Ask and Ye Shall Receive, But Don’t Ask FDA for a Virtual InspectionApril 15, 2021
Ask and ye shall receive, if yer requests are vocal and repeated, and ye are patient, and willing to accept less than ye ask for.
For more than a year we have been asking FDA to initiate virtual or remote inspections of drug manufacturing facilities. FDA has conducted only a handful of on-site inspections – and no virtual inspections – of drug manufacturing facilities since the COVID epidemic shut down foreign travel 13 months ago. FDA’s failure to perform inspections of foreign drug manufacturing facilities made it impossible for many companies to close out Warning Letters, climb off the Import Alert list, or secure approvals of drug applications delayed because FDA insisted on an on-site inspection (see blogposts with catchy titles like “FDA Fiddles with Remote Inspections While Pharma Burns” and “Conducting Virtual Inspections: EMA and MHRA Do It, CMOs Do It, Why Won’t FDA Do It?”). Regulatory agencies other than FDA have been performing virtual inspections for much of the past year.
Finally, on April 14, FDA issued a guidance addressing (in large part), these concerns. It spells out the procedures to be followed for what FDA labels “Remote Interactive Evaluations,” with an explanation that these “interactions” will not meet the statutory definition of an “inspection.” The Guidance also sets forth when FDA will ask for companies to cooperate in these “interactions,” and when FDA won’t. But, overall, the “interactions” will look and feel a lot like a virtual inspection. FDA says it “will use its own IT platforms and equipment to host virtual interactions during remote interactive evaluations (e.g., videoconferences, livestreaming video of the facility and operations in the facility).” It says that it expects the regulated entity to cooperate in the use of “livestream and/or pre-recorded video to examine facilities, operations, and data and other information.” And FDA will host prior brief virtual meetings to discuss logistics and responsibilities during “livestreaming walkthroughs of the facility.”
While FDA states that these “evaluations” are not inspections, there are a lot of features that are very similar to inspections. “After the remote interactive evaluation concludes,” the agency states, “FDA will provide a copy of the final remote interactive evaluation report to the facility.” This report is explicitly not a Form 483, which is delivered with observations about significant deviations at the conclusion of about half of the inspections of drug-manufacturing facilities. But it will have many of the same features, especially since, “As with an inspection, FDA encourages facilities to respond during the discussion and/or provide responses in writing to the observations within 15 U.S. business days,” the same deadline set for responding to a Form 483. Also, if the interactive evaluation is a supplement to an inspection, FDA “usually will combine any observations from the remote interactive evaluation(s) into a single written list of observations issued at the close of the inspection, which would be issued on a Form FDA 483.”
A puzzling footnote (footnote 11) says that FDA will not supply equipment for the virtual noninspection, nor can it accept equipment to conduct the virtual noninspection. We suppose that the point is that the facility must provide owned or rented equipment to permit the virtual tour, but cannot give it to the Agency, or it might look like a bribe.
And don’t you dare ask for an “Interactive Evaluation” in lieu of an inspection. “We will not accept requests from applicants or facilities for FDA to perform a remote interactive evaluation,” FDA says. “Such decisions depend on many factors and information not always known to applicants or facilities, and it would be too burdensome on all parties to establish a request-based program.”
We wonder whether a prohibition on asking for an “Interactive Evaluation” would survive constitutional challenges based on First Amendment Free Speech rights, or the constitutional right to petition the government to redress grievances. When a company responds to an Informational Letter that states their drug approval will be delayed because FDA insists on a pre-approval, or pre-license, inspection, what would be wrong with the company suggesting that a “Remote Interactive Evaluation” might be appropriate? Where is the government’s compelling interest in prohibiting such a request?
Oh well. To paraphrase the immortal words of Mick Jagger, “you can’t always get what you want, but if you try sometime you find, you get what you need” – after 13 months of reasoning, arguing, pleading and, finally, kvetching.