Definition
Post-Marketing Commitment (PMC) is a study that a drug sponsor agrees to conduct after FDA approval. Unlike Post-Marketing Requirements (PMRs), PMCs are not required by statute but are commitments the sponsor makes during the approval process.
How Post-Marketing Commitments Work
FDA and sponsors negotiate PMCs during the approval process. These studies address questions that don’t require resolution before approval but are important for comprehensive safety and efficacy understanding.
PMC vs PMR
| Type | Legal Basis | Consequence |
|---|---|---|
| PMC | Voluntary agreement | Reputational, regulatory relationship |
| PMR | Statutory requirement | Potential enforcement action |
Common PMC/PMR Types
- Confirmatory Trials: Verify clinical benefit after accelerated approval
- Safety Studies: Long-term safety monitoring
- Pediatric Studies: Required under PREA
- Drug Interaction Studies: Identify clinically significant interactions
- Carcinogenicity Studies: Long-term cancer risk assessment
PMC Status Categories
| Status | Meaning |
|---|---|
| Pending | Not yet started |
| Ongoing | Study in progress |
| Submitted | Final report submitted |
| Fulfilled | FDA accepted completion |
| Released | No longer needed |
Why BD Teams Track Post-Marketing Commitments
For business development professionals, PMCs affect asset evaluation:
- Deal Implication: Outstanding PMCs represent future costs and potential risks
- Due Diligence Focus: Review PMC/PMR status and timeline feasibility
- Opportunity Signal: Failed confirmatory trials can lead to accelerated approval withdrawal