Bill Overview
Title: Modern Authentication of Pharmaceuticals Act of 2022
Description: This bill requires each dose of a pharmaceutical product that is a controlled substance and that is taken orally in solid form (i.e., pills) to include a physical chemical identifier. The bill applies to products manufactured on or after January 1, 2026.
Sponsors: Rep. Mullin, Markwayne [R-OK-2]
Target Audience
Population: Users of controlled substance oral pharmaceuticals
Estimated Size: 100000000
- The bill applies to pharmaceuticals that are controlled substances and taken orally in solid form.
- Controlled substances have strict regulations and are often prescribed for pain management, mental health disorders, or addiction management.
- Pharmaceuticals are used worldwide and in the U.S., making the population potentially affected quite large.
- As of recent data, hundreds of millions globally use controlled substances for medical reasons.
Reasoning
- The policy targets users of controlled substances taken orally, specifically in solid form. These users often comprise patients managing chronic pain, mental health conditions, and addiction recovery.
- Given the significant budget, the policy is likely focused on large-scale implementation, potentially impacting up to 100 million Americans who use such medications.
- The inclusion of a physical chemical identifier aims to reduce the misuse and abuse of prescription drugs by enhancing traceability, which could influence wellbeing positively if it decreases addiction and overdose likelihood.
- Not everyone in the target population will be affected equally, as those with stable use and adherence to prescription guidelines might experience minimal change.
Simulated Interviews
Chronic Pain Patient (Los Angeles, CA)
Age: 45 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- The policy might mean stricter regulations and difficulty in obtaining medication.
- Safety measures are good but should not inconvenience patients in need.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Software Engineer (Austin, TX)
Age: 33 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 12/20
Statement of Opinion:
- I support measures to reduce drug abuse as long as it doesn't mean I'll have problems getting my medication.
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 |
Retired (Detroit, MI)
Age: 55 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- If the identifiers help reduce misuse, that's a good thing.
- I would be concerned if this impacts availability or cost.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 5 | 4 |
| Year 20 | 4 | 4 |
Nurse (Miami, FL)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 12/20
Statement of Opinion:
- I think safety measures are important but keep them straightforward for patients.
- My concern is with any additional cost.
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 |
Grandmother, Part-time librarian (Boston, MA)
Age: 62 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- Hope this policy prevents youthful misuse.
- Hope it doesn't complicate my own access.
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 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 5 | 6 |
Construction Worker (Seattle, WA)
Age: 40 | Gender: male
Wellbeing Before Policy: 3
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I see potential for this policy to help stop misuse.
- Any improvement that aids recovery processes is welcome.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 3 |
| Year 2 | 5 | 3 |
| Year 3 | 6 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 5 | 3 |
| Year 20 | 3 | 3 |
College Student (Newark, NJ)
Age: 21 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 14/20
Statement of Opinion:
- I think increasing drug accountability is important.
- I hope new measures don't burden my prescription process.
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 |
Retired Teacher (Phoenix, AZ)
Age: 71 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 0.0 years
Commonness: 6/20
Statement of Opinion:
- These measures might be very useful in preventing medication theft.
- Important that it doesn't interfere with critical medication.
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 |
Truck Driver (Houston, TX)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 15/20
Statement of Opinion:
- Policy introduces new tracking which is mostly positive for preventing misuse.
- I am wary of additional bureaucratic hurdles.
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 |
Product Manager (Chicago, IL)
Age: 37 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 13/20
Statement of Opinion:
- I am pro-healthcare safety, though method of implementation matters.
- Efficiency and ease of obtaining meds should be maintained.
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 |
Cost Estimates
Year 1: $2500000000 (Low: $2000000000, High: $3000000000)
Year 2: $2600000000 (Low: $2100000000, High: $3100000000)
Year 3: $2650000000 (Low: $2150000000, High: $3150000000)
Year 5: $2700000000 (Low: $2200000000, High: $3200000000)
Year 10: $2750000000 (Low: $2250000000, High: $3250000000)
Year 100: $2800000000 (Low: $2300000000, High: $3300000000)
Key Considerations
- The feasibility of developing and incorporating unique chemical identifiers in a cost-effective manner across all controlled substances.
- The readiness of pharmaceutical manufacturers to comply with new production standards by the 2026 deadline.