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: Sen. Kaine, Tim [D-VA]
Target Audience
Population: Individuals dependent on biologics for healthcare
Estimated Size: 20000000
- Biologics are a category of products that includes a wide range of medicines, such as vaccines, blood components, gene therapies, and recombinant therapeutic proteins.
- The primary individuals impacted are those who rely on biologic drugs for treatment, which can include patients with chronic diseases, cancer, autoimmune disorders, and rare genetic disorders.
- Global pharmaceutical companies must comply with regulations in varied markets, so patients worldwide may be indirectly impacted by increased transparency requirements.
- Healthcare providers, including doctors and pharmacists, will be better informed about the availability of biologics, affecting their ability to prescribe and dispense medications appropriately.
Reasoning
- Given the Biologics Market Transparency Act's focus on regulating the market by requiring manufacturers to notify the FDA before withdrawing products, the primary beneficiaries are patients who depend on biologic treatments. This can range from those with chronic illnesses to rare disease patients for whom alternatives might not exist.
- The aim of the policy is to prevent sudden shortages or withdrawal of critical biologic medicines, ensuring that healthcare providers can plan treatments better. This likely increases the patient's confidence and willingness to start or continue biologic treatments, potentially improving their long-term wellbeing.
- The policy will indirectly affect global markets as U.S.-based multinationals will align with new transparency regulations, setting a precedent internationally.
- Given the budgetary allocations, efforts will predominantly focus on regulatory compliance within the U.S., helping a substantial proportion of the estimated 20 million Americans dependent on biologics, prioritizing transparency and care continuity.
Simulated Interviews
Teacher (Austin, TX)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- I rely heavily on my biologic infusions to lead a normal life, so any policy that secures my access is vital.
- I've been anxious in the past about supply issues, and this might ease that worry.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Retired engineer (Seattle, WA)
Age: 60 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 5/20
Statement of Opinion:
- It's crucial that I'm informed about my medication supply, especially when it's so specific to managing my condition.
- This act gives me some peace of mind.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Marketing Director (New York, NY)
Age: 34 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 6/20
Statement of Opinion:
- Having transparency in availability helps in planning my cancer treatment schedule.
- Anything that keeps me informed about the availability of my treatment is welcome.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Pharmacist (Boise, ID)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 10/20
Statement of Opinion:
- As a pharmacist, knowing when a biologic is withdrawn helps me manage stock and inform patients.
- I expect overall stock management to improve with this transparency.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 6 | 6 |
Software Developer (Chicago, IL)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 15/20
Statement of Opinion:
- For someone with a condition that isn't life-threatening, ensuring access to my biologic is still key to maintaining my everyday quality of life.
- The policy ensures a level of safety net in drug availability.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Small Business Owner (Miami, FL)
Age: 42 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 6.0 years
Commonness: 8/20
Statement of Opinion:
- Injections are life-saving for me. Any guaranteed access over time is a stress reliever.
- Policy induced transparency makes my condition slightly less daunting.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Retired (Phoenix, AZ)
Age: 70 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Connecting with others in similar situations, I know many are anxious about drug availability.
- The policy indicates a positive move toward protecting people reliant on specific treatments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Healthcare Consultant (San Francisco, CA)
Age: 55 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 12/20
Statement of Opinion:
- A policy like this shapes better management of inventory and increases trust in biologic supply chains.
- Cautious optimism: execution is key to realizing these benefits.
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 | 7 | 7 |
| Year 20 | 7 | 7 |
Nurse (Boston, MA)
Age: 63 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 11/20
Statement of Opinion:
- We face challenges with biologic shortages, so anything that improves access would help.
- It's important that health professionals stay informed for effective patient care.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Graphic Designer (Los Angeles, CA)
Age: 39 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 8.0 years
Commonness: 5/20
Statement of Opinion:
- The policy looks like it could safeguard my treatment continuity.
- It's reassuring to have more assurance in biologic supply.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Cost Estimates
Year 1: $5000000 (Low: $3000000, High: $8000000)
Year 2: $5200000 (Low: $3100000, High: $8300000)
Year 3: $5400000 (Low: $3200000, High: $8600000)
Year 5: $5800000 (Low: $3400000, High: $9300000)
Year 10: $6500000 (Low: $3800000, High: $10400000)
Year 100: $10000000 (Low: $5800000, High: $16000000)
Key Considerations
- Biologics manufacturers will need to build systems for compliance, impacting administrative budgets slightly.
- FDA workload management will need adjustments to handle new monitoring responsibilities.
- Overall industry transparency could improve, potentially leading to long-term market stability.