Bill Overview
Title: Protecting Americans from Unsafe Drugs Act of 2022
Description: This bill expands the authority of the Secretary of the Department of Health and Human Services (HHS) to order the recall of controlled substances to cover all drugs. Furthermore, the authority to issue such an order may be delegated to the Director of the Center for Drug Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or an official senior to either director), whereas currently this authority may only be delegated to the Director of the Center for Drug Evaluation and Research or an official senior to such director. (Both centers are located in the Food and Drug Administration within HHS.)
Sponsors: Rep. Kim, Andy [D-NJ-3]
Target Audience
Population: Individuals using pharmaceutical drugs globally
Estimated Size: 219000000
- The bill expands recall authority to cover all drugs, which signifies that any person using medication could potentially be impacted.
- The global pharmaceutical market affects people worldwide, not only in the U.S, thus potentially impacting anyone with access to pharmaceuticals.
- Since the U.S. is a major market for pharmaceuticals and many drugs are approved by the FDA, changes in FDA policy may have international ramifications.
Reasoning
- Given the budget constraints, the policy would initially focus on the most critical drugs that pose significant health risks, thereby limiting the number of drug recalls that can be funded and implemented in the first year.
- Role segmentation allows for specialized oversight in drug recalls, which can increase efficiency but requires staff training and collaboration among FDA departments.
- The policy impacts those taking prescription and over-the-counter drugs, but people using more common/generic drugs may be more affected due to greater market penetration and less stringent oversight previously.
- The wellbeing improvements or declines largely depend on the extent to which current drugs are found unsafe and the effectiveness of the recall system.
Simulated Interviews
Pharmacist (New York City, NY)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- It's great to have more authority to recall unsafe drugs, but it might initially slow down the availability of medications while evaluations are pending.
- Patients may become anxious if drugs they depend on are suddenly recalled, impacting trust and willingness to start new medications.
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 | 8 | 7 |
| Year 20 | 8 | 7 |
Retiree (Chicago, IL)
Age: 60 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- The policy gives me peace of mind knowing there's more scrutiny on drug safety.
- However, if any of my medications are recalled, the transition could be difficult and costly.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
Software Developer (Austin, TX)
Age: 42 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 10/20
Statement of Opinion:
- This policy doesn’t seem to affect me much as I rarely take medication.
- It's still reassuring to know there's a system to catch unsafe drugs early on.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Influencer (Los Angeles, CA)
Age: 28 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 4/20
Statement of Opinion:
- I'm concerned the policy might limit my access to some supplements or alternative health products if they fall under greater scrutiny.
- However, it might protect consumers from unsafe, unregulated products.
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 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
High School Teacher (Miami, FL)
Age: 50 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 8.0 years
Commonness: 7/20
Statement of Opinion:
- I'm worried that if a drug I'm on is recalled, it could worsen my condition or complicate management strategies.
- More protective measures are needed, though especially for chronic illness medications.
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 | 5 |
Farmer (Rural Ohio)
Age: 38 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 1.0 years
Commonness: 5/20
Statement of Opinion:
- The policy doesn’t seem to impact allergy medications much, but I see value in the potential for increased safety.
- It could, however, result in supply chain issues leading to temporary shortages.
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 | 6 | 6 |
| Year 20 | 6 | 6 |
Retired Engineer (Seattle, WA)
Age: 65 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- I'm supportive of stricter measures for drug recalls, as it aligns with ensuring public safety.
- However, I hope it doesn’t result in frequent recalls without reasonable cause.
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 | 7 | 5 |
| Year 20 | 7 | 5 |
Nurse (Denver, CO)
Age: 40 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 6/20
Statement of Opinion:
- Increased authority might lead to improved safety protocols, which is great for patient care.
- Such policies need proper communication channels to avoid misinformation and panic.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Retired Veteran (Phoenix, AZ)
Age: 77 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 7.0 years
Commonness: 4/20
Statement of Opinion:
- Policies like this make me worry more about the availability and safety of my medication.
- Access to safe drugs should be a priority, but the changes should not delay important treatments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 7 | 4 |
Graduate Student (San Francisco, CA)
Age: 26 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 7/20
Statement of Opinion:
- This policy might influence my future work, emphasizing more stringent regulations and safety checks.
- I feel positively about the change if it can prevent future crises in drug safety.
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: $75000000 (Low: $50000000, High: $100000000)
Year 2: $77000000 (Low: $52000000, High: $103000000)
Year 3: $79000000 (Low: $54000000, High: $106000000)
Year 5: $83000000 (Low: $57000000, High: $111000000)
Year 10: $90000000 (Low: $62000000, High: $120000000)
Year 100: $150000000 (Low: $120000000, High: $180000000)
Key Considerations
- The bill substantially changes the authority structure within the FDA, affecting how drug recalls are managed.
- Implementing this change requires significant retraining and administrative overhaul.
- Ongoing oversight costs may be high due to broader scope of drug monitoring.