Bill Overview
Title: Accelerated Approval Transparency Act
Description: This bill requires the Food and Drug Administration to include a summary of the reasons a drug or biologic received accelerated approval to treat a serious or life-threatening disease or condition in the public action package for the drug or biologic.
Sponsors: Sen. Hickenlooper, John W. [D-CO]
Target Audience
Population: People needing treatment for serious or life-threatening conditions via accelerated approvals
Estimated Size: 1500000
- The bill pertains to drugs or biologics receiving accelerated approval, which are typically intended for serious or life-threatening diseases.
- The FDA's role in approving these drugs means it impacts populations in countries with similar regulatory approvals that consider FDA decisions, such as in parts of Europe or Canada.
- Accelerated approval often relates to treatments that address unmet medical needs, impacting individuals with specific, sometimes rare, conditions.
- Patients and healthcare providers will have access to more transparent information, affecting their decision-making processes.
- The global population affected includes all individuals potentially benefiting from or involved with these newly approved drugs.
Reasoning
- The Accelerated Approval Transparency Act will primarily affect patients with serious or life-threatening conditions, healthcare providers, and pharmaceutical companies.
- Patients in the U.S. who rely on drugs approved through accelerated processes will have more insight into the FDA's decision-making, potentially altering their perception of treatment efficacy and safety.
- Providers may use this transparency to guide clinical decision-making and discussions with patients.
- A small percentage of the general population is directly impacted; these represent situational niches (e.g., those awaiting potential treatments for rare diseases).
- Patients with better access to information may experience improved psychological wellbeing—control over their treatment options can reduce anxiety.
Simulated Interviews
Teacher (New York, NY)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I think having more information about why a drug received accelerated approval helps me understand my treatment options better.
- It would definitely make me feel more confident about the decisions being made for my health.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Retired engineer (Houston, TX)
Age: 68 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- The transparency will reassure me that the treatment I'm receiving was thoroughly considered by the FDA.
- Knowing more might help me in discussions with my doctor about alternative therapies.
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 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Biotech researcher (San Francisco, CA)
Age: 30 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- From a research perspective, more transparency may drive innovation by showing which areas have gotten approvals and why.
- It helps as a feedback loop for new drug development.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Cardiologist (Chicago, IL)
Age: 55 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 15.0 years
Commonness: 7/20
Statement of Opinion:
- This policy means I can better explain drug options to my patients, making informed decisions together.
- It will likely enhance trust in prescribed treatments for patients.
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 |
Patient advocate (Seattle, WA)
Age: 45 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- Increased transparency is a win for patient rights and makes advocating for patients easier.
- Hope it sets a precedent for more openness across the board.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Public health official (Miami, FL)
Age: 38 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- This is a good move towards enhancing FDA's credibility with the public.
- Could affect how public health campaigns communicate about drug safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Medical student (Boston, MA)
Age: 29 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 12/20
Statement of Opinion:
- This move is great for future doctors like me for understanding the criterias behind approvals.
- It enriches our learning and preparedness for patient advisory.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 6 |
Pharmaceutical executive (San Diego, CA)
Age: 60 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- It might increase regulatory scrutiny, but also adds value to our approval efforts with enhanced transparency.
- Essential for aligning company strategies with public expectations.
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 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Retired physician (Atlanta, GA)
Age: 75 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- For retired doctors still following medical developments, transparency brings added clarity and hope.
- Could guide recommendations when interacting with former patients or community members.
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 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Healthcare consultant (Philadelphia, PA)
Age: 40 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- This policy could streamline how hospitals internally discuss new treatment methods.
- More transparency means better policy alignment for health institutions.
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 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $5000000 (Low: $3000000, High: $7000000)
Year 2: $5000000 (Low: $3000000, High: $7000000)
Year 3: $5000000 (Low: $3000000, High: $7000000)
Year 5: $5000000 (Low: $3000000, High: $7000000)
Year 10: $5000000 (Low: $3000000, High: $7000000)
Year 100: $5000000 (Low: $3000000, High: $7000000)
Key Considerations
- The public availability of summary reasons for accelerated approvals could lead to greater scrutiny and confidence in FDA decisions.
- Compliance requires regular coordination with drug manufacturers and internal FDA stakeholders.
- Potential legal reviews or consultations might occur to ensure information released does not affect competitive confidentiality.
- Enhanced transparency could potentially increase public trust and FDA effectiveness in drug approvals.