Bill Overview
Title: Improving Access to Safe Medicines Act of 2022
Description: This bill requires the Drug Enforcement Administration to issue a proposed rule to remove a drug from scheduling under the Controlled Substances Act within 180 days of a recommendation from the Food and Drug Administration to do so.
Sponsors: Rep. Carter, Earl L. "Buddy" [R-GA-1]
Target Audience
Population: People using or in need of medications under the Controlled Substances Act
Estimated Size: 35000000
- The bill focuses on changing the scheduling of drugs under the Controlled Substances Act, which affects healthcare, pharmaceutical, and regulatory practices.
- Individuals who use medications currently classified under the Controlled Substances Act will be directly impacted as these drugs may become more accessible and easier to prescribe.
- Healthcare providers and pharmacists will be impacted as they will need to adjust practices based on changes in drug scheduling.
- The healthcare system at large may experience shifts in prescribing practices, resulting in changes in patient medication management.
- The DEA and other law enforcement agencies are involved in scheduling, and their operations and processes may change.
Reasoning
- The policy mainly affects individuals who are currently using drugs listed under the Controlled Substances Act and those who may benefit from drugs being rescheduled to allow for easier access and prescription.
- The impact on wellbeing will vary depending on how reliant individuals are on these medications for managing health conditions. Some may experience significant changes, while others might not feel the effects directly.
- Healthcare providers and pharmacists will face changes in prescribing and dispensing practices, potentially impacting their workloads and patient relationships.
- The DEA and FDA play critical roles in drug scheduling, and their operational changes may lead to broader implications for how drugs are accessed and prescribed across the U.S.
- Not every individual will be affected; hence mixed impacts on wellbeing are expected, with some positive changes for those needing increased access while others may not notice any change.
Simulated Interviews
Pharmacist (Phoenix, AZ)
Age: 54 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- I'm hopeful that this change will make it easier for patients to receive necessary medications without as many bureaucratic hurdles.
- There could be challenges initially adjusting to the new rules, but it might streamline operations in the long run.
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 | 9 | 7 |
| Year 20 | 9 | 7 |
Chronic pain patient (Charleston, WV)
Age: 45 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- If this policy means I can get my medication without so much stigma and hassle, it would improve my quality of life.
- I'm worried that changes might actually restrict access further if misunderstood.
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 |
Healthcare Policy Analyst (Boston, MA)
Age: 30 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- This initiative aligns with efforts to modernize drug policy and access to necessary medications.
- The challenge will be maintaining a balance between access and control.
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 |
DEA Regulatory Officer (Columbus, OH)
Age: 62 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- I worry that too rapid rescheduling without proper controls could lead to misuse and enforcement challenges.
- We need time to adapt our procedures to these new changes.
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 | 6 | 6 |
Primary Care Physician (New York, NY)
Age: 50 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This policy might simplify some of the red tape we deal with when prescribing medication, benefiting both patients and providers.
- I'm cautiously optimistic but worry about unintended consequences like increased scrutiny.
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 |
Patient with anxiety disorder (Dallas, TX)
Age: 36 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- If rescheduling helps reduce stigma and makes access easier, my life quality would improve.
- I'm concerned that policy changes could initially confuse both patients and providers.
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 |
Veteran with PTSD (Portland, OR)
Age: 40 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- Making these medications easier to access could really help me manage my symptoms better and live a fuller life.
- Consistency in supply would improve if these scheduling hurdles were reduced.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 9 | 5 |
Startup founder, digital health (San Francisco, CA)
Age: 28 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- Changes in drug scheduling could open new markets for digital health solutions aimed at medication management.
- The policy might drive innovation as medication access improves.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Retired teacher (Madison, WI)
Age: 65 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I'm optimistic that easier access will improve my life but worried about the possibility of these drugs being misused.
- There needs to be a balance between the accessibility of my medications and safeguarding against abuse.
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 |
Pharmaceutical researcher (Chicago, IL)
Age: 34 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy could potentially streamline the process of bringing effective medications to the market.
- As a researcher, rescheduling might enhance the feasibility of studying certain compounds.
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 | 9 | 8 |
Cost Estimates
Year 1: $10000000 (Low: $8000000, High: $15000000)
Year 2: $10000000 (Low: $8000000, High: $15000000)
Year 3: $10000000 (Low: $8000000, High: $15000000)
Year 5: $10000000 (Low: $8000000, High: $15000000)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- The speed of regulatory processes at the DEA following FDA recommendations can vary, affecting cost estimates.
- Potential changes in healthcare practices and public perception regarding accessibility to previously controlled substances.
- Potential legal challenges or resistance from stakeholders may alter implementation timelines and associated costs.