6 Criteria to Assess Your REMS Consultant Options--Insights from ParagonRx

Stinson Brand Innovation regularly works with partners who specialize in complementary areas of brand support. For pharmaceutical safety risk management issues, we have teamed up with ParagonRx, a premier firm in the development, submission, implementation, and coordination of Risk Evaluation and Mitigation Strategy (REMS) programs – not only to address what the FDA expects, but also to assure appropriate use and support commercial brand success.

Here is an article by Jeff Fetterman, president of ParagonRx, that appears in the current issue of our ACCELERATE Newsletter. Jeff brings a mix of corporate and entrepreneurial leadership to his role. His background includes leading cardiovascular marketing, clinical education, and strategic planning at DuPont Pharmaceuticals and serving as COO for DuPont Consumer Health. He is a co-author of Pharmaceutical Risk Management: Practical Applications.



Back in 2006, most pharmaceutical managers responded to the topic of risk management with an aversion, saying “If I ever have a drug with genuine safety concerns, I’ll call you.” Today, everyone is talking about risk management…and for good reason.

The FDA Amendment Act of 2007 granted FDA sweeping new authority to require Risk Evaluation and Mitigation Strategies (REMS) of any product at any stage of lifecycle. In response, industry had three immediate questions:
1. What determines if REMS will be necessary?
2. How actively will FDA implement the REMS provisions?
3. Who should think about risk management?

REMS is needed for interventions beyond labeling to adequately mitigate risk. The ultimate arbiter of that assessment is FDA, but industry sponsors can influence the decision with rigorous benefit-risk assessments and contingency planning.

We’ve seen FDA actively implement REMS provisions, with one-third of all new chemical entities approved in 2008 requiring a REMS.

Based on this trend, you should think about risk management if you are on:
- A brand commercialization team in late-stage development or pre-launch planning. Because the probability of a REMS is 1 in 3, you should develop contingency plans to avoid delay in registration.
- Any brand team developing 505.b.2 products. While the molecule may have extensive data supporting a favorable benefit-risk profile, a new delivery system may introduce new patient hazards. FDA has requested several sponsors in this situation to conduct failure mode and effects analysis (FMEA) to determine if a REMS is needed.
- The brand team of any currently marketed product with serious adverse events (SAEs). To adequately mitigate risk, a brand team should both continually update the product’s benefit-risk profile and consider developing REMS contingency plans.

With the emerging importance of REMS, many service providers and consultants are offering REMS support. Here are some criteria to help assess your options:
1. Experience -- Have they designed risk management programs for at least 5-10 brands, to offer the benefit of significant cross-product experience?
2. Expertise -- Do staff members have expertise that has been published and recognized among risk management peers?
3. Methods -- Do they utilize validated evidence-based methods (such as FMEA) to reliably develop programs?
4. Independence -- Is program design separate from operations after program launch, to avoid concern about bias?
5. HCP Collaboration -- Do they have a process to collaboratively design with your customer – healthcare providers?
6. Flexibility -- Can they create a process and a culture to customize planning that balances the needs of regulators, patient safety, and corporate performance?

For more information, please visit http://www.paragonrx.com/