Post-Marketing
However mature your product is, you often hear physicians saying, "It's too much trouble"; patients saying, "I'm concerned"; or payers informing you, "We don't see an advantage".
At any time, regulators can impose additional mandates for post-marketing surveillance or communication. Often, you can anticipate and mitigate these by taking a proactive approach to program development. However, you may still receive a letter mandating a new Risk Evaluation & Mitigation Strategy (REMS). Or market conditions and your commercial strategy may dictate putting a patient safety/appropriate use program in place.
With a risk mitigation program in place, you are required to monitor its performance and submit any necessary refinements for approval. With business, competitive, scientific and field intelligence continually hitting your desk, it's not always easy to do what's right for your product, physicians and patients.
A research-informed approach can identify the most important risks perceived by clinicians, address those concerns with best practices and provide other tools to optimize use. When your stakeholders are confident that risk has been mitigated wherever possible, confidence in the therapy increases across the board.
You know that appropriate use programs can help ensure that your product reaches its potential, up to and including the presence of generics. It's never too late to mitigate risk and optimize use, especially as new clinical data emerge and "old standbys" look better than ever. But your product has such a long history...where do you start?