FDA Expands Inspections as Shutdown Persists

As the partial government shutdown entered a record-setting fourth week, the FDA expanded high-risk inspection activities by bringing back more unpaid staff.

The expanded activities include surveillance and response for serious recalls, and inspection activities beyond “for-cause” inspections, to include foreign and domestic surveillance inspections focused on the highest risk products and facilities.

“Many key functions aren’t getting done. But we’re focused on maintaining core activities that directly impact consumer safety and save lives,” said Commissioner Scott Gottlieb.

Gottlieb announced that approximately 400 staff members would return to their posts, mostly for inspection-related tasks. “About 400 total staff are being engaged in this mobilization,” he said. “The vast majority are inspectors and others are professionals who work in support of inspectors.” Approximately 100 of those will focus on inspections of medical device manufacturing facilities, he said.

Democrats on the Senate Health, Education, Labor and Pensions Committee sent a Jan. 11 letter to Gottlieb calling for details of the shutdown’s impact.

During the shutdown, the FDA is legally prohibited from accepting new submissions that require industry user fee payments, which support the review and approval of applications for medical devices, the lawmakers noted. As a result, the agency “will likely receive a large influx of applications from device makers following the conclusion of the shutdown, requiring the agency to triage review activities and probably causing a backlog in the approval process,” they said.

The letter requests a full overview of the expected spike in application backlogs both currently and for each additional week the shutdown continues, including when the agency expects normal functions to resume.

Read the HELP Committee’s letter here: www.fdanews.com/01-14-19-HELP.pdf. — Zack Budryk