Most clinical study sites have never been through a significant inspection by the U.S. Food and Drug Administration (FDA). So when the agency informs site leaders that one is coming, they can sometimes act like passive victims or a deer in the headlights.
It doesn’t have to be that way, says Dr. Darshan Kulkarni, principal attorney at the Kulkarni Law Firm. Sites can “help to guide” the visit in many ways, he suggests. First, it is important to stress that a site should not do anything to obstruct an FDA investigation. Not only is that wrong morally, it can escalate any fines or other potential enforcement actions by the agency.
However, FDA is often open when sites ask for some input on how to prepare. For example, “It’s okay to ask the FDA what their goal is in the inspection,” Kulkarni says. Tell the agency “you want to help them achieve what they want to achieve.” This is true for both for-cause and not-for-cause inspections, he adds.
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In many cases, the agency will be specific about its area of focus (e.g., data logs or electronic record integrity). “The FDA does not want to interfere with your day-to-day operations,” Kulkarni says. “They don’t want to obstruct your business.” That’s why they’re often open to helping narrow the exercise. In most cases, an inspector is very open to telling you what they want to focus on.
Sites do themselves a disservice if they fail to take any proactive action, Kulkarni says. An inspection can become an “open environment” in which inspectors go off in a number of directions, and the site may be caught unawares. “You don’t need to create that kind of environment,” he says.
Finally, remember that FDA inspectors are professionals and, in the vast majority of cases, very polite and open to finding the best ways to work with a site before, during, and after an inspection. “One of my clients called an FDA inspector an ‘idiot’ in an e-mail,” Kulkarni says. “That didn’t help anyone.”
Author: Michael Causey