US FDA Brings Back Furloughed Workers To Inspect High-Risk Facilities

Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

The US FDA has brought 400 inspectors and support personnel off furlough to conduct surveillance inspections of high-risk facilities during the partial federal government shutdown that began Dec. 22, FDA Commissioner Scott Gottlieb said in a Jan. 15 tweet.

The workers, who will remain unpaid while the government is shut down, include about 70 who will focus on inspections of high-risk drug manufacturing facilities and about 90 who will focus on inspections of high-risk biological manufacturing facilities, Gottlieb said.

Gottlieb Jan. 14 described the workers returning from furlough without pay as “among the finest, most dedicated professionals in our federal workforce and we’re grateful for their service.”

Gottlieb earlier announced plans to allow unpaid workers to at least bill inspection-related travel expenses to a central account rather than their own government-issued credit cards. (Also see "Shutdown Week Three: Sponsors With Upcoming User Fee Dates Should Start Sweating " - Pink Sheet, 7 Jan, 2019.)

Travel expenses associated with high-risk surveillance inspections could be high, however, given that many of the facilities that have compliance issues are located abroad.

During the shutdown, the agency has been shifting some carryover user fee funds from application-related activities to public safety-related activities such as oversight of marketed products.

Gottlieb said Jan. 14 the slower “burn rate” that resulted from sharply reducing overhead charges in FDA’s drug and biologics centers should stretch the carryover funds for another five weeks, give or take a week.

How FDA Defines High-Risk Facilities

Each year, FDA plans drug manufacturing facility inspections using a risk-based site-selection model that the agency described in a Sept. 5 update to its Manual of Policies and Procedures. (Also see "US FDA's Inspection Decisions To Be Swayed By Facility "History" With Foreign Regulators" - Pink Sheet, 6 Sep, 2018.)

Details about the algorithm used in the selection process remain under wraps, however.

MAPP 5014.1 explains which tasks the Office of Surveillance in FDA’s Center for Drug Evaluation and Research performs and which ones the Office of Regulatory Affairs handles.

For example, the surveillance office produces a list of drug product and drug substance manufacturing sites that are risk-ranked by the site surveillance model, while ORA plans and conducts the inspections.

Risk factors include compliance history, recalls history, inspection history and inherent risk. Sites FDA hasn’t inspected in four years are high priorities. Inspections by capably foreign authorities are considered.

The inherent risk of sterile injectables raises their priority relative to oral solid dosage forms. Other risk factors include drugs with low API load or narrow therapeutic indices.

From the editors of the Gold Sheet