Bill Overview
Title: Pre-approval Information Exchange Act of 2022
Description: This bill specifies that economic, scientific, or other product support information that is exchanged between drug manufacturers and health care entities (e.g., pharmacy benefit managers) about drug products before regulatory approval is not considered to be misbranding or prohibited premarket promotion 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: Individuals impacted by regulation of pre-approval drug information exchange
Estimated Size: 110000000
- The bill is related to drug information exchange prior to regulatory approval, specifically concerning investigational uses of drugs.
- Pharmaceutical companies and drug manufacturers are directly affected as their ability to share information is addressed by the bill.
- Healthcare entities such as pharmacy benefit managers are directly impacted since they are the recipients of pre-approval information.
- Researchers and scientists involved in drug development will be indirectly impacted as the flow of information can influence research directions and collaborations.
- Healthcare providers may be influenced by the information made accessible between these entities as it could affect future prescription practices.
- Patients, particularly those using investigational drugs, are indirectly impacted, as these processes could expedite access to or awareness of new treatments.
- The Government Accountability Office's study required by the bill may impact regulatory policies in the future, affecting all entities involved globally.
Reasoning
- Healthcare entities such as pharmacy benefit managers are significantly impacted as they will be recipients of the pre-approval information.
- Pharmaceutical companies and drug manufacturers are directly affected, as their information exchange practices will be influenced by the policy.
- Healthcare providers might indirectly experience impacts through changes in available drug information, potentially affecting prescribing practices.
- Researchers and scientists may be influenced as exchange of information could influence research paths and collaborations.
- Patients, especially those dealing with investigational drugs or treatments, might face changes in the timing or nature of treatment availability or information.
- The policy implementation is designed to bridge the gap before regulatory approval and might slightly expedite the introduction of therapies to the market.
Simulated Interviews
Pharmaceutical Research Scientist (Boston, MA)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- I believe the policy will be beneficial as it allows for a smoother exchange of vital drug information with healthcare entities.
- It may accelerate the speed at which we can move new drugs from trials into wider acceptance, which ultimately benefits patients.
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 | 8 | 8 |
| Year 20 | 7 | 7 |
Pharmacy Benefit Manager (Phoenix, AZ)
Age: 62 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The policy provides us with a better framework for understanding new drugs before they hit the market.
- This policy could reduce the lag time between approval and optimal formulary inclusion.
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 | 7 | 6 |
| Year 20 | 6 | 6 |
Primary Care Physician (San Francisco, CA)
Age: 35 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 10/20
Statement of Opinion:
- This policy might provide more clarity on potential treatments and new drug therapies.
- I am concerned about the potential pressure to prescribe investigational drugs prematurely.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Clinical Pharmacist (Chicago, IL)
Age: 28 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- This could help us provide better advice for patients who have limited options.
- I am concerned about the quality and reliability of pre-approved drug information.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Regulatory Affairs Specialist (New York, NY)
Age: 39 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 6/20
Statement of Opinion:
- It streamlines how drug entities can communicate investigational uses with us.
- I worry about the potential for increased pressure to approve hastily.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 5 | 5 |
Patient on experimental treatment (Miami, FL)
Age: 50 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Any policy that speeds up access to information on new treatments is a positive.
- I worry that the increased information might not always be in a format I can understand.
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 | 5 | 5 |
Biomedical Scientist (Denver, CO)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 5/20
Statement of Opinion:
- I'm thrilled that this policy might enhance collaborations and partnerships.
- I am curious about the impact this will have on regulatory processes long-term.
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 | 8 | 7 |
| Year 20 | 7 | 6 |
Bioethicist (Dallas, TX)
Age: 54 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy may challenge ethical considerations. Pre-market information sharing needs strong ethical guidelines.
- I support the intent but caution against potential misuse.
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 | 6 | 7 |
| Year 20 | 6 | 6 |
Nurse Practitioner (Seattle, WA)
Age: 41 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 8/20
Statement of Opinion:
- Increased early information might help us better prepare patients for potential new treatments.
- We must ensure this information doesn't confuse or mislead patients.
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 |
Regulatory Analyst (Atlanta, GA)
Age: 47 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 4/20
Statement of Opinion:
- The transparency it brings is necessary for progression, albeit with a risk of increased errors and pressure.
- It is a step forward for pre-approval processes although careful monitoring will be essential.
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 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 6 | 6 |
Cost Estimates
Year 1: $500000 (Low: $300000, High: $800000)
Year 2: $250000 (Low: $150000, High: $500000)
Year 3: $250000 (Low: $150000, High: $500000)
Year 5: $0 (Low: $0, High: $0)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- The level of compliance cost that will be absorbed by drug manufacturers and healthcare entities could indirectly influence market dynamics.
- The effectiveness and clarity of the criteria set for pre-approval information exchange may determine the success of the bill in practice.
- The GAO study may shape future regulatory policies in the pharmaceutical and healthcare information domains.
- The legal environment resulting from the bill could impact innovation incentives positively in the pharmaceutical industry.