Drugs

Stakeholders Ask REMS Guidance Changes

The Biotechnology Innovation Organization (BIO) says a draft FDA guidance on format and content of a Risk Evaluation and Mitigation Strategy (REMS) document should include additional requirements for REMS programs run or administered through specialty pharmacy healthcare settings. The additional requirements should include enhanced/expanded communication with prescribers and/or patients, which is within the workflow for specialty pharmacies, the association comment letter says.

BIO also says the guidance should specify:

who is responsible for storage and retention of certain REMS participant documents;
who is responsible for monitoring patients subject to REMS; and
the duration of retention of participant materials.

Celegene’s comment asks FDA to consider the possible ramifications of listing specific participant requirements of a REMS participant without an association with a particular type of REMS element. “Overall, we agree that participation in REMS programs can be made easier for our stakeholders through REMS program standardization and integration into established clinical practice and the electronic systems used in support of those practices,” Celgene says. “As Celgene is actively working to incorporate our REMS programs into established workflows and REMS participants’ electronic systems (e.g., electronic medical records, pharmacy management systems, etc.), we encourage FDA to continue to lead this initiative.”

Pharmaceutical Research and Manufacturers of America (PhRMA) says the guidance is overly prescriptive and may not allow for necessary modifications. It says that greater flexibility should be allowed for sponsors, particularly for existing REMS programs that may deviate slightly from the guidance.

PhRMA also recommends that FDA publish a completed sample template for applicants and calls for additional guidance and standardization for exceptions to the REMS requirements for stakeholders with a specific rationale or when doing so would provide more benefit than risk in those specific situations.

In its response, Sanofi give specific line-by-line comments.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome