Bill Overview
Title: Modernizing Therapeutic Equivalence Rating Determination Act
Description: This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. (A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)
Sponsors: Rep. Curtis, John R. [R-UT-3]
Target Audience
Population: Individuals relying on drug equivalence for medication
Estimated Size: 3000000
- The bill affects pharmaceutical companies applying for new drug approvals via the 505(b)(2) application pathway, a less common pathway generally used for drugs that are similar but not identical to already approved drugs.
- Pharmaceutical companies depend on the FDA equivalence ratings for marketing their drugs as therapeutically equivalent to existing treatments.
- Healthcare providers rely on therapeutic equivalence ratings to make informed decisions about prescribing drugs, particularly when considering generics.
Reasoning
- The primary beneficiaries of this policy will be generic drug manufacturers and patients who seek affordable medication alternatives.
- The policy aims to streamline the process of obtaining therapeutic equivalence ratings, which could increase the availability of generics, typically encouraging market competition and reducing drug costs.
- Healthcare professionals and patients who rely on equivalence ratings for ensuring drug safety and efficacy will be indirectly impacted.
- Pharmaceutical companies may need to adapt operationally to expedite their equivalence rating requests, but the direct financial impact will predominantly affect those relying on the medications produced under these approvals.
Simulated Interviews
Pharmacist (Boston, MA)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This policy could help us provide customers with more affordable drug options faster.
- Therapeutic equivalence ratings are crucial for ensuring the safety and effectiveness of generics prescribed.
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 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Biopharmaceutical Researcher (Seattle, WA)
Age: 32 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- We often rely on the 505(b)(2) pathway due to limited resources for conducting new trials.
- This policy could streamline our market entry process, notably impacting our business viability.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Insurance Policy Analyst (New York, NY)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Lower drug costs through more available generics could benefit insurance coverage planning.
- Streamlining FDA processes reduces delays in realizing these savings.
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 | 8 |
| Year 20 | 8 | 8 |
Cardiologist (Dallas, TX)
Age: 53 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Patients often ask for more affordable medications.
- Ensuring equivalence ratings are readily available helps me prescribe generics without hesitation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
New Drug Approval Specialist (San Diego, CA)
Age: 28 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 4/20
Statement of Opinion:
- The sooner we get equivalence ratings, the sooner we enter the market and start benefiting patients.
- This policy could enhance my work's impact by shortening timelines.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Retired (Rural Iowa)
Age: 60 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 12.0 years
Commonness: 7/20
Statement of Opinion:
- Prescription medication costs are a significant concern in my limited budget.
- If more generics become available and prices drop, it could improve my financial situation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
General Practitioner (Chicago, IL)
Age: 40 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- Affordable medications are essential for my patients who have limited access to healthcare.
- The policy seems like a move in the right direction for community health.
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 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Policy Maker (Atlanta, GA)
Age: 47 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 3/20
Statement of Opinion:
- This bill could significantly lower drug costs and improve healthcare accessibility.
- Such policies are the backbone of equitable healthcare legislation.
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 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Healthcare Advocate (Philadelphia, PA)
Age: 55 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- Ensuring drugs can be more affordable through generics is a cornerstone of my advocacy work.
- This policy could be a game changer in terms of drug cost and accessibility.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Graduate Student (Los Angeles, CA)
Age: 22 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Policy reforms like this make the pharmaceutical industry more dynamic.
- Fast-tracking equivalence ratings can accelerate innovation in generic drugs.
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 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 9 | 8 |
Cost Estimates
Year 1: $5000000 (Low: $4000000, High: $6000000)
Year 2: $4000000 (Low: $3000000, High: $5000000)
Year 3: $3000000 (Low: $2000000, High: $4000000)
Year 5: $3000000 (Low: $2000000, High: $4000000)
Year 10: $3000000 (Low: $2000000, High: $4000000)
Year 100: $-1 (Low: $-1, High: $-1)
Key Considerations
- The FDA's capacity to handle additional procedural workload efficiently.
- Potential pushback from brand-name drug manufacturers due to increased competition from generics.