Wait and then Hurry Up: After Long Delays, FDA Resumes Inspections with a Passion

Things are getting hectic for those of us who advise clients on FDA inspections: FDA is busy addressing its backlog of foreign and domestic inspections.

As COVID raged, FDA understandably postponed many GMP (Good Manufacturing Practice) and “Bi-Mo” (Bioresearch Monitoring, usually of sponsors of clinical trials or clinical trial sites) on-site inspections.  Less understandably, FDA performed very few remote inspections over the last two years (see prior blogposts here, here, and here).  FDA has avoided labeling these as “remote inspections”, preferring the terms “Remote Interactive Evaluation” for manufacturing sites and “Remote Regulatory Assessment” for Bi-Mo.  Indications are the agency is now shifting to just the “Remote Regulatory Assessment” term, but apart from some niceties associated with in-person inspections, the fact is that remote activities can and do lead to regulatory consequences just as inspections do.

Anecdotally, though, FDA inspections have resumed.  We have several clients whose BLAs, NDAs or ANDAs have not been approved awaiting pre-approval inspections, and, months after their PDUFA dates, inspections are finally being scheduled, both within the United States and abroad.  Similarly, we are hearing both from clients and indirectly about companies that are not clients that several inspections relating to ongoing or completed clinical trials are finally being performed, even months after submission of documents that normally would have resulted in earlier inspections.

This is good news for some and bad news for others.  The good news for those with pending applications that have passed all other regulatory requirements is that review of the applications may no longer be stalled by delayed pre-approval inspections, although it seems like inspections in China are still lagging due to the uptick in COVID restrictions there.  Some companies that have been placed on the Import Alert list pending reinspections may finally find relief.  The bad news for many sponsors of clinical trials, manufacturers, laboratories, or Clinical Research Organizations is that FDA may find serious regulatory violations (or, at least, regulatory violations FDA considers to be serious: we reserve the right to argue that the violations are not so serious) that can have disastrous enforcement consequences, including clinical holds, withholding approvals of New Drug Applications or Abbreviated New Drug Applications, import detentions, Warning Letters, and, worst of all, shutdown injunction[1] requests or criminal investigations.

Time for a plug: two of your three bloggers (Dave and Doug) will be speaking at GMP by the Sea, a usually annual conference on hot topics of cGMP compliance that may result in FDA inspections, linked here.  GMP by the Sea was postponed twice because of COVID.  It looks like we will finally be able to resume being wined, dined, educated, crabbed, and networked this summer (conference is August 15 through 17, 2022, in Cambridge, Maryland, on the Eastern Shore of the Chesapeake Bay).

[1] The term “consent decree” denotes a negotiated settlement of a civil action, usually an injunction.  This occurs when the defendants choose to negotiate rather than contest the action in court.  Consent decrees may also occur in connection with seizure actions, but most often they are associated with injunctions.