Definition
REMS (Risk Evaluation and Mitigation Strategy) is an FDA-required drug safety program designed to manage known or potential serious risks associated with a drug while preserving patient access. REMS programs can range from simple patient information to complex distribution restrictions.
How REMS Works
FDA requires REMS when it determines that standard labeling is insufficient to ensure a drug’s benefits outweigh its risks. The program elements depend on the specific risk being managed.
REMS Elements
| Element | Description | Example |
|---|---|---|
| Medication Guide | Patient information sheet | Dispensed with each prescription |
| Communication Plan | HCP education materials | Dear Doctor letters, training |
| ETASU | Safe use requirements | Prescriber certification, registries |
| Implementation System | Operational infrastructure | Certified pharmacies, monitoring |
Common REMS Requirements
- Prescriber Certification: Must complete training to prescribe
- Patient Enrollment: Register in safety database
- Pharmacy Certification: Only certified pharmacies can dispense
- Laboratory Monitoring: Required tests before/during treatment
- Limited Distribution: Restricted supply chain
Why BD Teams Track REMS
For business development professionals, REMS affects commercialization:
- Deal Implication: REMS adds operational complexity and cost to commercialization
- Due Diligence Focus: Evaluate REMS burden and shared system availability
- Opportunity Signal: Single shared REMS can be barrier to generic entry