Bill Overview
Title: ADAPT 2.0 Act
Description: This bill allows applicants seeking Food and Drug Administration (FDA) approval to market a new drug to rely on investigations conducted in certain other countries and addresses related issues. If an applicant seeks market approval for a new drug with an application that relies on at least one investigation that the applicant did not conduct and did not obtain approval to use, the applicant may rely on an investigation that was conducted in certain foreign countries if the drug in question has already been approved in that country. The investigation must have been conducted in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the United Kingdom, the European Union, a country in the European Economic Area, or another country that the FDA has found to meet certain requirements. The FDA must make a decision on such an application within 90 days of the application's filing. If the FDA does not take certain actions within that period, the application shall be considered approved. The FDA may require the applicant to conduct postapproval studies of the drug and to submit copies of all promotional materials. The bill also establishes an advisory committee to provide the FDA with recommendations as to each application that relies on a foreign investigation. The FDA must make available on its public website each decision on such an application, including the rationale for the decision and the advisory committee's recommendations.
Sponsors: Sen. Braun, Mike [R-IN]
Target Audience
Population: People who may seek or require medical treatments
Estimated Size: 330000000
- The bill impacts drug manufacturers by potentially shortening the time and cost to bring new drugs to the U.S. market.
- Patients seeking new or innovative treatments may have faster access to drugs approved in other developed countries.
- Healthcare providers might have more treatment options available more quickly.
- By aligning with drug approvals in other countries, it could influence global pharmaceutical markets and regulations.
Reasoning
- The policy could lead to faster drug availability by streamlining the approval process in the US when drugs are already vetted in other countries. However, this might raise concerns about the thoroughness of approvals and the reliance on external drug trials.
- It potentially benefits patients with urgent medical needs or with conditions that have fewer treatment options, as it could provide faster access to innovative drugs.
- The impact may vary widely depending on whether individuals are directly affected by the drugs likely to be accelerated through this process, which might not be a large segment of the overall population.
- Budget considerations will primarily affect regulatory processes within the FDA and the pharmaceutical companies seeking the benefits of expedited approvals.
- The wellbeing of those directly affected could improve due to earlier access to potentially life-saving or life-improving medication. However, for the broader population not immediately affected by the specific drugs fast-tracked, the impact could be neutral or even slightly negative due to concerns over safety and regulation stringency.
Simulated Interviews
Patient Advocate (New York, NY)
Age: 34 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- I believe the ADAPT 2.0 Act could significantly improve lives by making drugs available sooner.
- However, I worry about the safety if the FDA relies too heavily on foreign studies without additional oversight.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Pharmaceutical Executive (Dallas, TX)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- This bill could streamline the path to market for innovative therapies, allowing us to bring treatments to patients who need them faster.
- It will also significantly reduce costs for companies like ours.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
Retired Nurse (Seattle, WA)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- While quick access to medications is important, I am concerned about the safety implications of relying on foreign data.
- I think there needs to be a balance between speed and safety.
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 |
Medical Doctor (Miami, FL)
Age: 42 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 4/20
Statement of Opinion:
- For my patients with rare conditions, having more treatment options sooner could be incredibly beneficial.
- The risk is that without thorough domestic investigations, we could see unforeseen side effects.
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 | 8 | 7 |
Technology Consultant (Austin, TX)
Age: 29 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 14/20
Statement of Opinion:
- This policy doesn't directly affect me, as I don't rely on medications that aren't already approved.
- However, I'd prefer a cautious approach to drug approval.
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 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Health Policy Expert (Los Angeles, CA)
Age: 60 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The ADAPT 2.0 Act can reduce bureaucracy and make critical drugs available.
- Still, the FDA must maintain rigorous oversight to ensure 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 |
Academic Researcher (Chicago, IL)
Age: 44 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Aligning our drug regulations with global standards could benefit both the US and other countries.
- It's crucial that foreign studies meet our standards to prevent safety compromises.
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 | 7 | 6 |
| Year 20 | 7 | 6 |
Cancer Survivor (Phoenix, AZ)
Age: 52 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Faster access to drugs could provide hope to many patients waiting for new treatments.
- There needs to be careful regulation to protect us from harmful consequences.
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 | 7 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Government Healthcare Worker (Detroit, MI)
Age: 39 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- This policy might reduce costs in public health by providing cheaper access to imported medications.
- However, it could strain regulatory resources if oversight is not scaled proportionately.
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 |
Consumer Advocate (San Francisco, CA)
Age: 47 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Making drugs available quicker is a positive step, but it should not compromise transparency in approval processes.
- Patients need clear information about how drugs are approved and their potential risks.
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 |
Cost Estimates
Year 1: $75000000 (Low: $50000000, High: $100000000)
Year 2: $77000000 (Low: $51000000, High: $102000000)
Year 3: $79000000 (Low: $52000000, High: $104000000)
Year 5: $81000000 (Low: $53000000, High: $106000000)
Year 10: $85000000 (Low: $56000000, High: $110000000)
Year 100: $100000000 (Low: $60000000, High: $150000000)
Key Considerations
- Implementation of the bill requires careful monitoring to ensure foreign-investigated drugs meet U.S. safety standards.
- Potential changes in international relations and pharmaceutical markets due to reliance on foreign investigation approvals.
- Ensuring the expedited review process is robust and does not compromise patient safety.