What is a VAI or OAI Regulatory Meeting?

Did you know that FDA sometimes holds regulatory meetings to discuss a Voluntary Action Indicated (VAI) or Official Action Indicated (OAI) inspection outcome with the inspected drug manufacturer? What is the purpose of these meetings and how do they differ from one another and other regulatory meetings?

While many are familiar with the Types A, B, C, and D regulatory meetings that FDA holds with drug sponsors during drug development as outlined in the 2023 FDA guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” the post-inspection meetings are less well-known.

At the PDA/FDA Joint Regulatory Conference 2024 held in Washington, DC, September 9-11, 2024, during a panel discussion after the session, “Current GMP Compliance Trends and Topics,” FDA regulators discussed the OAI and VAI meetings, what they are, why they are held, and the benefits to FDA and the companies participating in the meetings.

FDA Center for Drug Evaluation and Research (CDER) Office of Manufacturing Quality (OMQ) Office of Compliance (OC) director Francis Godwin began the discussion.

“Regulatory meetings can come in various types,” he explained. “When we classify a facility as OAI, or Official Action Indicated, it means we consider the facility out of compliance with CGMP (Current Good Manufacturing Practice). We may have an OAI regulatory meeting if we have already issued a warning letter and we want to talk to the firm one more time to go into the details before we consider pursuing legal action with the DOJ (Department of Justice).”

“We may also do an OAI regulatory meeting if we want to have very detailed technical discussions on matters where the process of a letter going to the firm and then replying might be better handled by just getting them in the room and walking them through a few things and getting feedback directly from them,” Godwin pointed out.

A VAI regulatory meeting, he said, “may take place when the evidence and the issue at hand does not rise to considering the facility to be out of compliance. However, there may be a few things we want them to button up and make sure that they understand or get them over the hump in terms of some corrective actions, etc.” A VAI regulatory meeting is “kind of a lighter regulatory meeting” where we may say, “Yes, we think you are in compliance but we want to recommend that you look at this, look at that, or you need to think about these other things.” The idea is to “facilitate voluntary compliance” from firms.

At the end of every regulatory meeting, even though a classification letter has already been signed, “we tell the firm if we think they are in or out of compliance so it is very clear to everyone what the agency’s current thinking is regarding the CGMP compliance of the site,” the center director concluded.

Director of the Compliance Branch in the FDA Office of Pharmaceutical Quality Operations Ronda Loyd-Jones commented, “We like to try to educate while we regulate. And sometimes those regulatory meetings are necessary to just kind of open up a dialogue, a discussion. We don’t get that same input with a letter. We will tell them or ask them certain questions and certain things that we want to discuss during the meeting and vice versa, and then we open up the floor. It is an opportunity for us to have open dialogue that we normally do not get when issuing a letter, especially for a VAI. We are trying to help them get in compliance before they get to an OAI status.”

Center for Biological Research and Evaluation (CBER) Biological Drug and Device Compliance Branch Chief Daniel DeCiero concurred. “I would definitely agree there, especially with some of our products. In terms of how a product is regulated, it is a really great tool to help educate the firms that come in to reiterate why their product is regulated in a certain way and really work through those challenges.”

FDA Center for Veterinary Medicines (CVM) Division of Drug Compliance Consumer Safety Officer (CSO) Marea Banks discussed priorities for the post-inspection regulatory meetings in her office.

“At CVM, we make it a priority during those meetings to re-emphasize information that may have already been communicated during the inspection, that may have already been communicated as a deficiency in correspondence post-inspection. This is a tool where CVM is able to say, through our management and our compliance officers, to company management that may have already heard it, but as another way of forewarning or re-emphasizing that there are certain takeaway points that CVM and the agency feel are significant that need to be addressed.”