White House warns over lackluster FDA funding increase in incoming appropriations bill

The White House said Wednesday that it “strongly supports” a Senate appropriations bill that’s making its way through Congress this week and would include the FDA’s funds for the next fiscal year.

But the Biden administration also said Wednesday morning that at the funding level specified for FDA, the agency would need to do some serious juggling of its books to maintain its current staff levels.

Biden’s team notes an increase of only about $20 million for the FDA through the end of September 2024, as per the Senate bill text, adding:

The Administration does have some concerns that at that level, FDA would need to absorb the statutorily required pay increase for staff. In order to maintain current FDA staff and service levels, this would require FDA to take funding from other programs to meet the need.

The Biden administration noted that this funding crunch would also impact FDA’s ability to maintain current levels of medical product reviews.

“The Administration would like to work with the Congress to ensure that there is sufficient funding to support the staff necessary to allow FDA to meet its core public health mission to keep food safe and ensure medical products are safe and effective,” the White House’s Office of Management and Budget said in a statement.

Hiring and retention of staff have been major issues for the FDA, particularly as those with expertise in pharma and biotech can quickly move over to the industry and earn double or triple what they make at the federal agency.

But things have improved in the near term. Back in April, CDER Director Patrizia Cavazzoni said in an Alliance for a Stronger FDA webinar that the drug center at FDA hired more than 270 staff and lost 150 staff over the last year (a net gain of 120 staff) as of February, which compares with about 140 additions and 180 lost staff last year (a net loss of 40 staff).

Judy McMeekin

The FDA has particularly struggled in hiring new pharma manufacturing and other inspectors as the agency is losing inspectors more quickly than it’s able to bring on new hires, said Judy McMeekin, the retired associate commissioner for regulatory affairs in the FDA’s Office of Regulatory Affairs.

“Sometimes they have to extend their foreign trip when an issue arises, and we need to get someone in the facility quickly. So instead of coming home, they may have to go from India to Korea with just a few days to prepare. So obviously one of our biggest challenges and a major priority for our ORA is hiring new investigators and retaining them,” McMeekin said.

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