FDA to Offer Bonuses for Faster Drug Reviews – Safety Concerns Rise

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FDA to Offer Bonuses to Drug Reviewers Amid Staffing Concerns and Push for Faster Approvals

WASHINGTON (AP) — The Food and Drug Administration (FDA) plans to implement a pilot program offering bonus payments to agency drug reviewers who complete their work ahead of schedule. This initiative, announced by FDA Commissioner Marty Makary, represents the latest in a series of changes aimed at streamlining longstanding norms and procedures within the agency.

Bonus Program Details

The first quarterly bonus payments are expected to be distributed to eligible employees around August. According to slides and a recording of a staff presentation obtained by the Associated Press, Commissioner Makary emphasized his commitment to advocating for FDA staff, stating that securing approval for the payments required “some wrangling.” He expressed confidence that the program would be well-received, noting, “usually everybody loves money.”

The program intends “to recognize and reward staff who find ways to be more efficient delivering high-quality work activities that ultimately benefit patients,” according to presentation slides. Payments will be based on “weighted time savings” achieved by employees and their teams, as well as ratings-based “work quality and work complexity.”

The FDA assures that the program will prioritize speed without compromising quality, stating, “This program values speed, but never at the expense of quality.”

Context: Staffing and Approval Timelines

The announcement comes as the FDA faces challenges related to staffing levels. The agency has experienced losses in drug review staff due to retirements and resignations following broader layoffs and buyouts. Agency records indicate that the FDA’s drug and biologics centers have lost approximately 20% of their employees since President Donald Trump took office in 2017. CNN

some agency reviewers are actively interviewing for positions within the pharmaceutical industry, potentially impacting their ability to focus on current projects.

Historical Funding and Current Initiatives

Since the 1990s, the FDA has collected user fees from drug companies to fund additional staff and expedite the review of novel prescription drugs and vaccines. These fees come with established timelines and metrics for review completion. However, the agency has not previously offered direct payments to employees for meeting or exceeding these goals.

Commissioner Makary, who was confirmed by the Senate in March 2025, HHS.gov has announced several measures aimed at shortening FDA reviews since assuming his role last April. These include offering one-month drug assessments for medications deemed to be of “national interest,” and establishing a new pathway for therapies that can only be tested in a limited number of patients. CNN

In August 2025, Commissioner Makary announced that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, had officially ended, marking a significant milestone for public health. FDA

Potential Concerns and Oversight

The bonus program raises potential ethical considerations, as FDA reviewers could be perceived as being incentivized to rush the process of confirming drug safety and effectiveness. The program could also impact public perception of the FDA, which has sometimes been viewed as too closely aligned with the drug companies it regulates.

Health Secretary Robert F. Kennedy Jr. Has publicly expressed concerns about the FDA’s relationship with the pharmaceutical industry, describing FDA staffers as “a sock puppet” of industry. CNN

Approximately 70% of the FDA’s drug program is financed by user-fee payments from drug companies submitting their products for review. This arrangement has enabled the agency to hire additional scientists and significantly reduce review times.

Recent Actions by Chief Scientist

Dr. Vinay Prasad, the FDA’s chief scientist and vaccine director, has recently overruled staff decisions to reject several experimental therapies and biotech drugs, citing the require for further studies and more conclusive evidence. He initially refused to accept Moderna’s application for a new mRNA flu shot, deeming its clinical trial insufficient, but the agency later reversed course after Moderna agreed to conduct an additional study in older adults.

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