Bill Overview
Title: Increase Access to COVID Testing Act
Description: This bill directs the Food and Drug Administration (FDA) to provide upon request emergency use authorization for COVID-19 rapid antigen tests approved for use in the European Union. During the declared COVID-19 public health emergency, the FDA shall grant emergency use authorization to a COVID-19 rapid antigen test upon a proper request by the test's manufacturer if (1) the test is on the European Commission Directorate-General for Health and Food Safety's common list for approved COVID-19 tests, and (2) the request is for the non-laboratory use of the test without a prescription. The bill waives certain requirements for a request for emergency use authorization under this bill, such as a finding from the FDA that the test may be effective in diagnosing COVID-19. If a test authorized under this bill is removed from the EU common list, the FDA must determine within 30 days of such removal whether the emergency use authorization for the test should continue.
Sponsors: Sen. Sasse, Ben [R-NE]
Target Audience
Population: People requiring or benefiting from COVID-19 rapid antigen testing
Estimated Size: 250000000
- The bill aims to increase the availability of COVID-19 rapid antigen tests.
- Rapid antigen tests improve accessibility for individuals seeking to test for COVID-19, especially outside traditional healthcare settings.
- Can particularly benefit people who have difficulty accessing PCR testing sites or prefer not to wait for test results.
- Potentially allows widespread testing which could help in controlling outbreak hotspots.
- Faster testing can facilitate safer environments in public spaces, workplaces, and schools.
Reasoning
- The primary goal of this policy is to improve access to rapid COVID-19 tests in the US by streamlining approval processes. This especially affects individuals who rely on rapid testing either due to convenience or necessity. As such, this can impact a wide range of people, but mostly those in occupations or environments where frequent contact with others is commonplace.
- The budget constraints suggest that the program cannot cover costs for the entire population but can significantly enhance access in critical areas such as schools, workplaces, and densely populated communities.
- Considering cost and program size, the policy will have a greater impact on people from lower socioeconomic backgrounds due to traditionally limited access to healthcare, including diagnostic testing.
- The wide availability of tests may not significantly impact individuals who are already frequently accessing healthcare services due to their insurance coverage or geographic location near testing facilities.
- Many Americans would appreciate the increased accessibility and speed of these tests, which would impact their daily lives especially in scenarios involving events or public gatherings.
Simulated Interviews
School Teacher (New York, NY)
Age: 35 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- As a teacher, having rapid access to COVID tests would make me feel more secure in my environment.
- Increasing testing would likely minimize disruptions from outbreaks in schools.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
College Student (Los Angeles, CA)
Age: 22 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- Rapid antigen tests would let me visit my family during holidays without worrying about bringing COVID back to campus.
- Testing access in dorms should reduce anxiety among students.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
Farmer (Rural Kentucky)
Age: 46 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- Rapid tests would save us a long trip to a testing center, which isn't available nearby.
- I think this will help people in rural areas know their status more easily.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 4 |
| Year 20 | 5 | 4 |
Tech Executive (San Francisco, CA)
Age: 60 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- I already have access to testing, so this policy doesn't change much for me personally.
- However, it might make getting back to work safer for others around me.
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 |
Event Organizer (Miami, FL)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Easier access to rapid tests can help clients feel safer and more comfortable attending events.
- This policy could make it easier to manage events during a surge.
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 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Healthcare Worker (Detroit, MI)
Age: 40 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- Having more rapid tests available could make managing patient flow easier and allow us to treat more people safely.
- It's not a huge game changer for healthcare settings, but it's helpful.
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 | 6 |
| Year 20 | 6 | 6 |
Small Business Owner (Houston, TX)
Age: 55 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Rapid testing can help keep staff and customers safer, especially if there's another wave.
- Making tests more accessible is good for peace of mind.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 4 |
Gig Economy Worker (Chicago, IL)
Age: 32 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- Frequent testing helps me stay on the job without the fear of unknowingly spreading the virus.
- I would feel more at ease interacting with others regularly.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Retail Worker (Phoenix, AZ)
Age: 24 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Access to tests means less worry about bringing COVID home from work.
- It will help us act faster if someone at home is exposed or showing symptoms.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Retired (Seattle, WA)
Age: 68 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 8/20
Statement of Opinion:
- The policy would allow me to continue volunteering without as much concern about my health.
- Rapid tests are convenient, and I support making them more available.
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 | 5 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Cost Estimates
Year 1: $300000000 (Low: $150000000, High: $450000000)
Year 2: $0 (Low: $0, High: $0)
Year 3: $0 (Low: $0, High: $0)
Year 5: $0 (Low: $0, High: $0)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Availability and cost-effectiveness of tests compared to PCR options.
- Public perception and willingness to use rapid antigen tests.
- Supply chain capacity and resilience to scale distribution rapidly.
- FDA resource availability to efficiently manage and oversee increased authorization demands.