Bill Overview
Title: Recall Unsafe Drugs Act of 2022
Description: This bill authorizes the Food and Drug Administration (FDA) to order the recall of certain adulterated or misbranded drugs and contains other related provisions. A producer of a medication must notify the FDA of the identity and location of a drug if the producer has reason to believe that (1) the drug is adulterated or misbranded, and (2) there is a reasonable probability that the drug will cause a threat of serious adverse health consequences or death to humans or animals. If use of a drug may cause serious adverse health consequences or death, the FDA may order the producer to immediately cease distribution and notify affected individuals. After issuing such an order, the FDA may also order a recall after affording the producer an opportunity for an informal hearing. If a drug presents an imminent threat of serious adverse health consequences or death, the FDA may order the producer to immediately recall the drug and notify affected individuals. The distributor may appeal such an order. An individual or entity required to register as a producer of drugs or medical devices must have a recall plan in effect.
Sponsors: Rep. DeLauro, Rosa L. [D-CT-3]
Target Audience
Population: Consumers of pharmaceutical drugs worldwide
Estimated Size: 250000000
- The legislation targets drugs that are adulterated or misbranded, which could potentially affect all individuals consuming prescription or over-the-counter medications globally.
- The act involves the FDA, which primarily regulates the drug market in the United States, but recalls can affect drugs manufactured globally.
- Global pharmaceutical companies and distributors who distribute drugs that might be deemed unsafe are directly impacted.
- Secondary impact may also be felt by healthcare providers and patients who depend on these medications.
Reasoning
- The policy mostly affects individuals who consume prescription or over-the-counter drugs, which is a major portion of the U.S. population.
- We need to include a mix of people who are directly impacted by potentially unsafe drugs and those who are not affected.
- The impact is primarily on health and wellbeing, but financial implications may also affect healthcare costs.
- The target population is large (250M Americans), so we'll see diverse impacts from none to high.
Simulated Interviews
Pharmacist (New York, NY)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- I think this policy will be beneficial in ensuring the safety of drugs our customers use.
- The formal recall process by the FDA provides clarity and security.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Retired (Los Angeles, CA)
Age: 58 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I am relieved that there will be more oversight on the drugs I take.
- This policy gives me peace of mind regarding drug safety.
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 | 7 | 5 |
| Year 20 | 6 | 5 |
Healthcare Consultant (Austin, TX)
Age: 42 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- This policy helps ensure better practices in the pharmaceutical industry.
- It aligns with other regulatory standards globally.
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 | 10 | 7 |
Software Engineer (Seattle, WA)
Age: 31 | Gender: male
Wellbeing Before Policy: 9
Duration of Impact: 0.0 years
Commonness: 12/20
Statement of Opinion:
- I don't expect this policy to affect me personally.
- It's good for those who need medications but not really relevant to me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 9 |
| Year 3 | 9 | 9 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Graduate Student (Chicago, IL)
Age: 29 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 10/20
Statement of Opinion:
- This policy is a step forward for public health.
- It provides a necessary layer of safety for all drug consumers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Pharmaceutical Sales Representative (Miami, FL)
Age: 45 | Gender: male
Wellbeing Before Policy: 9
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- There might be increased operational requirements but overall it's good for industry standards.
- Patient safety should be a priority.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 9 |
| Year 2 | 8 | 9 |
| Year 3 | 8 | 9 |
| Year 5 | 7 | 8 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Patient Advocate (Portland, OR)
Age: 25 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- I'm really pleased to see a policy that adds more safety for patients.
- The fewer unsafe drugs available, the better for everyone's wellbeing.
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 | 8 | 5 |
| Year 20 | 7 | 5 |
Chemist (Houston, TX)
Age: 33 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- The Recall Unsafe Drugs Act will drive improvements in safety standards.
- It's important for protecting public health from potentially dangerous drugs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Chronic Illness Patient (Detroit, MI)
Age: 62 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- It's crucial for me that drugs are safe and reliable, this policy helps.
- I'm glad there's more oversight on the drugs I need every day.
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 | 6 | 4 |
| Year 20 | 5 | 4 |
Small Business Owner (Atlanta, GA)
Age: 40 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 11/20
Statement of Opinion:
- While it might affect some of the products I sell, it's worth it for customer safety.
- I'm supportive of policies enhancing drug safety.
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 | 6 |
Cost Estimates
Year 1: $50000000 (Low: $40000000, High: $60000000)
Year 2: $51000000 (Low: $41000000, High: $61000000)
Year 3: $52020000 (Low: $42000000, High: $62040000)
Year 5: $54080000 (Low: $44000000, High: $64160000)
Year 10: $58580000 (Low: $48000000, High: $69480000)
Year 100: $200000000 (Low: $160000000, High: $240000000)
Key Considerations
- Costs for setting up robust recall systems and procedures.
- Potential savings from reduced healthcare expenditures on treating adverse drug reactions.
- Impact on the pharmaceutical industry's operational and legal compliance costs.
- Initial economic disruption versus long-term health benefits.