Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

Regulatory NewsRegulatory News | 28 September 2022 |  By 

Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel that are subject to live-streaming.
 
While FDA has been conducting remote assessments since the start of the pandemic, its guidance, once finalized, would formalize its plan to use these assessments to supplement onsite inspections as it eases out of the pandemic response mode. The draft guidance was released in May. (RELATED: FDA describes plans to expand remote regulatory assessments, Regulatory Focus, 22 July 2022)
 
The agency received 26 comments on the guidance, with responses from a wide range of medical device and pharmaceutical trade groups, as well as consumer and food industry groups.
 
PhRMA: More information needed on coordinating onsite and remote inspections
 
The Pharmaceutical Research and Manufacturers of America (PhRMA) wants more clarity on how RRAs would be coordinated with onsite inspections to avoid duplication of effort.
 
“PhRMA largely agrees with the benefits of RRAs that FDA cites in the draft guidance. However, PhRMA strongly encourages FDA to address, in the draft guidance or otherwise (e.g., MAPP, SOPP), the Agency’s process for coordinating internally on RRAs. For example, we recommend FDA establish internal procedures to ensure that, in the case of an on-site inspection following an RRA, the inspectors have access to information previously collected as part of the RRA. Greater transparency across FDA will help to realize the benefits for both FDA and biopharmaceutical companies in reducing duplication of effort.”
 
The group also wanted clarity on how RRAs could be leveraged by foreign inspections in lieu of onsite inspections.
 
“While we recognize that RRAs are not inspections, we nevertheless think it would be helpful for FDA to articulate how RRAs might be leveraged by foreign regulators, for example by those capable regulatory authorities recognized under mutual regulatory agreements. This will help enable foreign regulators to take FDA’s RRAs into account when conducting oversight activities, which in turn will help further a globally efficient approach to manufacturing oversight.”
 
PhRMA also urged FDA to extend the 15-day timetable for responding to observations noted in an RRA.
 
AAM: Can RRAs can be used to close out warning letters?
 
The Association for Accessible Medicines (AAM) suggested FDA provide more clarity on whether RRAs can be used to reclassify a facility from Official Action Indicated (OAI) status to a compliance status or whether they can be used to close out a warning letter.
 
“AAM believes RRAs can be a valuable tool for FDA to determine whether it is appropriate to reclassify a facility from OAI status or to close out a warning letter. FDA indicates in the Draft RRA Q&A Guidance that the Agency may use RRAs to reclassify facility status or to close out a warning letter, but it is not necessarily made clear.”
 
Device groups want clarity on benefits of RRAs, inspection schedules
 
The Advanced Medical Technology Association (AdvaMed) urged FDA to better embellish the advantages of RRAs.
 
AdvaMed said that “FDA should highlight throughout the document the potential benefits of less frequent or reduced duration/scope of inspection for participants in an RRA. We request that FDA include language in several instances in the document denoting the possible benefits of participating in the RRA in terms of reducing the frequency, scope, and duration of inspections. Consideration of participation in an RRA can be incorporated into FDA’s risk-based inspection schedule and lead to less frequent inspections at an establishment, reduced duration of time spent at the establishment, and/or reduced scope of inspection.”
 
The group also wants FDA to clarity who has the authority to request an RRA as well as the mechanism for tracking the RRAs within the agency.
 
The Medical Device Manufacturers Association (MDMA) wants more clarity on how RRAs will feed into FDA’s risk-based inspection schedule.
 
MDMA writes that “it is not clear how FDA will use the RRA in determining a site’s risk-class-status for scheduling future inspections. In addition, MDMA believes that FDA should clarify how it intends to utilize RRAs with establishments that participate in the Medical Device Single Audit Program (MDSAP) or other programs that FDA recognizes in lieu of an inspection. We would also appreciate information on how FDA plans to collaborate with MDSAP auditors to share information generated from an RRA.”
 
MDMA also said that certain terms in the guidance appear to be inconsistently used in the guidance. For example, terms such as “observations,” “concerns,” and “potential violations,” are “used inconsistently.”
 
PDA and BIO: Want more disclosures on using livestream video
 
The Parenteral Drug Association (PDA) and the Biotechnology Innovation Organization (BIO) requested that the final guidance add text to recognize how video-recording personnel during RRAs will comply with country and region-specific privacy regulations, such as the EU’s General Data Protection Regulation (GDPR).
 
The draft guidance permits the use of livestream or pre-recorded video to examine facilities, operations, data and information.
 
BIO wrote that the final guidance should include “recommendations on how to ensure privacy of personal and proprietary information during live streaming.”
 
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