Risk Evaluation and Mitigation Strategies: For manufacturers, do REMS represent a tremendous potential for confusion or an opportunity for growth? Perhaps both. Manufacturers who implement effective programs can enhance patient access to medications, further ensure appropriate utilization and potentially improve patient outcomes. Manufacturers whose execution falls short stand to lose market share or even risk increased regulatory scrutiny.
In the second installment of this two-part series, Pharmaceutical Executive’s Joanna Breitstein continues to explore the potential impact of new REMS programs. Jay Jackson, senior director for healthcare consultancy Xcenda, meets with Joanna to discuss how REMS can create advantages for a product, what health outcomes data can be collected as part of a REMS and what benefits a REMS can offer to patients, providers and payers.