Bill Overview
Title: Increasing Prescription Drug Competition Act
Description: This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.) Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay). The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.
Sponsors: Sen. Hassan, Margaret Wood [D-NH]
Target Audience
Population: People dependent on prescription drugs globally
Estimated Size: 220000000
- The bill affects the pharmaceutical industry, impacting the approval process for generic drugs, which can affect a large number of individuals dependent on medications.
- By facilitating the entry of generic drugs into the market, drug prices could decrease, impacting consumers who require these drugs for their health conditions.
- The bill could impact individuals dependent on specific brand-name drugs by potentially increasing access to cheaper alternatives.
- Pharmacists and healthcare providers might be affected as they adjust to the new availability of generics under modified REMS regulations.
Reasoning
- The target population for this policy primarily includes people who use prescription drugs, especially those who may benefit from lower costs through increased availability of generic options. This could include the elderly, low-income individuals, and Americans with chronic health conditions.
- The $25,000,000 budget for the first year limits initial impact, possibly focusing on regulatory updates and initial rollouts affecting smaller segments first, like specific high-cost drugs. Over 10 years, the $250,000,000 budget suggests broader market effects and potential reductions in drug costs could enhance access over time.
- About two-thirds of U.S. adults use prescription drugs, translating to approximately 220 million people. However, not all will be directly impacted immediately due to specific drug patents and the gradual process of market entry for generics under modified REMS rules.
- Healthcare professionals and pharmacists are secondary stakeholders who must adapt to regulatory changes and the changing landscape of available medications.
Simulated Interviews
retired (Florida)
Age: 68 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- I really hope this policy makes my medications more affordable.
- With my fixed income, I sometimes have to choose between buying medicine or other necessities.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 7 | 5 |
pharmacist (New York)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Increased generic availability is helpful, but adjusting to new regulations can be a hassle.
- In the long term, it can drive business by reducing costs for consumers.
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 | 9 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
healthcare advocate (California)
Age: 55 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This policy is overdue. Lowering drug costs can save lives especially in underserved areas.
- We need immediate and tangible results for those who are most vulnerable.
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 | 10 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
software engineer (Texas)
Age: 32 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 4.0 years
Commonness: 10/20
Statement of Opinion:
- Prescription costs are high. I'm excited to see if generics will make a difference.
- I'm skeptical if the policy will roll out soon enough to affect the drugs I need.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
hospital administrator (Michigan)
Age: 38 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- Lower drug costs could significantly reduce hospital expenses.
- I expect the transition may initially increase workload to navigate changes.
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 | 7 | 7 |
| Year 20 | 7 | 7 |
retired (Ohio)
Age: 70 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 8/20
Statement of Opinion:
- Medicines are already affordable for me through the VA.
- I hope this helps others who aren't as lucky with their benefits.
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 |
freelance writer (Washington)
Age: 26 | Gender: other
Wellbeing Before Policy: 4
Duration of Impact: 6.0 years
Commonness: 6/20
Statement of Opinion:
- Generic options could make my antidepressants affordable.
- Currently, paying out-of-pocket is a huge burden.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 6 | 4 |
primary care physician (Illinois)
Age: 60 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- More generics could improve my patients' adherence to treatment plans.
- Changes in REMS will need careful consideration to maintain 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 |
small business owner (Oregon)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 1.0 years
Commonness: 10/20
Statement of Opinion:
- I support policies that help reduce healthcare costs.
- Generics are an essential part of affordable health.
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 |
graduate student (Massachusetts)
Age: 28 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- As a student, every dollar counts. Generic medicines could really help.
- I worry about long-term effects if REMS adjustments are not effective.
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 | 6 | 6 |
Cost Estimates
Year 1: $25000000 (Low: $15000000, High: $40000000)
Year 2: $25000000 (Low: $15000000, High: $40000000)
Year 3: $25000000 (Low: $15000000, High: $40000000)
Year 5: $25000000 (Low: $15000000, High: $40000000)
Year 10: $25000000 (Low: $15000000, High: $40000000)
Year 100: $25000000 (Low: $15000000, High: $40000000)
Key Considerations
- The speed of market entry for generic drugs will be critical to evaluating the real-world impact.
- Patent litigation dynamics could shift but might invite increased legal maneuvers.
- The extent of consumer behavior changes in response to reduced drug pricing needs monitoring.