Bill Overview
Title: Drug Shortages Shelf Life Extension Act
Description: This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates. Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; (2) establishing on drug labels the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages and affect product quality; and (3) using innovative approaches to stability modeling to support initial product expiration dates and expiration date extensions. The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.
Sponsors: Rep. Matsui, Doris O. [D-CA-6]
Target Audience
Population: people who use or depend on medications for healthcare
Estimated Size: 235000000
- The bill focuses on the extension of drug expiration dates, which is directly related to drug availability, particularly for those medications that are prone to shortages.
- Patients who rely on medications that often face shortages will be directly impacted, as extended expiration dates may improve drug availability.
- Healthcare providers who prescribe, manage, and dispense medications will be impacted by any changes to drug expiration dates since this will affect their supply management practices and patient care.
- The manufacturers of drugs will be impacted as they will need to adapt to new guidelines for stability testing and possibly change their product labeling and data submission processes.
- The overall healthcare system, which comprises of hospitals, clinics, pharmacies, and insurance companies, will see changes due to a potential reduction in drug shortages.
- As drug shortages can have global implications, international healthcare systems and patients may indirectly benefit from improved availability of American-manufactured drugs.
Reasoning
- The policy is aimed at addressing drug shortages by extending the expiration dates of drugs, ensuring they are still effective and safe beyond their original shelf life. This could benefit patients and healthcare providers by ensuring a more stable supply of medications.
- Healthcare providers may see a decrease in stress related to managing drug inventories and ensuring patient access to necessary medications during shortages.
- Patients with chronic conditions relying on medications at risk of shortages could see improvements in their wellbeing due to more consistent access to these drugs.
- However, the immediate impact on individual wellbeing may be low as the changes might not translate to personal experiences immediately and may be more systemic.
- Manufacturers might face initial costs and operational burdens to comply with the new FDA guidelines but could benefit long-term through improved drug viability and sales consistency.
- The policy's success in improving overall wellbeing may depend on the effective implementation of FDA guidelines and the cooperation of drug manufacturers.
- Population segments less reliant on prescription drugs will likely see minimal direct impact.
Simulated Interviews
Retired school teacher (California)
Age: 65 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- I always worry about running out of insulin during shortages. It affects my health when my supply is low.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 4 |
Pharmacist (Texas)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Managing drug supplies is very stressful during shortages. Hopefully, extended expiration dates will ease this.
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 | 6 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Health policy analyst (New York)
Age: 30 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- If implemented well, the policy could significantly reduce shortages and improve system efficiency.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Pharmaceutical company executive (Ohio)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- The initial cost of compliance might be high, but long term benefits could stabilize the market.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 9 | 5 |
Hospital administrator (Florida)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- Drug shortages disrupt hospital operations significantly. Extended expiration dates could be a solution.
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 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Graduate student studying pharmacology (Illinois)
Age: 28 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- The policy encourages research into stability, potentially leading to scientific advancements.
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 nurse (Massachusetts)
Age: 72 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- It's scary not being able to get my medications when they run out. Anything that helps is a good change.
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 | 4 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 4 |
General practitioner (Arizona)
Age: 38 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- Ensuring medications are available to my patients is a huge part of my job. Extended expiration dates can help.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 6 |
Public health official (Michigan)
Age: 40 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Stability in drug availability is key for public health. This policy can potentially support that.
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 | 7 | 6 |
| Year 20 | 6 | 5 |
Cardiologist (New Jersey)
Age: 55 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 6/20
Statement of Opinion:
- I often worry about patients not getting their meds on time due to shortages. This policy could ease these worries.
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 | 7 | 6 |
| Year 20 | 7 | 5 |
Cost Estimates
Year 1: $10000000 (Low: $8000000, High: $12000000)
Year 2: $10000000 (Low: $8000000, High: $12000000)
Year 3: $9000000 (Low: $7000000, High: $11000000)
Year 5: $8000000 (Low: $6000000, High: $10000000)
Year 10: $6000000 (Low: $4000000, High: $8000000)
Year 100: $500000 (Low: $300000, High: $700000)
Key Considerations
- The standardization and acceptance of extended drug expiration dates will require collaboration between the FDA and pharmaceutical companies.
- Public perception and market acceptance of expired drugs, even if proven safe and effective, will play a critical role in the policy's success.
- The bill's monitoring and reporting requirements could ensure transparency and accountability, thereby enhancing trust in the revised expiration guidelines.