Bill Overview
Title: Biologics Market Transparency Act of 2022
Description: This bill requires biologics manufacturers to notify the Food and Drug Administration in advance of withdrawing a product from sale.
Sponsors: Rep. Manning, Kathy E. [D-NC-6]
Target Audience
Population: People relying on biologic treatments
Estimated Size: 30000000
- Biologics are medical products derived from biological sources used to treat various medical conditions, affecting a large number of patients.
- The requirement to notify the FDA before withdrawing a product ensures continuity of treatment or timely transition to alternatives, hence impacting patients relying on biologic treatments.
- Healthcare providers will be indirectly impacted as they must accommodate any changes in biologic product availability that might affect treatment plans.
- Regulatory bodies like the FDA, tasked with overseeing drug availability and market dynamics, will also be operationally affected due to increased communication with biologics manufacturers.
- The pharmaceutical industry, focused on biologics, would be impacted as manufacturers must comply with additional regulatory requirements.
- Caregivers and families of patients who use biologics may also experience an impact as any change in treatment can affect the patient's health and wellbeing.
Reasoning
- The Biologics Market Transparency Act of 2022 affects a variety of individuals, from patients relying on biologic treatments to healthcare providers, regulatory bodies, and biologics manufacturers. The policy's main impact will be ensuring continuity of treatment for patients and enabling the FDA to manage the market dynamics efficiently. Given the high cost of biologics and the relatively limited budget spread over ten years, the policy initially might only cover notification processes rather than more extensive measures like subsidies or insurance reform.
- The target population mostly includes patients with chronic conditions using biologic treatments and healthcare providers who must adapt to any changes in treatment availability. Patients' wellbeing primarily revolves around uninterrupted access to these treatments, which can significantly affect their quality of life.
- Caregivers and families of patients are indirectly influenced since any disruptions in treatment can have significant personal and economic repercussions.
- The regulatory perspective includes additional administrative duties handled by the FDA, which aligns with the budget designated for managing communications and compliance checks.
- Finally, since the pharmaceutical companies need to understand and implement new compliance measures, they slightly contribute to the population impacted by this policy.
Simulated Interviews
Nurse (Chicago, IL)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- The policy seems useful for patient care, ensuring that we're informed about biologics withdrawals in advance.
- This can help us plan alternative treatments without interrupting patient care.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Pharmaceutical Project Manager (Austin, TX)
Age: 35 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 8/20
Statement of Opinion:
- The new requirement might increase workload and operational costs, but it's critical for patient safety.
- Overall, it's manageable and helps maintain trust with healthcare providers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Patient (New York, NY)
Age: 60 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- Knowing in advance about any potential discontinuation of my medication is reassuring.
- This policy reduces my anxiety about the stability of my treatment.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Biotech CEO (San Francisco, CA)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- The policy might cause minor logistical issues, but it ensures a stable market.
- Improved communication with the FDA can guide better business strategies in the long term.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Caregiver (Seattle, WA)
Age: 28 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 12/20
Statement of Opinion:
- This policy provides peace of mind knowing we won't be caught off guard if a medication is pulled.
- It's one less thing to worry about.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
FDA Regulatory Officer (Atlanta, GA)
Age: 40 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- The additional notifications can streamline our oversight tasks, improving public health safety.
- Overall, it better aligns our resources with industry practices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Healthcare Policy Analyst (Denver, CO)
Age: 33 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- The Biologics Market Transparency Act aligns with current trends in precision medicine, enhancing oversight.
- It's a balanced policy for ensuring patient access and managing market dynamics.
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 |
Oncologist (Miami, FL)
Age: 42 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 9/20
Statement of Opinion:
- Advanced notification of biologics withdrawal can significantly aid in arranging alternative treatment plans.
- This policy reduces clinical disruptions.
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 | 8 | 6 |
Retired Teacher (Phoenix, AZ)
Age: 70 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- Having the assurance that my medication will remain available is comforting.
- The policy allows planning ahead and adjusting if necessary.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 4 |
Grad Student (Portland, OR)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- The Act represents a step toward transparency and better market stability.
- Useful for someone debating whether to enter pharmaceuticals or regulatory work.
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 | 7 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $20000000 (Low: $15000000, High: $25000000)
Year 2: $18000000 (Low: $13000000, High: $23000000)
Year 3: $16000000 (Low: $11000000, High: $21000000)
Year 5: $15000000 (Low: $10000000, High: $20000000)
Year 10: $12000000 (Low: $8000000, High: $16000000)
Year 100: $5000000 (Low: $3000000, High: $7000000)
Key Considerations
- Behavior changes in biologics manufacturers due to the compliance requirement of notifying withdrawals.
- FDA’s capability and resource allocation to manage new regulatory demands.
- Potential for enhancing patient trust in biologic treatments, reducing healthcare disruptions.
- The effect on market dynamics and competitive behavior among biologics manufacturers.