Cavazzoni: FDA wants to prevent manufacturing stoppages during inspections

The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER).

Cavazzoni made these remarks during a webinar hosted by the Alliance for a Stronger FDA on Monday, during which, she said “we strongly encourage manufacturers not to stop manufacturing as the result of an inspection.” She added that manufacturers sometimes shut down production lines based on what they are hearing during the inspection, which she said could worsen shortages.

Her remarks were in response to a question on how the agency is addressing drug shortages. She said FDA is “very worried about drug shortages” and noted that shortages are lasting longer as there are more conflicts to resolve. In addition, there is more reliance on “one or two manufacturers to make very important essential drugs.”

As part of FDA’s inspection modernization efforts, the agency is piloting a program to enhance communication between the investigators, the drug shortage team, and the compliance team. Such communication would take place on an ongoing basis and before, during and after an inspection. This would allow the investigators to have some context as to what is manufactured at the facility.

During inspections, “We really want manufacturers to call our drug shortage team immediately because we want to start problem solving with manufacturer as soon as possible during the course of the inspection so we can try to put in place some of the mitigation approaches that we have to make sure that we don’t find ourselves with outright stoppages in the manufacturing of essential drugs like what we have seen over the past year.”

In other areas, Cavazzoni was asked to address how the agency is addressing AI. She said, “We are seeing a real uptick in applications in INDs [Investigational New Drug Applications] and a growing number of more advanced programs that contain AI elements.”

Cavazzoni noted that incorporating AI tools will involve a “radical transformation” of the regulatory framework. It would also require huge outlays for high-performance computational technology to ingest and compute data from applications.

FDA would also need a new policy on retaining records as, and Cavazzoni bemoaned the potential hardware and storage costs related to analyzing and storing these algorithms. “The cost of bringing in these huge algorithms and then retaining them forever and storing them somewhere would be absolutely cost prohibitive.”

Cavazzoni was also asked to address how the agency is trying to improve its postmark surveillance methods. When it comes to postmarket safety, we are spending a lot of time these days in thinking about the new iterations of Sentinel,” she said.

The agency is mulling the possibility of retooling Sentinel to include more data from electronic health records (EHRs) as well as using a more modular method to collect data on an as-needed basis.

She added that “unfortunately we have not been successful in getting any targeted funding for Sentinel.”

Another priority is for CDER to have a “high performing” electronic gateway to enable the acceptance of more cloud-based submissions.

Cavazzoni: FDA wants to prevent manufacturing stoppages during inspections

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