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Enforcement Comeback? FDA Budget Predicts Eye-Popping 1,767% Increase In US Inspections In FY ’22

Enforcement Comeback? FDA Budget Predicts Eye-Popping 1,767% Increase In US Inspections In FY ’22

Source : Medtech Insight

A budget request for the US Food and Drug Administration released by the White House on 28 May predicts that domestic GMP inspections of device makers will increase by a whopping 1,767% in fiscal year 2022.

The FDA estimates it will conduct only 75 inspections in the current fiscal year, which ends on September 30. But in FY ’22 – October 2021 to September 2022 – the agency says it wants to perform 1,400.

While that’s a massive increase in the number of inspections, bear in mind that the FDA is merely returning to pre-pandemic figures. To wit: The agency estimated it would carry out 1,400 inspections in its FY 2019 budget request. (A total of 622 inspections were conducted in FY 2020, when the pandemic began.)

The figures found in the budget request are a strong indication that the FDA believes it’s ready to send its inspectorate back into the field beginning this October, and that the COVID-19 pandemic could be in its waning days. The agency documented its anemic inspection tally for fiscal ’21 in a 5 May report. ("At Best FDA Will Carry Out Only Half Of Domestic Surveillance Inspections In FY 2021 Report Says" "Medtech Insight" )

The FDA has been performing Remote Regulatory Assessments of domestic device firms during the pandemic in lieu of in-person inspections. ("From Electronic Docs To FOIA Requests FDA Lays Bare Its Process For Remote Regulatory Assessments" "Medtech Insight" )

Foreign device manufacturers will also see more investigators in FY ’22 if the budget passes. The FDA estimates it’ll conduct 550 GMP inspections of OUS firms, up an astonishing 10,900% from fiscal 2021. The agency estimates that a mere five foreign companies will have been inspected by the end of FY ’21.

The budget request asks for an increase of $18.8m to pay for FY ’22 inspections of manufacturers of all commodities the FDA oversees.

The agency says the money will be used by the Office of Regulatory Affairs “to address inspections delayed by the pandemic and to increase the level of response for COVID-19 medical countermeasures, food facilities, and counterfeit and misbranded products.”

The ORA conducts all of the FDA’s field activities.

“Without this increase, ORA cannot fully support our medical products programs which regulate the industry ensuring safe and effective products for American consumers,” the agency says. “Without additional resources, there is a risk of needing to lessen frequency of inspections at domestic and foreign manufacturers that supply their products to US consumers.”

By Shawn M. Schmitt