The discussion of inspections “have been a central discussion point” of the trip, especially as the FDA is proposing a plan “to create a new approach to facility inspections, one that will not only note problems, but will also allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance,” Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, and Cynthia Schnedar, Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research, said in a blog post from Tuesday.
Although Sklamberg and Schneder offered few specifics on the new plan, they did say that simply put, inspections will now yield “carrots,” and “not just sticks.”
Such “carrots,” or positives, discovered from an inspection “could be used to influence the frequency of our inspection of a particular facility, and possibly even support regulatory flexibility around post-approval manufacturing changes. These kinds of decisions would be anchored by data that proves that the risks of manufacturing problems in a certain facility are minimal.”
The FDA also says it will be piloting a new questionnaire that could further standardize inspections, with the goal of uniformly collecting data that supports accurate measures of quality.
Quality Culture
And although the agency says it cannot inspect its way to drug quality, many of its discussions on the India trip have focused on the importance of enhancing the “quality cultures” of Indian firms.
“Of course, enforcement has been, and will continue to be, an important part of our program to ensure drug quality. Enforcement is a particularly appropriate tool when a firm does not submit accurate data to us. FDA relies on information to do its job, and faulty information means that we cannot ensure the quality of the drugs that the firm produces,” the agency says, especially as recent inspections have uncovered a number of questionable data practices at firms such as Apotex, Micro Labs and Sun Pharma.
The FDA says it will continue to work with the Indian government through workshops and joint inspections to raise awareness and understanding of FDA’s inspections processes.
“And to the industry leaders we have met with here, we have pledged to continue to collect their feedback on how we might be able to help them improve regarding quality issues, and to incentivize them to do so,” Sklamberg and Schneder write.