Policy Impact Analysis - 117/HR/9687

Bill Overview

Title: Medical Innovation Act of 2022

Description: 2022 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.

Sponsors: Rep. Welch, Peter [D-VT-At Large]

Target Audience

Population: People globally who may benefit from pharmaceutical advancements funded by FDA and NIH research

Estimated Size: 330000000

Reasoning

Simulated Interviews

retired teacher (Florida)

Age: 70 | Gender: female

Wellbeing Before Policy: 5

Duration of Impact: 20.0 years

Commonness: 10/20

Statement of Opinion:

  • I'm hopeful that increased funding for medical research could lead to more effective treatments for my condition.
  • It's crucial that pharmaceutical companies contribute to advancements since they benefit from taxpayer-funded research.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 5 5
Year 2 5 5
Year 3 6 5
Year 5 6 5
Year 10 7 6
Year 20 8 6

biotech researcher (California)

Age: 45 | Gender: male

Wellbeing Before Policy: 7

Duration of Impact: 20.0 years

Commonness: 5/20

Statement of Opinion:

  • This policy could provide a crucial boost to our research projects, potentially accelerating breakthroughs.
  • However, there's a need for careful balancing to ensure companies aren't overly burdened.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 7 7
Year 2 8 7
Year 3 8 7
Year 5 9 7
Year 10 9 8
Year 20 9 8

pharmaceutical executive (Texas)

Age: 52 | Gender: female

Wellbeing Before Policy: 8

Duration of Impact: 10.0 years

Commonness: 3/20

Statement of Opinion:

  • While the idea of supporting research is commendable, the financial implications for large companies could affect our profitability.
  • We might need to reconsider drug pricing to offset these costs.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 8 8
Year 2 7 8
Year 3 7 8
Year 5 7 8
Year 10 7 8
Year 20 8 8

public health official (New York)

Age: 35 | Gender: male

Wellbeing Before Policy: 6

Duration of Impact: 15.0 years

Commonness: 4/20

Statement of Opinion:

  • The potential advancements in research can significantly improve public health outcomes.
  • Monitoring and evaluation will be key to ensuring appropriate allocation and use of funds.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 6 6
Year 2 6 6
Year 3 7 6
Year 5 7 6
Year 10 8 7
Year 20 8 7

community organizer (Ohio)

Age: 60 | Gender: other

Wellbeing Before Policy: 6

Duration of Impact: 20.0 years

Commonness: 7/20

Statement of Opinion:

  • If well-managed, this could make new treatments accessible faster to those in need, reducing inequalities.
  • Success depends heavily on how funds are directed towards community health needs.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 6 6
Year 2 6 6
Year 3 7 6
Year 5 8 6
Year 10 8 7
Year 20 9 7

clinical trial participant (Illinois)

Age: 30 | Gender: female

Wellbeing Before Policy: 5

Duration of Impact: 20.0 years

Commonness: 8/20

Statement of Opinion:

  • I hope this leads to more advanced and safer medication trials.
  • The possibility of quicker access to lifesaving drugs is exciting.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 5 5
Year 2 6 5
Year 3 7 5
Year 5 8 6
Year 10 9 6
Year 20 9 6

small business owner (Georgia)

Age: 40 | Gender: male

Wellbeing Before Policy: 7

Duration of Impact: 10.0 years

Commonness: 10/20

Statement of Opinion:

  • Increased innovation could expand the range of treatments we can offer, benefiting our customers.
  • However, we need to watch for price shifts that could affect drug affordability.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 7 7
Year 2 7 7
Year 3 7 7
Year 5 7 7
Year 10 8 7
Year 20 8 7

graduate student (Washington)

Age: 28 | Gender: female

Wellbeing Before Policy: 6

Duration of Impact: 15.0 years

Commonness: 6/20

Statement of Opinion:

  • This is a compelling policy case study for how public funds can drive scientific advancement.
  • Trackable outcomes will provide rich data for future research.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 6 6
Year 2 7 6
Year 3 7 7
Year 5 8 7
Year 10 8 7
Year 20 9 8

healthcare consultant (Pennsylvania)

Age: 50 | Gender: male

Wellbeing Before Policy: 7

Duration of Impact: 5.0 years

Commonness: 9/20

Statement of Opinion:

  • The burden on pharmaceutical companies might shift drug development priorities.
  • Balancing corporate and public interest here will be crucial.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 7 7
Year 2 7 7
Year 3 7 7
Year 5 7 7
Year 10 8 8
Year 20 8 8

retired nurse (Arizona)

Age: 65 | Gender: female

Wellbeing Before Policy: 7

Duration of Impact: 20.0 years

Commonness: 5/20

Statement of Opinion:

  • I see potential for better patient care as new treatments become available due to increased research funding.
  • However, there must be transparency in how funds are allocated and results shared with the public.

Wellbeing Over Time (With vs Without Policy)

Year With Policy Without Policy
Year 1 7 7
Year 2 7 7
Year 3 8 7
Year 5 8 7
Year 10 9 8
Year 20 9 8

Cost Estimates

Year 1: $50000000 (Low: $30000000, High: $70000000)

Year 2: $52000000 (Low: $32000000, High: $72000000)

Year 3: $54000000 (Low: $34000000, High: $74000000)

Year 5: $58000000 (Low: $37000000, High: $79000000)

Year 10: $66000000 (Low: $42000000, High: $90000000)

Year 100: $110000000 (Low: $70000000, High: $150000000)

Key Considerations