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; and (2) establishing on drug labels the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages. 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: Sen. Cardin, Benjamin L. [D-MD]
Target Audience
Population: Individuals who rely on medications and healthcare providers
Estimated Size: 250000000
- The bill targets the pharmaceutical industry by requiring guidance on drug expiration dates, which affects manufacturers.
- Drug shortages affect healthcare providers who may struggle to access necessary medications for patient care when shortages occur.
- Individuals relying on medications are directly impacted by drug shortages, as it can affect their health outcomes.
- The FDA's guidance may influence market dynamics by extending the shelf life of drugs, potentially reducing wastage.
Reasoning
- The budget constraints limit the scope of immediate large-scale impacts, likely focusing initially on high-impact medications or critical shortages.
- The pharmaceutical industry and healthcare systems are complex, with changes potentially impacting operations, costs, and patient outcomes, especially those with chronic conditions.
- Well-being impacts will vary based on individual dependency on medications. More immediate benefits will likely be seen in populations experiencing frequent drug shortages, such as certain chronic condition communities.
- Healthcare providers may experience a subtle improvement in operational efficiency over time, as drug unavailability impacts day-to-day routines and patient care negatively.
Simulated Interviews
Pharmacist (Houston, TX)
Age: 34 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- This policy could alleviate some of the pressure we face when dealing with shortages.
- Extended expiration dates might help prevent wastage, making our budgets stretch further.
- I'm cautious about the reliability of extended dates; patient safety is a priority.
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 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Chronic Patient (Salt Lake City, UT)
Age: 45 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- Running out of medication is terrifying; extending drug availability would be a huge relief.
- I hope this policy makes manufacturers more responsible about supply management.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 4 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 4 |
| Year 20 | 7 | 4 |
Retired (Miami, FL)
Age: 68 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 12/20
Statement of Opinion:
- If extending expiration dates leads to lower costs, that would help financially.
- I'm worried it might be a temporary fix without addressing underlying supply issues.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 4 |
Research Scientist (Los Angeles, CA)
Age: 29 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 6/20
Statement of Opinion:
- Our work will be directly impacted by this policy, requiring adjustments in our testing and stability protocols.
- This act might streamline drug approval processes related to expiry dates.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Physician (Indianapolis, IN)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- This could allow us to provide medications consistently to our patients and improve treatment outcomes.
- But, this won’t solve all our supply chain issues.
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 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Student (New York, NY)
Age: 23 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- It’s nerve-wracking when meds aren't available; this policy might help.
- I fear there may be additional hoops to jump through that delay real benefits.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 4 |
| Year 20 | 8 | 3 |
Healthcare Administrator (Chicago, IL)
Age: 39 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This act may optimize our supply chains if expiration dates are reliably extended.
- However, ensuring compliance across manufacturers might introduce challenges.
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 | 5 |
| Year 20 | 6 | 5 |
General Practitioner (Seattle, WA)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 4.0 years
Commonness: 14/20
Statement of Opinion:
- Understanding how expiration dates impact medication availability is crucial.
- Hope to see this actually lead to fewer shortages over time as supply stabilizes.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 4 |
| Year 20 | 6 | 4 |
Supply Chain Manager (Boston, MA)
Age: 42 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- A reliable extension in shelf life could streamline operations and reduce logistics pressure.
- This change might be complex to implement across existing products.
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 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 5 |
Public Health Official (Denver, CO)
Age: 31 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This policy could enhance existing strategies to manage shortages.
- Collaboration between FDA and manufacturers will be essential for success.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Cost Estimates
Year 1: $50000000 (Low: $30000000, High: $70000000)
Year 2: $50000000 (Low: $30000000, High: $70000000)
Year 3: $50000000 (Low: $30000000, High: $70000000)
Year 5: $50000000 (Low: $30000000, High: $70000000)
Year 10: $50000000 (Low: $30000000, High: $70000000)
Year 100: $50000000 (Low: $30000000, High: $70000000)
Key Considerations
- Effect on the pharmaceutical industry in terms of compliance and adjustments needed for drug labeling practices.
- Potential for reducing drug shortages through extended shelf life, benefiting patients and healthcare institutions.
- Balancing the rigor of stability testing with the flexibility in expiration date guidelines to ensure drug safety and efficacy.