Bill Overview
Title: Breakthrough Therapies Act
Description: This bill provides for the classification of drugs or other substances that are part of approved breakthrough therapies as schedule II controlled substances under the Controlled Substances Act. It also provides for expedited controlled substance registrations through the Drug Enforcement Administration for researchers whose work involves investigational drugs.
Sponsors: Sen. Booker, Cory A. [D-NJ]
Target Audience
Population: individuals involved with or affected by breakthrough therapies
Estimated Size: 157681600
- The bill affects researchers working with breakthrough therapies, requiring DEA registration for the substances involved.
- Patients who are part of clinical trials or receive treatment under breakthrough therapy designations may be affected as the substances are reclassified as schedule II controlled substances.
- The pharmaceutical companies that develop breakthrough therapies will be affected by the scheduling and any related legal compliance.
- Health care providers who prescribe breakthrough therapies may be impacted by the reclassification of these drugs, especially concerning prescribing practices and regulations.
- Schedule II classification will have implications for the distribution and security measures concerning these drugs.
Reasoning
- The budget limits indicate that the policy will need to be highly targeted, most directly affecting researchers and potentially large pharmaceutical companies. There might be indirect effects on patients through improved access to breakthrough therapies.
- The estimate of 157,681,600 Americans affected is high, but the direct and substantial impacts will likely be felt by smaller fractions within this broader group, such as researchers and those directly accessing the therapy.
- Distribution of funds needs to prioritise streamlined DEA processes, ensuring researchers and developers can adjust quickly to new scheduling requirements without significant administrative burden.
- The Cantril wellbeing scores will potentially vary considerably between those who are predominantly positively impacted, such as researchers gaining quicker access for studies, and those who might face stricter controls or regulatory hurdles.
Simulated Interviews
Pharmaceutical Researcher (Boston, MA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- The new classification provides a clear pathway for drug development, reducing some regulatory ambiguities.
- However, the schedule II classification adds layers of scrutiny and security requirements that could slow down parts of our work.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 9 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Oncologist (San Diego, CA)
Age: 68 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Scheduling as Schedule II could complicate trial access for patients, which is a downside.
- But expedited processes might help us move promising therapies through the pipeline faster—this would be beneficial.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 7 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 6 |
Clinical Trial Participant (Austin, TX)
Age: 30 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I'm hopeful the policy will make it easier for researchers to conduct trials more efficiently, which might help me and others in similar situations sooner.
- However, I'm concerned about the possible increased regulation which could limit access to treatment during trials.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 9 | 7 |
DEA Administrative Officer (Chicago, IL)
Age: 54 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- The policy will introduce more work initially as we adjust the scheduling, but should lead to clearer guidelines moving forward.
- Facilitated registrations will be useful for compliance and efficiency of operations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Pharmaceutical Regulations Consultant (New York, NY)
Age: 37 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 3/20
Statement of Opinion:
- A significant portion of my work involves helping companies align with regulations; this will streamline some processes and open new challenges, given the DEA's expediting clauses.
- Long-term, I see this as a net positive for innovative drug access in the U.S.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 6 |
Cancer Patient (Houston, TX)
Age: 64 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I'm hopeful that increased classifications and easier access for researchers will mean I get the cutting-edge treatments I need more quickly.
- On the downside, security and access issues could hinder some accessibility aspects.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 9 | 7 |
Biotech Company Executive (Seattle, WA)
Age: 42 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 2/20
Statement of Opinion:
- We expect streamlined DEA registrations will benefit our research timelines.
- However, reclassification as schedule II means higher obligations in security and monitoring, potentially increasing overhead costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
PhD Student in Biomedical Sciences (Denver, CO)
Age: 28 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Quicker access to controlled substances for research will accelerate my studies.
- There is potential worry about future career implications if further regulatory burdens become entrenched post changes.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Medical Journal Editor (Miami, FL)
Age: 55 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 6.0 years
Commonness: 3/20
Statement of Opinion:
- A more structured classification helps define the space within which articles can be written and understood by the public.
- New policies may inspire a range of ethical discussions that will need careful navigation and coverage.
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 | 5 |
| Year 20 | 6 | 5 |
Hospital Pharmacist (Raleigh, NC)
Age: 39 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 6.0 years
Commonness: 3/20
Statement of Opinion:
- More oversight on distribution will help ensure that potentially dangerous substances are monitored closely.
- However, scheduling as a schedule II could introduce delays in accessing these drugs for patient needs in acute cases.
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 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Cost Estimates
Year 1: $8000000 (Low: $5000000, High: $12000000)
Year 2: $8500000 (Low: $5500000, High: $12500000)
Year 3: $9000000 (Low: $6000000, High: $13000000)
Year 5: $10000000 (Low: $7000000, High: $14000000)
Year 10: $12000000 (Low: $9000000, High: $16000000)
Year 100: $80000000 (Low: $65000000, High: $95000000)
Key Considerations
- Reclassification as Schedule II may impose stricter controls, potentially affecting accessibility and distribution of breakthrough therapies.
- The DEA will need additional resources to handle expedited registrations and enforcement responsibilities.
- The pipeline for breakthrough drugs might be impacted positively, but the administrative workload could grow substantially.