In the first of what’s expected to be a series of REMS-related advice for the industry, the FDA on Monday unveiled new draft guidance on how to improve the safety programs often attached to higher-risk drugs.
The 26-page draft lays out the FDA’s thinking to help sponsors design, implement and evaluate a risk evaluation and mitigation strategy, or REMS. The programs can, for example, require drugmakers to develop communication plans with patients and doctors, or take other steps to reduce potential safety issues.
The draft looks into three phases of a REMS lifecycle: design, implementation and evaluation.
In the design phase, the FDA says sponsors should start by “assessing the situation context and establishing a goal for the REMS.” Part of that assessment should include a “care gap assessment,” the FDA says, which involves “identifying the discrepancies in risk mitigation between clinical trial protocols, best practices, and the actual care that is provided.”
The next phase is the implementation phase, during which the FDA says sponsors should consider the data used to evaluate if a REMS is being implemented as intended.
The last phase is the evaluation phase, where sponsors will understand if a REMS is working. “When developing program outcome indicators for REMS, applicants should prospectively identify the key performance indicator(s) that demonstrates if the REMS program is meeting its goal,” the FDA says.
But the agency also makes clear in this morning’s Federal Register that its framework does not have to be part of a linear process, and “involves moving back and forth or toggling between steps and phases to address uncertainties, validating assumptions, incorporating new information, and refining the program.”
Building on 2013 recommendations from HHS’ Office of the Inspector General, the agency said that Monday’s draft is meant to fulfill one of its performance goals under the sixth reauthorization of the Prescription Drug User Fee Act.
