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: Sen. Warren, Elizabeth [D-MA]
Target Audience
Population: People benefiting from medical research and innovation funded through FDA and NIH
Estimated Size: 330000000
- The bill targets large drug manufacturers, specifically those with over $1 billion in net income who have entered into settlement agreements for specified violations.
- These manufacturers produce blockbuster drugs, which are defined as those making over $1 billion in net sales and developed partly with federal investment.
- The population directly affected includes the drug manufacturers who will have to allocate a portion of their income to NIH and FDA.
- Indirectly, the population impacted includes researchers who could receive more funding for projects, especially those aligned with the priorities set by NIH and FDA.
- Patients could also benefit from advancements in regulatory science and medical product innovation, especially in areas with high federal healthcare spending.
Reasoning
- The target population affected by this policy is primarily researchers who will receive more funding and patients who may see advancements in drug development. However, these changes may not manifest immediately as the policy initiates a complex funding chain for research.
- Given the budget constraints, the amount of funds available in year 1 ($10,000,000) is relatively small compared to the size of the pharmaceutical market. Thus, immediate impacts on a broad scope are unlikely.
- The policy indirectly affects a large majority of the population through potential improvements in medical research and innovation, particularly over the 10-year timeframe with a more sizeable $100,000,000 budget.
- The Cantril wellbeing scores simulated aim to capture not just direct medical benefits but also perceived improvements in optimism and security regarding future healthcare outcomes.
- Only some segments of the population will feel a high impact as the benefits of medical advancements are often slow and diffused. Not every patient will interact with healthcare improvements immediately.
- There are also segments of the population who may not see a change, or even low impact, due to their healthcare needs not aligning with the advancements achieved through this funding.
- Commonness of a person’s situation considers how widespread reliance on prescription drugs or expectation of healthcare innovation is in the US.
Simulated Interviews
Retired (Florida)
Age: 65 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- I hope this policy will bring down the costs of medications or at least make them safer.
- It's good to see some accountability for drug manufacturers who sometimes charge so much.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 5 | 4 |
Research Scientist (California)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This additional funding can really propel our research into better treatments.
- We rely on grants from NIH, so this policy is a step in the right direction.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Pharmaceutical Sales Representative (Texas)
Age: 54 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- These payments could force manufacturers to cut on jobs or investments.
- I understand the motive but worry about the execution.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 5 | 6 |
| Year 5 | 5 | 6 |
| Year 10 | 5 | 6 |
| Year 20 | 5 | 6 |
Health Policy Analyst (New York)
Age: 44 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- The policy ensures that companies give back to the system that helped them thrive.
- This could set a precedent for more responsible profit-sharing models.
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 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Primary Care Physician (Illinois)
Age: 38 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- This should accelerate the approval of beneficial drugs.
- Better funding for research could lead to more effective treatments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Retired Engineer (Ohio)
Age: 72 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 14/20
Statement of Opinion:
- I hope this leads to better care through the VA.
- Funding research is always good, but I'm more concerned about my current treatments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Healthcare Advocate (Pennsylvania)
Age: 50 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- This could lead to more affordable drugs in the long run or at least safer ones.
- It's progress, but we need more than just funding redirection.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Entrepreneur (Massachusetts)
Age: 34 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 8/20
Statement of Opinion:
- This policy might complicate the market incentives.
- Innovation might be stifled if companies see this as an extra burden rather than a reinvestment.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 6 | 7 |
| Year 20 | 6 | 7 |
Graduate Student (Oregon)
Age: 24 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Redistributing funds to NIH sounds positive for research.
- This policy aligns well with my future aspirations in public health.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Pharmacist (New Mexico)
Age: 60 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- Anything that promotes research and potentially safer drugs is beneficial.
- Drug companies should contribute back when they've profited from public investments.
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 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $10000000 (Low: $5000000, High: $15000000)
Year 2: $10000000 (Low: $5000000, High: $15000000)
Year 3: $10000000 (Low: $5000000, High: $15000000)
Year 5: $10000000 (Low: $5000000, High: $15000000)
Year 10: $10000000 (Low: $5000000, High: $15000000)
Year 100: $10000000 (Low: $5000000, High: $15000000)
Key Considerations
- The inclusion criteria for drug manufacturers are specific, focusing on those with significant federal investment and blockbuster drugs.
- The bill ensures that contributions fluctuate with the income of applicable companies, thus safeguarding their viability.
- The potential for reduced cost growth within federal healthcare programs due to FDA and NIH-supported innovations.