WASHINGTON, DC — CDER director Patrizia Cavazzoni on Monday stressed that while the agency is looking to reduce its backlog of surveillance inspections, pre-approval inspections will continue to uncover cGMP issues, lamenting that the timing of those uncoverings is “obviously not optimal.”
On the backlog of surveillance inspections conducted by the FDA, which has persisted since the pandemic, Cavazzoni said this year, “we will have conducted significantly more surveillance inspections” from last year. Speaking at a conference for manufacturers in Washington, she called 2025 “a crucial year for us to really get back to where we would like to be,” and noted that the FDA uses a risk-based approach to selecting sites for inspections. She also noted that for-cause inspections have returned to pre-pandemic levels.
User fee programs for new drugs, biologics and biosimilars don’t fund surveillance inspections, which Cavazzoni said is not only bad for the agency, but also that “it’s not a good situation for sponsors because I think that more surveillance inspections” in those facilities would actually prevent issues in the first place, instead of emerging during pre-approval inspections.
In contrast, Cavazzoni noted that the generic drug industry does fund such surveillance inspections, which she said has helped it overcome “some maturation growing pains” as the industry transitions from making solid oral drugs to more biosimilars and complex generics.
Surveillance inspections also can’t be conducted remotely, and on-site inspections have steadily grown since the pandemic in terms of the cause for a warning letter.
In response to a question on why the FDA won’t sometimes meet with companies after manufacturing issues are identified at a site, Cavazzoni said the agency does on occasion, and that it is working to increase communications sponsors during the review cycle, “keeping in mind that sometimes meetings may not be necessary or may actually not be possible, depending on where the application is in the review cycle.”
Generally, she said, companies find out the outcome of an inspection with a complete response letter or with a new drug’s approval.
“I’ve seen some companies thinking that a meeting will solve all issues, and FDA will be persuaded that everything is fine and the drug should be approved,” Cavazzoni said, adding that the reality is generally far from that.
The agency has continually dealt with issues around data integrity, which has led to warning letters citing things like bags of shredded documents.
“Get away from paper,” Cavazzoni said, emphasizing the value of digital audit trails. “Even if you shred a laptop,” the data will still be there, she said.
