US SB2172 | 2017-2018 | 115th Congress
Status
Spectrum: Moderate Partisan Bill (Democrat 6-1)
Status: Introduced on November 29 2017 - 25% progression, died in committee
Action: 2017-11-29 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on November 29 2017 - 25% progression, died in committee
Action: 2017-11-29 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Summary
Medical Innovation Act of 2017 This bill amends the Public Health Service Act to require 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 settlement agreement in the previous five years with a federal agency regarding specified violations must pay 0.75%-1.5% of its net income to the Department of Health and Human Services (HHS) 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, including a drug for which a patent contains information that relates to, or is based upon, federally funded research. Each fiscal year, HHS must publish a list of manufacturers that make payments, each manufacturer's covered blockbuster drugs, and payment amounts. 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. The FDA's priority use for payments must include advancing regulatory science for medical products. The NIH's priority use for payments must include supporting: (1) research that fosters radical innovation, (2) research that advances fundamental knowledge and technology, (3) research related to diseases that disproportionately account for federal health care spending, and (4) early career scientists. A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and may not be sold until payment is made.
Title
Medical Innovation Act of 2017
Sponsors
Sen. Elizabeth Warren [D-MA] | Sen. Sherrod Brown [D-OH] | Sen. Kirsten Gillibrand [D-NY] | Sen. Al Franken [D-MN] |
Sen. Tammy Baldwin [D-WI] | Sen. Bernard Sanders [I-VT] | Sen. Kamala Harris [D-CA] |
History
Date | Chamber | Action |
---|---|---|
2017-11-29 | Senate | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Same As/Similar To
HB4487 (Same As) 2017-12-01 - Referred to the Subcommittee on Health.
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/115th-congress/senate-bill/2172/all-info |
Text | https://www.congress.gov/115/bills/s2172/BILLS-115s2172is.pdf |