Bill Overview
Title: To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.
Description: This bill requires the Food and Drug Administration to update its regulations relating to the manufacture of human cells, tissue, and cellular and tissue-based products (HCT/Ps), including an update to the definition of minimal manipulation . (The regulations are commonly referred to as the tissue rules ; HCT/Ps that are minimally manipulated and meet other criteria are not regulated as drugs, devices, or biologics and therefore are not subject to premarket review.)
Sponsors: Rep. Crenshaw, Dan [R-TX-2]
Target Audience
Population: People using or producing human cell and tissue-based products
Estimated Size: 200000000
- The bill impacts regulations concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).
- Producers and developers of HCT/Ps will need to comply with updated FDA regulations, possibly affecting manufacturing processes.
- Healthcare providers using these products will be impacted by changes in regulation and classification.
- Patients receiving treatments involving HCT/Ps may be directly impacted by the safety and effectiveness of these therapies.
- Regulatory changes might impact the price and availability of such treatments, thereby indirectly affecting consumers and patients globally.
Reasoning
- The policy affects a specific sector of the population involved in the production, regulation, and use of human cells, tissues, and cellular and tissue-based products.
- The budget constraints suggest a focus on impactful yet cost-effective regulatory updates, which might primarily affect producers and direct users of these products.
- The common people affected are likely to be healthcare workers, patients using these therapies, and industry stakeholders. However, direct impact on the general populace would be limited.
- Given the policy's scope, impacts such as safety improvements, heightened regulatory compliance, and potential cost changes could affect user wellbeing.
- In assessing Cantril wellbeing scores, it is important to consider both direct beneficiaries (patients and healthcare providers) and indirect (industry and possibly future patients).
Simulated Interviews
Biomedical Researcher (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- I am anxious about the new compliance costs this policy might bring.
- The changes could slow down research approvals temporarily but may enhance safety.
- In the long run, standardizations are critical for patient safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 9 |
Patient (New York)
Age: 62 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Any policy that ensures safety is welcome since my health depends on quality treatments.
- However, there are concerns around cost increases for therapies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Regulatory Compliance Officer (Texas)
Age: 30 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 6/20
Statement of Opinion:
- Updating regulations means more responsibility but also clarity in compliance processes.
- It's stressful at first but ensures our products meet high safety standards.
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 | 7 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 8 |
Healthcare Provider (Florida)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Regulatory updates are crucial to ensure we provide safe and effective treatments to our patients.
- Initial adjustment might be hard, but it will enhance trust in the therapies we offer.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Community Health Advocate (Illinois)
Age: 28 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 8/20
Statement of Opinion:
- The policy may enhance patient trust in these therapies.
- It's important to balance regulation with accessibility to ensure everyone benefits.
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 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 9 |
Entrepreneur in Biotech (Massachusetts)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 3/20
Statement of Opinion:
- Updates on regulations can be both a challenge and an opportunity for innovation.
- Cost and time to comply need to be considered to ensure startups can thrive.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 8 |
Insurance Policy Analyst (Ohio)
Age: 55 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- Insurance policies need to adapt to ensure they cover safe and approved treatments.
- Regulatory changes might offer more clarity on what therapies are viable for coverage.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 9 | 9 |
Retired (Pennsylvania)
Age: 70 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- I support any measures to ensure the safety of transplants and therapies.
- However, I hope the policy doesn't lead to higher out-of-pocket costs.
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 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 8 | 7 |
Marketing Specialist in Health Sector (Georgia)
Age: 35 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 12/20
Statement of Opinion:
- Regulatory changes could make our communication campaigns more transparent.
- It is vital to adjust to ensure the target audience has confidence in our products.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 9 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Therapist (Oregon)
Age: 43 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 6.0 years
Commonness: 11/20
Statement of Opinion:
- I'm relieved knowing that new treatments are regulated for safety.
- Patients often ask about the legitimacy of therapies, so this update can be reassuring.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 9 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $20000000 (Low: $15000000, High: $25000000)
Year 3: $20000000 (Low: $15000000, High: $25000000)
Year 5: $0 (Low: $0, High: $0)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Regulatory changes may lead to temporary market disruptions as manufacturers adjust to new compliance requirements.
- Potential litigation costs or challenges could influence the implementation timeline of new regulations.
- Clarity in the definitions and processes might enhance sector confidence, potentially leading to new market entrants.