The COVID-19 pandemic resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities suspended due to the pandemic, FDA was forced to pilot new and unfamiliar inspectional initiatives, including remote interactive evaluations, increased use of records requests under 21 USC 374(a)(4) — commonly known as 704 requests — and increased reliance on other health authorities’ inspections under the Mutual Reliance Agreement.
On July 22, 2022 the FDA released new draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers” (the RRA Guidance), describing the agency’s plan to continue to use these alternative inspectional initiatives beyond the COVID-19 pandemic. FDA’s continued use of these tools, broadly defined as “remote regulatory assessments” or RRAs, reflects the agency’s shift toward a “modernized approach” to oversight of FDA-regulated products and establishments1.
FDA’s formal adoption of RRAs as an oversight tool allows the agency to prioritize resources in a risk-based manner for a targeted on-site inspectional approach and use records obtained through RRAs to prepare for on-site inspections2. It also potentially creates an additional regulatory step for industry to demonstrate ongoing compliance. Managing and responding to an RRA differs significantly from managing an inspection and responding to an FDA 483, and manufacturers will need to adjust their approach accordingly to ensure successful outcomes.
FDA’s RRA Guidance, which is styled as a question-and-answer document, broadly defines remote regulatory assessments to include “an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements.” Depending on the type of assessment involved, an RRA may include a combination of record requests, virtual meetings with the establishment, and/or the use of livestream to examine the facilities data, operations, and information3.
According to the guidance, FDA intends to request RRAs whenever it is “appropriate to help fulfill the Agency’s regulatory responsibility and protect human and animal health … and to support regulatory decisions and oversight activities4.” This includes, for example, when travel restrictions limit the agency’s ability to conduct in-person inspections, to conduct establishment oversight, or to support regulatory decisions5, although the guidance also makes clear that FDA is not accepting requests to perform RRAs. Notably, FDA does not consider RRAs to be replacements for inspections, meaning that sites currently on OAI (official action indicated) status are unlikely to be cleared through an RRA.
The guidance describes two categories of RRAs:
1. Voluntary RRAs have included “records assessments and/or interactive evaluations (such as remote livestreaming video of operations, teleconferences, and screen sharing) conducted pursuant to voluntary participation by industry7.”
Declining to participate in a voluntary RRA will not result in any enforcement action by the agency but may delay FDA assessments or lead FDA to consider other actions, such as an inspection, to exercise the agency’s oversight responsibilities8.
2. Mandatory RRAs have included “requests for records or other information from drug establishments under section 704(a)(4) of the FD&C Act, and requests for [Foreign Supplier Verification Program] records under 21 C.F.R. 1.510(b)(3) and 1.512(b)(5)(ii)(C)9.”
According to the guidance, withdrawing participation or refusing to provide records may be considered declining to participate in a mandatory RRA. An establishment that declines a mandatory RRA may be in violation of the Food, Drug, and Cosmetic Act, and FDA may take “appropriate action10.”
FDA may combine observations gathered during an RRA with any observations from a subsequent inspection11. When FDA completes an RRA, the agency may meet with establishment management. The agency may also provide a written list of conditions and/or practices observed that indicated a potential violation12. Although FDA does not issue a Form FDA 483, List of Inspectional Observation, at the conclusion of an RRA, it may provide updates on observations and issues during RRA and encourages establishments to respond during the meeting or to provide written responses within 15 U.S. business days13. FDA will typically prepare a report summarizing its review and findings, which it will provide to the establishment when the RRA is closed.
The guidance also details potential benefits of having RRAs precede inspections. These potential benefits include identifying issues that may enhance an establishment’s preparation for its next inspection, optimizing FDA’s time on site by reducing the number of records the agency needs to review, and allowing FDA to make regulatory decisions without an inspection when appropriate conditions are met14.
What to Expect Next
The RRA Guidance confirms what we suspected all along: that FDA will continue to use its records request authority and remote interactive evaluation tools to carry out its regulatory oversight responsibilities even if the agency resumes normal on-site inspections. On the one hand, the increased use of RRAs could allow FDA to conduct more targeted on-site inspections and to more nimbly navigate shortages and potential shortages. On the other hand, RRAs could lead to enhanced scrutiny of critical, especially foreign, manufacturing sites and additional layers of FDA oversight of manufacturers overall.
Manufacturers will also need to balance the benefit of participation in “voluntary” RRAs against the burden of responding to what can end up being multiple rounds of information requests and the potential that the RRA will lead to action by FDA. In addition, manufacturers should assess their existing processes and technological capabilities to ensure readiness for such requests and to ensure that RRAs are handled with a level of professionalism, diligence, and urgency similar to on-site inspections.
1 See FDA Statement, FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health (July 22, 2022); FDA, Conducting Remote Regulatory Assessments: Questions and Answers: Draft Guidance for Industry at 5 (July 2022).
3 Id. at 10.
4 Id. at 7.
5 Id. at 7-8.
6 Id. at 6; See FDA Statement, FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health.
8 Id. at 11.
9 Id. at 6.
10 Id. at 11.
11 Id. at 8.
12 Id. at 15.
14 Id. at 9.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship. Readers should not act upon this information without seeking advice from professional advisers.
Attorney Advertising—Sidley Austin LLP, One South Dearborn, Chicago, IL 60603. +1 312 853 7000. Sidley and Sidley Austin refer to Sidley Austin LLP and affiliated partnerships, as explained at www.sidley.com/disclaimer.
© Sidley Austin LLP