ORA chief says funding needed to keep pace with growing inspectional inventory

The US Food and Drug Administration (FDA) will not be able to keep up with its growing inspection inventory if it does get additional funding from Congress in its FY 2025 budget, said Michael Rogers, associate commissioner for regulatory affairs at the US Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA).

Rogers made these remarks during a webinar sponsored by the Alliance for a Stronger FDA on 1 May. Without the increase, “our attrition rate and our ability to retain our staff and the cost of absorbing the cost-of-living increase will impact our ability to provide the level of oversight that we have historically provided.” In other areas, he noted that the reorganization of ORA will go into effect in 2025, one year later than originally planned.

Over the past 10 years, there has been “significant growth” in the food budget, yet there has been a more limited increase in his office’s medical product budget, Rogers said. Unlike the agency’s medical product centers, 90% of ORA’s budget comes from budget authority and only 10% from user fees, so ORA is highly dependent on the appropriations process.

For FY 2025, ORA is requesting an additional $2.7 million and ten FTE for shortages and the supply chain. The additional funding will allow ORA to keep pace with the growing number of medical devices and biologics facilities globally and the need to hire investigators to inspect these facilities. FDA is also requesting an additional $46 million for annual cost of living increase in FY 2025.

Without the additional money, FDA will have to take $30 million out of its operating budget to cover the spread, and less money will be available to hire inspectors, thus reducing the number of inspections.

Rogers lamented that “we have got to invest in our most important resources, our investigators and the people wo support them. They have been underrecognized and underappreciated and we have got to compensate our front-line investigators so that they want to stay.”

At an Alliance webinar in April, FDA officials said a nearly 5% increase is needed to provide its staff with pay increases to offset inflation, and that the lack of such increases in the current budget had a detrimental impact on the agency’s public health mission. (RELATED: FDA officials say FY 2025 budget increase needed to offset inflationary pay increases, Regulatory Focus 16 April)

Another challenge cited by Rogers is the loss of experienced investigators through retirements. “There is a significant amount lost when we lose a senior investigator, they provide the training and the more difficult work. We are now facing the challenges of attrition.”

‘Excitement’ in new name

Rogers discussed the agency’s plans to reform its human foods program and rebrand ORA as the Office of Inspections and Investigations (OII). He said the reorganization will go into effect “sometime in 2025” a year later than originally projected. (RELATED: FDA leaders detail reorg plans, say 1,500 ORA staff will be reassigned, Regulatory Focus 19 January 2024)

OII’s name was derived from an internal crowdsourcing campaign. Rogers said that “OII surfaced to the top. OII is a name that stands on its own,” and added that “there is a level of excitement about this new name. We will focus on the ‘three I’s,’ inspections, investigations and import operations.”

This is the largest reorganization in FDA’s history and will impact about 8,000 employees.

ORA chief says funding needed to keep pace with growing inspectional inventory

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