Bill Overview
Title: CLEAR Act
Description: This bill requires the Food and Drug Administration to regulate contrast agents for medical imaging devices, radioactive drugs, over-the-counter monograph drugs, and ophthalmic drug articles (i.e., eye droppers) as drugs rather than medical devices.
Sponsors: Sen. Smith, Tina [D-MN]
Target Audience
Population: Individuals using medical imaging, radioactive drugs, OTC monograph drugs, and/or ophthalmic drug articles
Estimated Size: 250000000
- The act involves the regulation of medical imaging contrast agents, radioactive drugs, over-the-counter monograph drugs, and ophthalmic drug articles.
- Anyone using medical imaging would likely be impacted by these regulations as contrast agents are crucial for many such procedures.
- The use of radioactive drugs typically pertains to specific diagnostic tests or treatments (like cancer treatments), which affects people undergoing such treatments.
- Over-the-counter drugs are commonly used by a large portion of the population for various minor ailments.
- Ophthalmic drug articles, such as eye droppers, are used by individuals with eye conditions or those who require eye lubrication or medication.
Reasoning
- The CLEAR Act is likely to impact a wide range of people, predominantly those using over-the-counter (OTC) drugs, as these are common in everyday life.
- The impact on people using medical imaging will be notable but less widespread compared to OTC drug users.
- Individuals using ophthalmic articles like eye drops are less in number but will also observe changes.
- Budget constraints suggest that the FDA's regulatory changes will reach a significant portion of the population but will target developed areas more effectively.
- The policy's financial layout implies a strong initial focus, with a sustained rollout over 10 years affecting more niche drug uses gradually.
Simulated Interviews
IT Specialist (Los Angeles, CA)
Age: 32 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 15/20
Statement of Opinion:
- I rely a lot on OTC drugs and I've used imaging for health checks quite frequently.
- If regulations improve safety, it's worth the trouble, but I hope it doesn't make access or cost worse.
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 | 8 | 6 |
| Year 20 | 8 | 6 |
Nuclear Medicine Physician (Houston, TX)
Age: 45 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- My professional life revolves around these materials, so clear regulations will help improve treatment safety.
- The policy must carefully balance between improving safety and ensuring availability.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 7 | 8 |
Retired School Teacher (Syracuse, NY)
Age: 70 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 8/20
Statement of Opinion:
- I'm concerned about the pricing if regulations change eye medications.
- Still, safety improvements could be crucial for older individuals like myself.
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 | 6 | 5 |
| Year 20 | 5 | 5 |
Graduate Student (Chicago, IL)
Age: 27 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 14/20
Statement of Opinion:
- I hope this doesn't lead to increased costs or hassle in getting OTC meds and imaging.
- Clearer safety guidelines are a good thing, but execution is key.
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 | 8 | 6 |
Pharmacist (Miami, FL)
Age: 50 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- This is likely to impact how we stock and educate clients about OTC and eyedrop drugs.
- I just hope the transition is smooth for both professionals and consumers.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Marketing Manager (Portland, OR)
Age: 29 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 16/20
Statement of Opinion:
- I'm not personally worried, but any improvement in safety is a win.
- I hope it doesn't create shortages or higher costs.
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 |
Retired Engineer (Phoenix, AZ)
Age: 60 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 8/20
Statement of Opinion:
- Proper regulation is important, but it shouldn't make accessing medication difficult or more expensive.
- Improved safety would be appreciated.
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 |
Medical Imaging Technician (New York, NY)
Age: 41 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 7.0 years
Commonness: 5/20
Statement of Opinion:
- I foresee more precise rules increasing safety in imaging procedures.
- The execution of new regulations is crucial to avoid operational burdens.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Retired (Kansas City, MO)
Age: 65 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- Any step towards safer drugs and procedures is worthwhile, but they need to remain affordable.
- I'm worried about potential increases in drug prices.
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 | 6 | 5 |
| Year 20 | 5 | 5 |
Healthcare Policy Analyst (Seattle, WA)
Age: 38 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 20.0 years
Commonness: 6/20
Statement of Opinion:
- This policy is crucial for aligning safety standards.
- It will be interesting to observe market responses and adaptation to new regulations.
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 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 9 | 7 |
Cost Estimates
Year 1: $88000000 (Low: $65000000, High: $110000000)
Year 2: $90000000 (Low: $67000000, High: $115000000)
Year 3: $92000000 (Low: $69000000, High: $118000000)
Year 5: $95000000 (Low: $71000000, High: $125000000)
Year 10: $99000000 (Low: $75000000, High: $130000000)
Year 100: $100000000 (Low: $75000000, High: $132000000)
Key Considerations
- Large scale of population potentially impacted, requiring extensive regulatory adjustments.
- The shift may require significant initial investment but could lead to long-term efficiency gains in regulation processes.
- Market reactions from pharmaceutical and medical device industries should be closely monitored.