Bill Overview
Title: SAFE Act of 2022
Description: This bill permanently places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. It limits the application of mandatory minimum penalties for certain offenses involving fentanyl-related substances, establishes a process to deschedule or remove certain fentanyl-related substances that have a low potential for abuse, and allows a federal court to vacate or reduce the sentence for convictions of offenses involving a fentanyl-related substance that is descheduled or moved to a schedule other than schedule I or II. The bill establishes a new, alternative registration process for schedule I research. It also makes other changes to registration requirements for conducting research with controlled substances, including permitting a single registration for related research sites in certain circumstances, waiving the requirement for a new inspection in certain situations, and allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration. Finally, the bill requires the Government Accountability Office to analyze the implementation and impact of permanently placing fentanyl-related substances into schedule I of the Controlled Substances Act.
Sponsors: Rep. Pappas, Chris [D-NH-1]
Target Audience
Population: Recreational opioid users impacted by fentanyl scheduling
Estimated Size: 4000000
- The legislation impacts those involved with fentanyl-related substances, either legally or illegally, due to the scheduling of the substance.
- Impact will be most direct on individuals using fentanyl recreationally, estimated at 27 million worldwide for opioids.
- Regulating Schedule I substances affects healthcare professionals, researchers, and pharmaceutical companies dealing in narcotics.
- Recreational opioid users span globally but are concentrated in regions with high opioid use issues like North America, Europe and parts of Asia.
- Considering global opioid use statistics, we can derive a rough estimate of individuals directly affected by tighter controls, excluding economic and indirect social impact.
Reasoning
- The interviews aim to represent a cross-section of impacted individuals, considering the diverse nature of the American populace regarding opioid use and interaction with research regulations.
- Given the policy's broad implications, perspectives from healthcare professionals, individuals affected by opioid addiction, and law enforcement are considered.
- We have included a diversity of locations, such as urban areas with notable opioid issues and rural areas where access to healthcare or substances may vary.
- The cost and program size limit considerations guide us to select individuals who illustrate a range of impacts from high to none, thereby ensuring scope for interventions that make a difference within the budget constraints.
- The policy aims to mitigate the opioid crisis while promoting safe research, so perspectives on research facilitation and barriers to accessing medical benefits are also included.
- Estimations of Cantril wellbeing scores consider the immediate effects of restricted substance access and long-term socioeconomic and health impacts.
Simulated Interviews
Unemployed (West Virginia)
Age: 32 | Gender: male
Wellbeing Before Policy: 3
Duration of Impact: 20.0 years
Commonness: 10/20
Statement of Opinion:
- This policy seems like it tries to address the root cause by limiting availability. However, it doesn't seem to tackle why people turn to substances in the first place.
- I worry it might make access to necessary treatment drugs more difficult due to stricter controls.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 2 | 3 |
| Year 2 | 3 | 4 |
| Year 3 | 4 | 4 |
| Year 5 | 5 | 5 |
| Year 10 | 5 | 6 |
| Year 20 | 6 | 6 |
Pain management specialist (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Any policy making research harder is concerning for us as doctors trying to find better pain management solutions.
- While the policy has positive intentions, it may increase barriers to finding better alternatives.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 7 | 8 |
| Year 20 | 7 | 8 |
PhD Researcher (New York)
Age: 29 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The changes in research protocols seem to offer more flexibility, which is beneficial for my work.
- Long term, this might improve our understanding and options for pain management.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Law enforcement officer (Ohio)
Age: 55 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This policy might help reduce illegal activity initially, but there's always a risk of people switching to alternatives.
- We need more community support systems as well.
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 | 5 | 4 |
| Year 10 | 6 | 5 |
| Year 20 | 7 | 5 |
Substance abuse counselor (Vermont)
Age: 38 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- Limiting fentanyl access is great, but we need more support networks and better rehabilitation services.
- I'm concerned about the lack of focus on preventative measures in the policy.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 4 |
Construction worker (Kentucky)
Age: 27 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- I see how this might reduce availability, but it won't stop people from finding something else.
- There's a need for better health supports along with policies like this.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 3 | 4 |
| Year 2 | 4 | 5 |
| Year 3 | 4 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 5 | 6 |
| Year 20 | 6 | 6 |
Retired (Texas)
Age: 62 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 12/20
Statement of Opinion:
- These controls might impact my access to medications for legitimate needs.
- It would be good to see more personalized approaches to such policies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Pharmaceutical researcher (Florida)
Age: 41 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The policy offers clearer regulations which can guide our research more effectively.
- Ensuring compliance will be important but challenging given budget constraints.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Social Worker (Illinois)
Age: 34 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- I see the need for these types of policies; however, addressing the social factors is just as crucial.
- Without more disease prevention and community resources, this could shift problems rather than solve them.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 7 | 5 |
Emergency room nurse (New Hampshire)
Age: 30 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 6/20
Statement of Opinion:
- If this reduces OD cases, that's excellent, but I'm cautious about how it'll play out in reality.
- Increased resources for prevention and treatment in hospitals are still needed.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 6 |
Cost Estimates
Year 1: $15000000 (Low: $10000000, High: $30000000)
Year 2: $15000000 (Low: $10000000, High: $30000000)
Year 3: $15000000 (Low: $10000000, High: $30000000)
Year 5: $15000000 (Low: $10000000, High: $30000000)
Year 10: $15000000 (Low: $10000000, High: $30000000)
Year 100: $15000000 (Low: $10000000, High: $30000000)
Key Considerations
- The potential for increased drug-related research due to relaxed research registration requirements.
- Shifts in criminal justice procedures due to changes in mandatory minimum sentencing.
- Long-term public health benefits from decreased availability and use of fentanyl.