“We are seeing an increasing frequency of inspections from FDA and the rest of the world,” says John O'Connor, PhD, senior director of Corporate Inspection Management for Genentech. “The question is, what’s the value of a duplicate inspection? We don’t believe it adds value to the product. But it costs us.”
O’Connor spoke May 19 at the BIO meeting in Atlanta, citing ample data that show how global regulatory bodies (most notably, FDA and Brazil’s ANVISA) are increasing their foreign inspections, to the detriment of those who must welcome them with open arms and open documentation.
Genentech has begun tracking the costs of regulatory inspections. By company estimates, says O’Connor, it costs $130,000 to $400,000 per day to support an inspection; 1,000 to 2,500 person hours are consumed per inspection.
Sure, inspectorates need guarantees that regulations are met, and are there to ensure safe medicine for the patient, says O’Connor. But inspections carry not only significant costs to the manufacturer, but to the agencies who perform them as well. “The concern that I have is that these resources aren’t being directed toward other quality efforts,” he says, citing anticounterfeiting as just one area in need of greater support and attention.
O’Connor also shared data on the habits of regulators during their visits. The most intriguing nugget: While FDA spends approximately 75% of its time on site reviewing documentation (and thus 25% touring the facility), EMEA is just the opposite, spending three-quarters of its time touring. Most other global regulatory agencies spend the majority of their time on documentation, O’Connor noted.
More on this talk to come . . .