FDA Policy/General

Comments on Remote Assessment Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the use of alternative tools for oversight of FDA-regulated products. Commenting on an agency draft guidance on questions and answers about conducting remote regulatory assessments (RRAs), PhRMA raises issues under two general headings in which it says FDA should (1) provide details on its processes regarding the initiation and closing out of RRAs and (2) further clarify the potential benefits of RRAs.

The Association for Accessible Medicines says the agency should:

clarify that it will consider the use of RRAs for other scenarios in addition to those specified in the draft, including for reclassification of a facility from OAI (official action indicated) status and for closing out Warning Letters;
allow firms to request an RRA;
clarify what criteria it will consider when determining whether to pursue a mandatory records request or a voluntary records request;
clarify its policies, procedures, and intended timeline for following up with a firm after an RRA;
clarify that if a firm reasonably declines a voluntary RRA request in the pre-approval context, FDA will endeavor to use alternatives to the requested RRA to try to ensure user fee goal dates are met; and
clarify its policies for conducting RRAs during oversight activities conducted by authorities other than FDA.

In its response, AdvaMed says RRAs for medical devices are currently voluntary and until legislative authority is granted, the voluntary nature of the program for devices in any FDA guidance must be further underscored. It makes these recommendations:

FDA should add to the draft a question addressing who in the agency is authorized to initiate a request for an RRA, the mechanism for tracking RRAs within FDA, and intra-agency coordination;
FDA should highlight throughout the document the potential benefits of less frequent or reduced duration/scope of inspection for participants in an RRA;
FDA should engage in an interactive discussion with the company detailing the contours of the RRA in advance of requesting a company to agree to participate;
FDA should provide daily, interactive updates during the RRA;
FDA should outline appropriate protections for documents and data received from the establishment as part of the RRA;
need for issuance of a report for all voluntary RRAs and understanding public availability of the report;
closing any RRA before any inspection, or specifying that an RRA will automatically close with the initiation of an inspection; and
FDA should provide additional public documents outlining the RRA process and internal procedures.

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