Bill Overview
Title: Pre-Approval Information Exchange Act of 2022
Description: This bill specifies that product information that is exchanged between drug manufacturers and certain health care entities (e.g., formulary committees) about drug products before regulatory approval is not considered to be misbranding if it relates to the product's investigational use and meets other specified criteria. The Government Accountability Office must study the use and effects of such information.
Sponsors: Rep. Guthrie, Brett [R-KY-2]
Target Audience
Population: Health care professionals, pharmaceutical employees, and related entities involved in drug approval and use processes
Estimated Size: 5000000
- The legislation affects how drug manufacturers and healthcare entities exchange information about investigational drug products before regulatory approval.
- Pharmaceutical companies or drug manufacturers will directly be impacted as it involves their investigational products and the exchange of this information.
- Healthcare entities, such as formulary committees and medical practitioners involved in drug approval and prescription processes, will also be impacted as they can receive investigational information earlier.
- Patients may indirectly be impacted as the potential acceleration in drug approval processes could alter the availability of new treatments.
- The Government Accountability Office (GAO) will have responsibilities associated with studying the use and effects of exchanged information, affecting their workload and priorities.
Reasoning
- The Act primarily impacts pharmaceutical companies, healthcare providers, and patients indirectly through its approach to drug approval and investigational information sharing.
- Pharmaceutical representatives will likely see improved processes with the ability to share investigational data earlier, possibly improving product development timelines.
- Healthcare professionals who serve on formulary committees will have access to more information that may affect their decision-making process, potentially impacting how quickly new drugs come to market.
- Patients may indirectly benefit from faster medication approval times as a broader range of treatment options becomes available more quickly.
- The policy budget aims to cover information exchange processes without overburdening the involved entities, supporting studies by the GAO to ensure accountability and effective implementation.
Simulated Interviews
Pharmaceutical Sales Representative (New Jersey)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- This policy gives us more leeway to communicate important information about investigational drugs.
- It should improve the transparency and speed of the drug approval process.
- It may help us by influencing positive formulary decisions.
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 |
Hospital Pharmacist (California)
Age: 35 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Getting information early means we can make more informed decisions for our patients.
- There's always a concern about the reliability of early-stage drug information.
- If managed well, this could streamline the access to new therapies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Retired Nurse (Florida)
Age: 60 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- I'm interested to see if this speeds up access to new medications.
- There might be safety concerns with sharing information too early.
- If it results in better drug access, that's a good thing.
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 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 7 | 5 |
General Physician (Texas)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 15/20
Statement of Opinion:
- This could help get new treatments to market faster for my patients.
- However, there's a chance of rushed decisions without proper reviews.
- My practice might be able to offer cutting-edge therapies sooner.
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 | 6 |
| Year 20 | 8 | 6 |
Research Scientist at a Biotech Firm (New York)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Early access to pre-approval information aligns our development strategies better.
- Concerns about potential pressure to market drugs prematurely remain.
- If handled carefully, this could be a win for both patients and developers.
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 |
Government Accountability Office Analyst (Illinois)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- Studying this policy's effect will be crucial for understanding its long-term benefits.
- Resource allocation will be a challenge given the complexity of the information exchange.
- It’s an important move for transparency and healthcare advancement.
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 | 8 | 6 |
| Year 20 | 8 | 6 |
Pharmacy Benefit Manager (Ohio)
Age: 55 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 5/20
Statement of Opinion:
- More information upfront could mean better pricing strategies.
- It opens up more refined decision-making windows for formularies.
- The true impact will hinge on how this information is interpreted and used.
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 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Clinical Trial Manager (Michigan)
Age: 33 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- This policy simplifies early discussions on drug effectiveness and safety.
- There might be increased pressure on trial outcomes and disclosures.
- Operational efficiency can improve if handled judiciously.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Regulatory Affairs Specialist (Massachusetts)
Age: 48 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 9/20
Statement of Opinion:
- The regulatory landscape might become dynamic with early information exchanges.
- There will be a need to adapt to fast-paced approval discussions.
- Clear gains are seen in potential approval timelines.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Health Policy Researcher (Alaska)
Age: 31 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 3/20
Statement of Opinion:
- It's a strategic move to enhance transparency in drug approval processes.
- However, long-term effects on access and pricing require further analysis.
- There's a key opportunity for improved communication on drug information.
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 |
Cost Estimates
Year 1: $21000000 (Low: $20000000, High: $22000000)
Year 2: $1000000 (Low: $500000, High: $1500000)
Year 3: $1000000 (Low: $500000, High: $1500000)
Year 5: $500000 (Low: $250000, High: $750000)
Year 10: $500000 (Low: $250000, High: $750000)
Year 100: $500000 (Low: $250000, High: $750000)
Key Considerations
- The accuracy and speed of the GAO study will be crucial to realizing potential long-term cost savings and efficiencies.
- The regulatory framework as established by this bill will require clear guidelines to ensure a robust but flexible information exchange process.
- Ensuring that patient safety is not compromised during the investigational information exchanges is critical.
- Potential backlash from parties opposed to loosening pre-approval information standards might require public and industry stakeholder management.