Metrics for monitoring prescribing patterns to identify changes in access to opioid products may not be in place when FDA approves REMS for individual products.
The missing element is the methodology.
“It will take a number of months to develop detailed methodology with a research organization,” the Industry Working Group told the FDA in a communication seeking guidance on the agency’s expectations for the REMS. IWG is developing the shared implementation program for the risk management plan and has met with the FDA several times to clarify the agency’s expectations.
The access analysis is one of seven components of the assessment plan The FDA imposed when in April it unveiled its requirements for the opioid REMS. “The IWG has already proposed a high-level overview of the [prescriber pattern] methodology in the proposed REMS, with more detailed methodology to be developed after the REMS is approved,” IWG said.
The FDA seems willing to accept a staggered launch of the program. While the methodology may be only in draft form in the sponsors’ REMS submissions, they should provide a schedule “for expeditious completion of the methodology,” according to the agency.
Class-wide REMS and shared REMS assessment program do not eliminate the need to look at whether individual products are being used more safely.
The agency clarified that its request for drug-specific information does not refer to the active drug substance, dosage form or delivery method. Rather, the agency wants “as much detail as possible for each individual product, including each unique dosage form/delivery system.”
Industry is concerned about “providing comparative data on competing products and would prefer to perform general surveillance, looking at the changes in adverse events for the class or at the level of active drug substance, rather than for specific products.”
