Legal experts offer advice on managing inspections in a hybrid environment

Experts stressed the importance of effectively managing hybrid inspections for the pharmaceutical and medical device industries in a developing enforcement environment, especially amid turnover of experienced inspectors at the US Food and Drug Administration (FDA).
 
The remarks were delivered by legal and compliance experts during a panel on inspections at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference on 8 December.
 
One attorney on the panel asserted that FDA has limited ability to take enforcement action against firms for noncompliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) based on information collected from virtual inspections as the law mandates that violative findings can only be used against firms from onsite, boots on the ground inspections.
 
“Triple threat” of hybrid inspections
 
Jack Garvey, managing partner at Compliance Architects, said that the current hybrid environment combining traditional onsite inspections, remote regulatory assessments and record requests poses a “triple threat” and can throw the regulated industry “off balance.”
 
Garvey said it is important for companies to be able to manage the new dynamics of onsite and remote inspections. “If you are at an onsite inspection, and I have been on plenty … there is a huge element of managing the investigators.” This involves building trust with investigator and “being helpful” in a way that “is not too helpful,” he said.
 
It is also important be able to “push back” when needed and that “a lot of companies are relatively unsophisticated” at doing this.
 
For virtual inspections, companies should ensure the readiness of their IT department. “There is a much more data-centric review framework, where FDA wants to sit down and go through your computer systems, imagine doing that through a zoom call.”
 
To ensure readiness with all these modes of inspections, Garvey suggested that firms perform mock records requests, virtual reviews and onsite inspections.
 
Influx of inexperienced inspectors
 
It is even more important to be prepared during a time of mass turnover at the agency, as experienced investigators are leaving the agency and being replaced by beginners who are new to the field.
 
“Many of the inspectors are new to the agency so we feel there is a learning curve with getting them up to speed,” said Ami Simunovich, executive vice president and chief regulatory officer at Becton Dickinson.
 
Kalah Auchincloss, executive vice president of Greenleaf Health, agreed with Simunovich’s assessment and said she’s “heard anecdotally that many experienced inspectors have left and the ones replacing them are inexperienced. So that is changing the nature of onsite inspections.”
 
Are remote inspections official inspections?
 
During the meeting, one attorney called into question whether the information collected by FDA during a virtual inspection can be used to take regulatory actions against firms.
 
Neil Di Spirito, a partner at Brown Rudnick LLP, asserted that under Section 704(a)(1) of the FD&C Act, only physical “site entry” at establishments meets the definition of an inspection, and only the information collected during a physical inspection can be used as evidence against a firm. There, he added that the evidence or information collected from remote inspection can be called into question.
 
“Personally, I would love to try these cases because there is no precedent at this point and I don’t think you can make the statement that you are conducting an inspection, and even the FDA agrees that you are not conducting an inspection.” He added that the evidence collected from virtual inspections will not be enough to get above the administrative level “and you will have a good defense.”
 
Di Spirito added that “Congress may want to revise the Food, Drug, and Cosmetic Act to sidestep the ‘site entry’ limitations.”
 
FDLI meeting