By Nicholas J. Diamond
On July 22, the U.S. Food and Drug Administration released draft guidance entitled Conducting Remote Regulatory Assessments: Questions and Answers (FDA-2022-D-0810). A corresponding notice of availability was posted in the Federal Register on July 25. The draft guidance indicates FDA’s intention to continue to use remote tools to support oversight activities, including a hybrid approach for inspections that combines both onsite and remote modalities, beyond the COVID-19 pandemic. The draft guidance is open for comments until September 23.
What are remote regulatory assessments?
Remote regulatory assessments (RRAs) are a type of remote oversight tool that FDA may use to support regulatory decisions and oversight activities. RRAs include, for example, “remote interactive evaluations,” on which FDA has previously released guidance for their use during the pandemic. As FDA clarifies in the draft guidance, an RRA is an “examination” rather than an inspection (in most cases), because the latter involves FDA physically entering an establishment for purposes of determining compliance with FDA requirements. According to the accompanying FDA statement, FDA has performed more than 1,470 domestic and more than 600 foreign entity establishment RRAs in the last two years.
RRAs may be mandatory, such as requests for records or other information from drug establishments under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or voluntary. FDA may request that an “establishment” (i.e., any facility, entity, person, importer, or site, whether foreign or domestic, subject to the laws administered by FDA) participate in a voluntary RRA, but the establishment is not required to participate. However, as the draft guidance states, although declining a voluntary RRA does not result in any enforcement action by FDA, it may delay FDA in making a timely decision on a product approval, clearance, or authorization.
Why does FDA use remote regulatory assessments?
FDA has leveraged remote oversight tools, such as RRAs, extensively during the pandemic. This has allowed FDA to continue its oversight activities, despite travel restrictions or other pandemic-related limitations. The draft guidance catalogues examples where FDA may initiate or request to conduct an RRA. For example, RRAs may be used alongside other oversight activities, such as in preparation for a forthcoming inspection or supporting the review of a marketing submission.
RRAs provide FDA with flexibility in conducting oversight activities, which can result in efficiencies for the inspection process and, subject to certain conditions, even approval of an application of authorization for emergency use without an inspection. FDA is concurrently seeking an expansion of its authority for conducting RRAs in its fiscal year (FY) 2023 budget, which includes an expansion of its authority to request records or other information in advance of or in lieu of inspections to include all FDA-regulated products (not just drugs) by amending the FD&C Act.
What should companies know about remote regulatory assessments?
The draft guidance provides context on RRAs to assist establishments that may be unfamiliar with the process. For example, FDA may, among other things, request and review records (including electronic systems), conduct virtual meetings, or use livestream to examine facilities and operations. These activities may vary, depending on whether it is a mandatory versus voluntary RRA.
The draft guidance also clarifies the process following an RRA. After completion of an RRA, FDA may conduct a meeting with the management team to present a written list of “observations” (i.e., conditions or practices observed that may indicate potential compliance violations), if any. Importantly, any such written list may be subject to a request under the Freedom of Information Act.
What’s next?
Companies subject to FDA regulation should expect FDA to continue to use RRAs beyond the pandemic. Indeed, the draft guidance clearly documents the value of RRAs, from the perspective of FDA, and begins to clarify outstanding questions from industry on the future use of RRAs. In general, establishments should welcome this continued emphasis from FDA because, as the experience during the pandemic has borne out, the flexibility of RRAs, especially for foreign entity establishments, may ultimately translate to more efficient and timely market entry. Nevertheless, given the request in the FY2023 FDA budget, industry should closely monitor the potential for expanded authority for RRAs because this would likely raise new questions requiring further clarification from FDA via future guidance.
This alert is not intended to provide legal advice, and no legal or business decision should be based on its contents. Please consult with your legal counsel for guidance.