Throughout the PDA-FDA Joint Regulatory Meeting that took place September 12-14, 2022 in Washington D.C., the subject of Remote Assessments (RA), also called Remote Interactive Evaluations (RIEs), was repeated over and over again in sessions. This is not a new thing, as the Guidance for Industry (GFI), “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency” (here) came out in April 2021. The GFI indicates that this evaluation strategy will end when the Public Health Emergency (PHE) is over; however, in speaking with some FDA officials at the conference, they indicated that some of the tools that have been created in support of the PHE that have been found to be successful in improving efficiencies, such as the RIE, will likely be retained after the PHE has expired.
So, you may be asking, what is an RIE and how might it benefit my company? First, let’s discuss what it is not, an RIE is NOT an inspection, and it cannot be utilized as a substitute for an inspection. It is a voluntary evaluation that is initiated by FDA (e.g., you cannot request to have an RIE) for facilities where drugs are manufactured, processed, packaged, or held. An RIE is one of several remote interactive tools that FDA may use to gather information remotely prior to, or following, other types of Regulatory Oversight Activities (such as inspections). FDA may use this as a tool to help gather information so that they can, for example, minimize risk associated with conducting inspections, as this allows them to potentially reduce the number of staff who need to physically visit or reduce the amount of time on site.
Once FDA determines that a RIE is appropriate for a facility or drug product (in preparation for a Pre-Licensing Inspection [PLI] or Pre-Approval Inspection [PAI], for example), they will notify the facility (and applicant, when appropriate). As this is voluntary, the correspondence from FDA will include a request for confirmation that they are willing to participate in the RIE. (This also indicates a willingness to utilize teleconference, livestream video, and screen sharing of data and documents, as requested.) FDA will also include with the correspondence the reason for the use of the RIE and the names of the proposed FDA staff to be involved, if known. The GFI gives details on what to expect if you are invited to have an RIE and you accept. Keep in mind- if you decline a RIE, this could impede FDA’s ability to make a timely regulatory decision. FDA expects that, if you accept, that you will treat this as if they were onsite, and, as they stated at the meeting, you won’t “suddenly have technical difficulties” in an area you don’t want FDA to see.
Because this is not an inspection, no 483s are issued after the RIE. However, a form 4003 will be issued by FDA requesting documents, and at the end of the RIE, a 4003A will be issued that says that they reviewed the items on the 4003. As initially implemented, that was the end of the RIE. However, after review of the process, it was realized that they were missing an essential feedback loop. Thus, FDA have now added Assessment Issue Letters (AILs) which gives the firm a list of observations. Though this is not an inspection, there is an expectation that you will respond to these observations within 15 days. FDA stated that responding to these observations may keep you from having further Regulatory Action.
According to the GFI- depending on the purpose and outcome of the RIE, the information and documentation may be used to support FDA’s assessment of pending applications (including approval decisions); preclude the need for an inspection; support other regulatory actions (positive or negative, such as a Warning Letter); and rank or prioritize a facility for inspection. Based on what I heard at the conference, this appears to be an excellent tool for FDA to retain in the long term due to its potential to enhance efficiency, permit timely regulatory action, and reduce risks to inspectors and facility personnel.
If you or your firm are in need of strategic advice in deciding whether this pathway would work for interacting with FDA, please reach out to us at LCS@LachmanConsultants.com.
