Bill Overview
Title: To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.
Description: This bill requires the Food and Drug Administration to solicit public comment on factors that should be taken into account when considering proposed modifications to approved risk evaluation and mitigation strategies for drugs. The Government Accountability Office must report on the number of proposed modifications that have been granted and the related effects on patient access or provider administration with respect to such drugs.
Sponsors: Rep. Joyce, John [R-PA-13]
Target Audience
Population: People affected by modifications to risk evaluation and mitigation strategies for drugs
Estimated Size: 30000000
- The bill affects the evaluation and mitigation strategies for drugs, which are generally applied to medications with known serious risks.
- Patients who rely on medications with existing risk evaluation and mitigation strategies (REMS) and who might benefit from improvements in how risks are managed would be directly impacted.
- Healthcare providers who prescribe and administer these medications would also be impacted, as changes in REMS could affect how they manage patient treatment.
- Pharmaceutical companies that manufacture drugs under REMS protocols would be affected because they may need to amend their compliance practices based on public feedback and resulting modifications.
- Policy makers and healthcare regulators would be involved in reviewing and implementing changes based on public comments.
Reasoning
- The policy targets drugs with risk evaluation and mitigation strategies, affecting patients, healthcare providers, and pharmaceutical companies.
- The population most affected includes those using high-risk medications with serious side effects, which account for a smaller subset of all medications.
- The policy could improve drug safety, access, and administration by incorporating public input on REMS modifications.
- Healthcare professionals may experience a change in prescribing or monitoring practices resulting from REMS updates.
- Pharmaceutical companies might face additional compliance requirements, potentially affecting drug pricing and availability.
Simulated Interviews
retired nurse (Florida)
Age: 68 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I support this policy because involving the public in REMS discussions could improve the safety of the medications I rely on.
- It will be beneficial if modifications to REMS can be expedited while maintaining safety.
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 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
pharmaceutical executive (California)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy could add operational challenges, but it also promotes the responsible marketing of high-risk medications.
- We appreciate public feedback as it helps us align our strategies with patient needs.
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 | 6 | 7 |
physician (New York)
Age: 36 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This bill is promising as it could streamline processes that currently delay patient access to necessary drugs.
- Public input might highlight practical challenges in the current REMS protocols that healthcare providers face.
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 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
drug safety advocate (Oregon)
Age: 27 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 2/20
Statement of Opinion:
- Although public feedback is essential, it is crucial that the policy incorporates actionable changes in the REMS protocols
- I'm hopeful that this legislation will prioritize patient stories and lead to tangible safety improvements.
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 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 9 | 5 |
hospital administrator (Texas)
Age: 54 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Effective public involvement in REMS modification could improve hospital protocols and patient outcomes.
- This could pose an additional administrative burden if not implemented efficiently.
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 | 7 |
| Year 20 | 8 | 7 |
educator (Ohio)
Age: 41 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- I'm optimistic that this policy could address communication gaps and empower patients in understanding REMS.
- Changes based on patient experiences can enhance adherence and understanding.
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 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
government policy advisor (Massachusetts)
Age: 60 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 1/20
Statement of Opinion:
- The bill could enhance our framework for evaluating medications, improving public trust in pharmaceutical governance.
- Public feedback is crucial for dynamic policy adjustments to REMS.
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 |
patient (Illinois)
Age: 33 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The ability to comment on REMS could make my medications more accessible and safer.
- I value that the policy aims to reduce barriers to necessary medications.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
pharmacist (Georgia)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- The policy could simplify the prescription process for high-risk drugs, making it easier to keep my patients informed and safe.
- Public feedback must be treated with urgency to see prompt changes.
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 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
health policy researcher (Colorado)
Age: 48 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- This will provide a data-driven approach to impact assessment, crucial for refining REMS programs.
- The link between public feedback and policy alterations needs to be transparent and efficient.
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 |
Cost Estimates
Year 1: $5000000 (Low: $3000000, High: $7000000)
Year 2: $5000000 (Low: $3000000, High: $7000000)
Year 3: $5000000 (Low: $3000000, High: $7000000)
Year 5: $5000000 (Low: $3000000, High: $7000000)
Year 10: $5000000 (Low: $3000000, High: $7000000)
Year 100: $5000000 (Low: $3000000, High: $7000000)
Key Considerations
- The cost assessment assumes efficient handling of public comments and reporting by the FDA and GAO.
- Potential scalability based on the volume of public feedback and necessary in-depth evaluation of complex REMS suggestions.
- Possibility for some decentralized innovation and adjustments to REMS processes that could drive cost-effectiveness over time.