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Hampering the US Food and Drug Administration’s (FDA) ability to hire puts bipartisan priorities at risk, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) wrote in a letter sent Tuesday to the acting director of the Office of Management and Budget (OMB).
The letter comes as President Donald Trump in late January ordered a freeze on all government hiring, which has some exemptions for public health, though it’s unknown how the freeze impacts FDA or user fee funding to hire new employees. FDA had been battling nearly 1,000 staff vacancies prior to the freeze taking effect.
“We respectfully ask that OMB issue additional guidance clarifying whether FDA is subject to the hiring freeze,” Upton and DeGette write.
Citing the need for more FDA staffers with sufficient scientific expertise, the representatives note that staffing issues can lead to delays in generic drug and biosimilar approvals, which can help reduce the burden of high pharmaceutical and biologic costs.
Champions of the new 21st Century Cures law, DeGette and Upton also note that for the law to be implemented properly, FDA needs to be able to hire additional experts.
“FDA’s ability to carry out numerous new responsibilities under Cures – such as antibiotic approvals, validation of drug development tools, patient-focused drug development, and issuance of new guidance – will depend on the agency’s ability to staff up,” they write.
Upton and DeGette also say they support the idea that user fee funds from industry to hire new FDA employees should be exempt from the hiring freeze, noting that the latest iteration of the Prescription Drug User Fee Act calls for 200 new FDA employees.
“We believe user fee dollars should be available for hiring and their other intended purposes,” they write.
Tags: hiring freeze, FDA employee vacancies, FDA hiring, Upton, DeGette, OMB