US HB5031 | 2019-2020 | 116th Congress
Status
Spectrum: Partisan Bill (Democrat 1-0)
Status: Introduced on November 8 2019 - 25% progression, died in committee
Action: 2019-11-12 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on November 8 2019 - 25% progression, died in committee
Action: 2019-11-12 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
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.
Title
Medical Innovation Act of 2019
Sponsors
Sen. Peter Welch [D-VT] |
History
Date | Chamber | Action |
---|---|---|
2019-11-12 | House | Referred to the Subcommittee on Health. |
2019-11-08 | House | Referred to the House Committee on Energy and Commerce. |
2019-11-08 | House | Introduced in House |
Same As/Similar To
SB3163 (Related) 2020-01-08 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Subjects
Appropriations
Civil actions and liability
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Executive agency funding and structure
Food and Drug Administration (FDA)
Fraud offenses and financial crimes
Health
Health technology, devices, supplies
Medical research
National Institutes of Health (NIH)
Prescription drugs
Research administration and funding
Civil actions and liability
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Executive agency funding and structure
Food and Drug Administration (FDA)
Fraud offenses and financial crimes
Health
Health technology, devices, supplies
Medical research
National Institutes of Health (NIH)
Prescription drugs
Research administration and funding
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/116th-congress/house-bill/5031/all-info |
Text | https://www.congress.gov/116/bills/hr5031/BILLS-116hr5031ih.pdf |