Have you wondered why, after an FDA inspection that is classified No Action Indicated (NAI) or Voluntary Action Indicated (VAI), the inspected firm is given a copy of the Establishment Inspection Report (EIR) relatively quickly, but when an Official Action Indicated (OAI) classification is assigned, the EIR is not sent?

During a Q&A session at the 2022 PDA/FDA Joint Regulatory Conference in mid-September in Washington, D.C., CDER Director of the Office of Manufacturing Quality Francis Godwin explained why drug firms generally do not receive a copy of the EIR immediately when they receive an OAI classification.

“It is a complicated question in that it is governed in part by disclosure law,” Godwin said. “An EIR is a federal document and is subject to the Freedom of Information Act (FOIA). In FOIA, there are certain exemptions.

“When we send an NAI (No Action Indicated) or VAI (Voluntary Action Indicated) classification letter we will provide a courtesy copy of the EIR. Historically, redaction lawyers received so many FOIA requests from every firm that was inspected that they recommended it was better to incorporate sending the EIRs as a matter of business when the inspection is ‘closed.’” That is what happens now.

“I put ‘closed’ into quotes because that is what the regulations say. The regulation is 21 CFR 20.64, which covers disclosure of FDA-related documents. If you look at a warning letter posted on our website you will see it is redacted, for example, with the code (b)(4).”

Exemption (b)(4) of FOIA permits agencies, as a matter of discretion, to withhold trade secrets and commercial or financial information obtained from a person which is privileged or confidential.

“There are other exemptions—for example, if there is a confidential informant, that will not be disclosed.

“There is also an exemption if the regulatory action is still pending and the matter is not considered closed. For most of FDA, when a firm is OAI, the regulatory action has already been taken, whether it is a warning letter, a regulatory meeting, or something else. In those cases, the matter is closed and it can be shared.

“However, as a result of the Generic Drug User Fee Amendments II (GDUFA II) and FDA’s ‘Concept of Operations’ (ConOps) we are letting firms know the OAI status before the regulatory action is taken. So, you will be told you are OAI but the EIR is not shareable because of the way the disclosure regulations are set up.”

For more from Francis Godwin, here are his responses to select Q&A at the 2022 PDA/FDA Joint Regulatory Conference.