Woodcock, Other FDA Officials Offer Regulatory Insights at Annual Industry Meeting

The FDA has resumed routine domestic inspections this month after hitting the pause button for all but mission-critical inspections in March 2020, said Acting Commissioner Janet Woodcock yesterday on day-one of the FDA’s five-day Regulatory Education for Industry Annual Conference.

But the FDA will continue to prioritize foreign inspections based on whether they were “mission-critical,” she said in her keynote address.

The agency faces a pandemic backlog of 8,000 nonmission-critical surveillance inspections, according to a May FDA report (DID, May 6). The agency explained how it could return to a more normal schedule of inspections based on three pandemic scenarios — most likely, best case and worst case.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, also touched on the use of alternative inspection approaches during her presentation and said that these approaches should continue long after the pandemic ends, including the use of remote inspections or mutual recognition agreements with global regulators.

Cavazzoni also stressed that sponsors should engage “early and often” with the FDA when developing COVID-19 therapies, which so far have been cleared by the agency under Emergency Use Authorization (EUA). Only one product — Gilead Sciencies’ remdesivir — has received the agency’s full approval.

In a separate session, Jonathan Resnick, a project manager with the FDA’s Division of Data Management Services and Solutions, congratulated industry on their adoption of  the FDA’s updated electronic submissions portal, making it easier to submit documents and trial data to the agency and expediting the regulatory review process.

In 2020, Resnick said, 85 percent of the 342,000 submissions the agency received came through the Electronic Submissions Gateway (ESG). And as of June 2021, that number was up to 90 percent of 249,000 submissions.

“Reviewing study data in a timely manner is critical for FDA’s review process,” Resnick said, noting that sometimes reviewers will have just 30 days to go over an investigational new drug application. “When sponsors submit data to the FDA in a reliable and accessible format, it improves efficiency and consistency of review decisions.”

But one common technical error continues to plague sponsors, triggering automatic document rejections, Resnick said. From June 2020 to May 2021, CDER rejected 1.4 percent of submissions. The largest portion of these (about one-third) failed because of a duplicate electronic Common Technical Document (eCTD) sequence number.

“CDER will not process a [submission] if the eCTD sequence number already exists,” he said. “This has remained our number-one reason for rejection for the past five years, and unfortunately it’s still at the top.” — Michele G Sullivan and Jason Scott