Start earlier than you plan to, challenge your own thinking, dig hard, and reach out to prescribers and patients. These tactics may be the keys to developing a successful risk evaluation and mitigation strategy (REMS), and to developing it as painlessly as possible.
Early-stage thinking about any REMS program needs to span the techniques you'll use to capture drug safety data beginning in the early stages of development, to the methods you'll use to assess the REMS program's effectiveness years after a drug launch. It's not the kind of long-term thinking where you identify an item or topic that you'll develop later. The FDA wants those end-game details fleshed out in the regulatory submission.
Here are the top tips from our REMS experts.
1. Start early, challenge conventional wisdom, have a plan
2. Do user and product homework; form cross-development team
3. Engage users and stakeholders; line up resources
New tool, old concept
For all the current drug industry emphasis on REMS, remember that the tool is relatively new as a staple in drug marketing approvals. Both FDA and the drug industry are still finding their way. That's not to say that risk-mitigation strategies are new. They've been part of the FDA arsenal in one form or another for years--initially as one-on-one negotiations between regulator and drugmaker, later as risk minimization action plans, or Risk MAPS. REMS implementations came along in 2007/2008, thanks to the FDA Amendments Act.
But it appears that the FDA plans to rely more heavily on such strategies in granting market approvals than it has in the past. And as experience rolls in on their use, the FDA is watching closely. It wants to apply lessons learned to its REMS requirements, driving the development of strategies that are more effective than their forerunners in getting prescribers and pharmacists to better inform patients of drug risk-benefit tradeoffs. And to more consistently get patients to be compliant in taking their meds.
Evidence that we're still at the formative stage of the regular use of REMS as a regulatory tool is all around us: Recent backlashes against their use by those taxed with implementation is, in fact, a likely sign that they are here to stay (though maybe not as currently envisioned). And the FDA's reported work on developing a five-item grid to aid its risk-benefit decision-making shows the regulator coming to grips with the tool.
Given the nascent nature of REMS, strategists can't begin thinking about mitigating risks too early in a drug's development. Following are some tips on what you can do before you begin to develop that strategy, and what you can do in process.
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