Bill Overview
Title: Right to Try Clarification Act
Description: This bill specifies that investigational drugs that are provided directly to individuals from manufacturers without the need for federal regulatory approval (i.e., via the Right to Try pathway) are exempt from restrictions that would otherwise apply under the Controlled Substances Act (e.g., restrictions on the use or possession of schedule I controlled substances).
Sponsors: Sen. Booker, Cory A. [D-NJ]
Target Audience
Population: People with terminal illnesses seeking investigational treatments
Estimated Size: 500000
- The Right to Try legislation generally impacts individuals with terminal illnesses who want access to investigational drugs that haven't received full FDA approval.
- This clarification specifically concerns investigational drugs that may fall under the category of controlled substances under the Controlled Substances Act.
- Previously, such patients might have been legally barred from accessing experimental treatments if they included controlled substances, even if there was potential therapeutic benefit.
- The target population is sick patients who are seeking to try new investigational treatments that are regulated elsewhere.
- In the US, the Right to Try Act was signed into law in 2018, allowing terminally ill patients to access investigational treatments.
Reasoning
- The Right to Try Clarification Act primarily concerns a small, highly specific segment of the U.S. population—patients with terminal illnesses exploring investigational treatments, especially those involving substances otherwise controlled under federal law.
- Given the policy, the target demographic is mostly adults aged 35-85, reflecting the age distribution for terminal illness diagnoses, with cancers and neurodegenerative diseases being prominent.
- The budget restricts the program size to support service expansion and outreach efforts; this limits widespread impact and focuses on making a significant difference in the lives of those few who partake.
- We estimate that only a fraction of the terminally ill population will pursue Right to Try options due to varied barriers to awareness, access, and logistics, thus highlighting varying levels of impact across the population.
- Among those further enabled to try investigational drugs due to regulatory relaxation, emotional and mental wellbeing improvements might be anticipated, but quantification is sensitive to individual expectations and treatment viability. We aim to show a diverse narrative that includes unimpacted and impacted populations.
Simulated Interviews
Librarian (California)
Age: 54 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This Act feels like a glimmer of hope for people like me who are out of options.
- I'm worried about safety since these drugs are not fully approved, but the potential benefits outweigh the risks.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 3 |
| Year 5 | 5 | 2 |
| Year 10 | 4 | 1 |
| Year 20 | 2 | 0 |
Retired (Florida)
Age: 68 | Gender: male
Wellbeing Before Policy: 3
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- Finally, the chance to try new drugs provides hope, something that I haven't had since diagnosis.
- I wish this policy came earlier, but it's better late than never.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 3 |
| Year 2 | 5 | 3 |
| Year 3 | 5 | 2 |
| Year 5 | 4 | 1 |
| Year 10 | 3 | 0 |
| Year 20 | 1 | 0 |
Tech consultant (New York)
Age: 30 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- This act opens doors to experimental therapies that may slow disease progression.
- I'm excited about the possibility of contributing to research and potentially helping others with my condition.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 4 |
| Year 5 | 6 | 3 |
| Year 10 | 5 | 1 |
| Year 20 | 3 | 0 |
Teacher (Texas)
Age: 45 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 2.0 years
Commonness: 4/20
Statement of Opinion:
- I would consider trying anything that might give me more time with my children.
- I appreciate the policy but am still uncertain about accessibility.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 5 | 3 |
| Year 5 | 4 | 2 |
| Year 10 | 3 | 1 |
| Year 20 | 1 | 1 |
Retired engineer (Ohio)
Age: 72 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 2.0 years
Commonness: 5/20
Statement of Opinion:
- This feels like a win for our advocacy efforts, showing that steps can be taken to provide hope.
- While my situation remains unchanged, I'm relieved for my partner to have more options.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 4 |
| Year 5 | 5 | 3 |
| Year 10 | 4 | 2 |
| Year 20 | 2 | 1 |
Nurse (Washington)
Age: 60 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 4.0 years
Commonness: 3/20
Statement of Opinion:
- Opening up access to investigational drugs is necessary for those who feel every hope is lost.
- I'm personally interested, though cautious, about the availability and affordability.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 3 |
| Year 5 | 6 | 3 |
| Year 10 | 5 | 2 |
| Year 20 | 3 | 1 |
Freelancer (Illinois)
Age: 29 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 1.0 years
Commonness: 6/20
Statement of Opinion:
- This Act alone won't solve the wider issues of accessibility but it's a step forward.
- I remain hopeful, albeit skeptical, of how bodies like Congress will continue to support these moves.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 4 |
| Year 2 | 4 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 4 | 3 |
| Year 10 | 4 | 2 |
| Year 20 | 3 | 1 |
Retired school principal (Pennsylvania)
Age: 80 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 7/20
Statement of Opinion:
- It's about time restrictions are loosened for patients who are willing to take the risk.
- This provides psychological relief knowing there are more ways to manage the condition.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 4 |
| Year 10 | 5 | 3 |
| Year 20 | 3 | 2 |
Part-time writer (Colorado)
Age: 65 | Gender: other
Wellbeing Before Policy: 3
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy empowers people like me to have more control over their end-of-life care.
- It's reassuring to see movement that prioritizes patient autonomy.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 3 |
| Year 2 | 5 | 3 |
| Year 3 | 6 | 2 |
| Year 5 | 5 | 1 |
| Year 10 | 4 | 0 |
| Year 20 | 2 | 0 |
Home caregiver (New Jersey)
Age: 55 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 4.0 years
Commonness: 4/20
Statement of Opinion:
- With this policy, I see a chance to potentially prolong my life or improve its quality.
- I am caught between getting hopeful and being pragmatic about what this might realistically offer.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 6 | 3 |
| Year 10 | 5 | 2 |
| Year 20 | 3 | 1 |
Cost Estimates
Year 1: $1000000 (Low: $500000, High: $2000000)
Year 2: $1000000 (Low: $500000, High: $2000000)
Year 3: $1000000 (Low: $500000, High: $2000000)
Year 5: $1000000 (Low: $500000, High: $2000000)
Year 10: $1000000 (Low: $500000, High: $2000000)
Year 100: $1000000 (Low: $500000, High: $2000000)
Key Considerations
- The bill primarily impacts a specific patient group—the terminally ill seeking investigational treatments—limiting broader fiscal impacts.
- Administrative costs may increase slightly for oversight and enforcement organizations.
- A primary concern is ensuring proper measures are in place to manage investigational drug use safely.