Congressional inaction would leave FDA's drug and biologics evaluation with limited capacity to function.
Thousands of employees at the Food and Drug Administration are facing layoffs or furloughs if Congress does not take action by the end of the month, though lawmakers remain divided on how to move forward.
FDA’s authorization to collect user fees from pharmaceutical companies, medical device manufacturers and other entities, which fund the agency’s inspections and oversight of medical products, is set to expire Sept. 30. Without reauthorization, which must occur every five years, FDA officials have warned that employees whose salaries are funded by the fees could face reductions in force or furloughs. The House has passed bipartisan legislation to address the situation and the Senate has moved a similar bill, but late disagreements have held up final passage.
In a message to employees last month, FDA Commissioner Robert Califf said congressional inaction would spark a “notification process” for impacted staff. He said that personnel in the prescription drug program would be the first to feel the strain of the funding crisis, though it may be able to stay afloat with carryover funds for up to five weeks past the deadline. Califf said he has been meeting with congressional staff to stress the urgency of action, though he noted his office is exploring “all potential options and scenarios” if lawmakers fail to pass the required legislation.
“The resources provided also include direct funding for many staff positions across the agency,” Califf said. “Therefore, the timely reauthorization of this law is of critical importance.”
Absent congressional action, Chanapa Tantibanchachai, an FDA spokesperson, said the agency plans to begin notifying employees funded through the Prescription Drug User Fee Act of “impending employment actions” later this month. Those would go out to 3,500 employees. If the employees are forced to not report to work, FDA’s Center for Drug Evaluation and Research would be left with fewer than 1,000 employees and its Center for Biologics Evaluation and Research with about half of that total. Other programs would subsequently run out of money at varying intervals, depending on how long the situation dragged on. FDA would continue to accept applications to review products, though it would no longer guarantee any specific turnaround time.
A delay would impact not just workers but key mission activities, including efforts related to COVID-19 vaccines and therapeutics, monitoring the safety of marketed products, oversight of clinical trials and reviews of applications for treatments for rare diseases that have unmet medical needs. Califf previously said even the threat of furloughing employees would damage ongoing, critical hiring efforts.
Tantibanchachai said FDA “at this time” has a “reasonable expectation” that positions supported through the user fees will be funded, though she noted she could not offer details.
“FDA’s obligations to communicate with our staff about employment actions hinge on the expiration of funding for positions financed through user fees,” she said. “We will continue to evaluate the situation.”
The House passed a reauthorization bill (H.R. 7667) in June in an overwhelmingly bipartisan vote. The Senate Health, Education, Labor and Pensions Committee put forward a similar bill with support from both Sen. Patty Murray, D-Wash, the panel’s chair, and Sen. Richard Burr, R-N.C., its ranking member, but Burr subsequently withdrew his support over new policy riders tacked onto the measure. The bill would allow FDA to provide stricter oversight of cosmetics and dietary supplements, and would create diversity standards for clinical trials. While the committee approved the bill, Burr has introduced a “clean” version that strips the measure of those provisions.
Burr said his bill "represents the clearest path forward" and lambasted Democrats for their version—which passed the committee with bipartisan support—that would "compromise the FDA's overall ability to keep pace with advancements in the industry it regulates."
The senator said his legislation, meanwhile, “keeps FDA’s critical operations running, protects existing scientific experts and ongoing hiring activities at the agency, and ensures the agency can continue to review new medical products, while encouraging private sector investment in the next generation of developments.”
The Senate came back into session on Tuesday after a month-long recess, but a solution to the looming crisis has yet to emerge. Murray last month pushed back on Burr's claims, saying her bill would keep families safe, spur innovation and ensure that more types of products are safe when they hit the market. She added the measure would protect the FDA workforce.
“Pink slips are unacceptable to me, and they should be unacceptable to all of us—that is why it makes absolutely no sense to back out of bipartisan negotiations now,” Murray said. “The fastest way to get this done is to move forward with the comprehensive bipartisan bill we have already advanced out of committee, and which includes so many desperately needed, long overdue, and bipartisan policies.”
The senators are facing bipartisan pressure from their counterparts in the House to act quickly to avoid devastating impacts to FDA employees.
“Unless the Senate acts urgently to meet its deadline, FDA will be forced to issue reduction-in-force notices and furlough thousands of workers who ensure the safety and efficacy of medical products," Reps. Frank Pallone, D-N.J., and Cathy McMorris Rodgers, R-Wash., said in a joint statement in July. They encouraged the upper chamber to act on the bill the House already passed with little resistance.
While Murray, Pallone and McMorris Rodgers referred to layoffs, Tantibanchachai, the FDA spokesperson, declined to clarify whether an authorization lapse would result in furloughs or RIFs. A spokesperson for committee Democrats on Tuesday expressed confidence that lawmakers will, ultimately, take action.
“Congress will not allow FDA user fees to expire,” the spokesperson said. “They are a top priority for Chairman Pallone and he is determined to reach an agreement and see it passed and signed into law in the coming weeks.”
Compressing the congressional schedule, lawmakers must also act by the end of the month to pass a stopgap spending bill to fund all of government. FDA employees are typically shielded from shutdown-related furloughs due to the nature of their funding and work, but much of the rest of government could force its employees to stay home if Congress fails to pass a spending bill.