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: Rep. Blumenauer, Earl [D-OR-3]
Target Audience
Population: individuals seeking investigational drugs under Right to Try pathways
Estimated Size: 700000
- The global population includes everyone who may seek investigational drugs via the Right to Try pathway, possibly because they have life-threatening conditions for which current treatments are ineffective.
- The Right to Try legislation is particularly relevant in jurisdictions where federal regulatory processes can significantly delay access to investigational drugs. This generally applies most directly to the United States, which has clearly defined federal pathways for drug approval.
- The impact is predominantly on patients and individuals with severe, potentially terminal conditions who have no other treatment options and are willing to try investigational drugs.
- The exemption of these investigational drugs from Schedule I controlled substances restrictions broadens the range of investigational drugs that might be accessed under the Right to Try pathway.
- Global access to investigational drugs varies, and the Right to Try pathway is a legislative framework that is specific to the United States.
Reasoning
- The majority of individuals affected by this policy will be those with terminal illnesses or conditions that are currently not well-managed by existing treatments.
- The cost limitations mean that the policy's implementation needs to be targeted and efficient, possibly prioritizing those most in need or most likely to benefit from such treatments.
- The diversity of the target population includes different age groups, various stages of illnesses, geographic differences, and socioeconomic variations which can affect both access to information and healthcare resources.
- Given the Right to Try pathway primarily affects terminally ill patients, its impact might be most visible in the initial years after implementation, with fewer long-term effects as patients either find effective treatments or transition to palliative care options.
- The incorporation of Schedule I controlled substances into the Right to Try pathway might increase demand and requests for investigational drugs, which necessitates proper management and ethical considerations.
Simulated Interviews
Retired Air Force Pilot (Texas)
Age: 56 | Gender: male
Wellbeing Before Policy: 3
Duration of Impact: 3.0 years
Commonness: 3/20
Statement of Opinion:
- I want to try any drug that might give me more time or better quality of life.
- It's frustrating that bureaucracy can stand in the way during such desperate times.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 3 |
| Year 2 | 6 | 3 |
| Year 3 | 5 | 3 |
| Year 5 | 3 | 2 |
| Year 10 | 3 | 2 |
| Year 20 | 2 | 1 |
Graphic Designer (California)
Age: 42 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Having access to these drugs without the usual delays could be life-changing.
- Even if the treatment is not successful, it offers hope and a sense of control.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 5 | 4 |
| Year 5 | 4 | 3 |
| Year 10 | 3 | 2 |
| Year 20 | 2 | 1 |
Research Scientist (New York)
Age: 29 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- Being able to access investigational drugs more freely is crucial for advancing treatments.
- There should be more awareness about such pathways to simplify patient decisions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 3 |
| Year 10 | 5 | 2 |
| Year 20 | 4 | 1 |
Retired Engineer (Florida)
Age: 65 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 5/20
Statement of Opinion:
- The policy seems promising, though I'm cautious about using controlled substances.
- Hope this doesn't mean cutting corners on safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 4 |
| Year 20 | 4 | 3 |
Nurse (Minnesota)
Age: 37 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 6.0 years
Commonness: 4/20
Statement of Opinion:
- I see the benefit for people like my husband who might try an investigational drug.
- It's important to maintain a balance between access and safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 3 |
| Year 3 | 5 | 3 |
| Year 5 | 4 | 2 |
| Year 10 | 3 | 2 |
| Year 20 | 2 | 1 |
Small Business Owner (Alabama)
Age: 50 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- This policy might prevent tragedies similar to what my family went through.
- Ensuring access to experimental treatments is a must for those with rare diseases.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 4 |
| Year 5 | 5 | 3 |
| Year 10 | 5 | 3 |
| Year 20 | 5 | 2 |
Doctor (Illinois)
Age: 60 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This might alleviate some frustrations in the treatment process.
- Concerns about misuse still need to be addressed.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 5 | 5 |
| Year 20 | 4 | 4 |
Retired Teacher (Maine)
Age: 72 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 7.0 years
Commonness: 5/20
Statement of Opinion:
- More choices can only be a good thing, especially at my age.
- Accessibility can be a major issue, not everyone knows such options exist.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 3 |
| Year 3 | 5 | 3 |
| Year 5 | 4 | 2 |
| Year 10 | 3 | 2 |
| Year 20 | 2 | 1 |
Graduate Student (Washington)
Age: 25 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 10/20
Statement of Opinion:
- It's a fine line to walk between speeding up drug access and ensuring they're safe.
- Patients should always have informed consent when trying new medications.
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 |
College Student (Ohio)
Age: 20 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 2.0 years
Commonness: 7/20
Statement of Opinion:
- It's intriguing to think some drugs could become more accessible.
- I do worry about potential harm versus benefit with less oversight.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 4 | 4 |
| Year 20 | 4 | 3 |
Cost Estimates
Year 1: $30000000 (Low: $20000000, High: $40000000)
Year 2: $31000000 (Low: $21000000, High: $41000000)
Year 3: $32000000 (Low: $22000000, High: $42000000)
Year 5: $35000000 (Low: $25000000, High: $45000000)
Year 10: $40000000 (Low: $30000000, High: $50000000)
Year 100: $100000000 (Low: $80000000, High: $120000000)
Key Considerations
- Monitoring of patients who use investigational drugs without federal approval could lead to additional administrative costs.
- The impact on insurance systems, as it may affect both coverage and premiums if these investigational drug treatments show efficacy.
- Potential legal and ethical considerations in the handling of Schedule I substances under the pathway.