health.


  • January 8, 2020

    Latest Companion Bill Action

    S 116-3163
    Introduced in Senate
Peter Welch

Peter Welch

Democratic Representative

Vermont

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 116-3163: Medical Innovation Act of 2020
  • 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