Healthcare Professional MLR Review Email Readiness Checklist

Role: Principal Medical Communications & MLR Email Compliance Lead

Context

• Therapeutic Indication: {{drug_indication}}
• Recipient Cohort: {{target_hcp_specialty}}
• Fair Balance & Risk Profile: {{fair_balance_guidelines}}
• Core Clinical Claims: {{promotional_claims}}
• Governing Regulatory Framework: {{regional_regulatory_body}}
• Campaign Type: {{unbranded_vs_branded_mode}}

Task

Generate a comprehensive pre-submission MLR readiness checklist to audit every component of an upcoming healthcare professional email campaign, ensuring zero regulatory deviations, compliant claim-to-evidence linkage, and airtight safety disclosures before formal review.

Method

1. Cross-reference all subject lines, preheaders, and header copy against {{promotional_claims}} to confirm no misleading efficacy assertions exist.
2. Evaluate header and body layout to confirm {{unbranded_vs_branded_mode}} distinction guidelines are strictly maintained without premature commercial exposure.
3. Map every clinical claim to its primary source citation, auditing footnote formatting against {{regional_regulatory_body}} validation standards.
4. Audit the prominence, readability, and placement of Important Safety Information (ISI) and Boxed Warnings relative to {{fair_balance_guidelines}}.
5. Inspect all destination links, Prescribing Information (PI) anchors, and Adverse Event reporting pathways for single-click accessibility.
6. Review tone and medical terminology to ensure appropriateness for {{target_hcp_specialty}} without trivializing risk profiles.
7. Establish email template technical fallbacks, ensuring safety content renders legibly across desktop, mobile, and plain-text clients.

Constraints

• Checkpoints MUST be categorized into distinct functional review stages.
• Checkpoints MUST NOT use ambiguous verification criteria; every item must have a binary pass/fail condition.
• MUST include explicit citation validation rules for all clinical claims.
• MUST include mandatory checks for Black Box warning typography and contrast ratios.

Output format

Return a markdown checklist formatted into exactly 4 sections:

1. Section A: Header, Subject Line & Claim Scrutiny (4-5 checks)
2. Section B: Fair Balance, ISI & Prescribing Information (4-5 checks)
3. Section C: Source Substantiation & Link Integrity (3-4 checks)
4. Section D: Viewport & Client Rendering Verification (3-4 checks) Each item must follow the syntax: [ ] **[Check ID] [Component]**: [Verification Criterion] | **Remediation Trigger**: [Action if failed]

Self-review

• Confirm all 6 variables ({{drug_indication}}, {{target_hcp_specialty}}, {{fair_balance_guidelines}}, {{promotional_claims}}, {{regional_regulatory_body}}, {{unbranded_vs_branded_mode}}) are accounted for.
• Verify every checklist item contains both a binary verification criterion and an explicit remediation trigger.
• Ensure the output contains no vague marketing platitudes and is strictly MLR-compliant.