WASHINGTON — Food and Drug Administration Commissioner Marty Makary has announced plans to implement a new pilot program providing financial bonuses to agency staff members who finish drug evaluations before their deadlines.
During a Thursday staff meeting, Makary outlined the initiative that would begin distributing quarterly bonus payments to eligible employees starting around August. The Associated Press obtained presentation materials and audio from the meeting.
“My job as your commissioner is to be your advocate and to fight for you,” Makary stated to FDA personnel, noting that securing approval for the payment system required “some wrangling.”
“If you don’t like it, we can get rid of it, but usually everybody loves money,” Makary added.
The new system creates several concerns, particularly regarding how payments will be allocated among the large teams that typically work together on drug evaluations. Workers not directly involved in drug reviews, including facility inspectors, won’t qualify for these payments. The program also raises ethical questions about whether reviewers might feel pressured to accelerate processes crucial for verifying medication safety and efficacy.
For decades, the FDA has collected fees from pharmaceutical companies to fund additional personnel for expedited reviews of new prescription medications and vaccines. While the agency operates under industry agreements with specific timelines and performance measures for completing reviews, it has never previously provided direct financial incentives to workers for meeting or surpassing these targets.
According to presentation materials shown to FDA staff, the bonus system is designed “to recognize and reward staff who find ways to be more efficient delivering high-quality work activities that ultimately benefit patients.”
Senior agency officials explained during the meeting that payments would be calculated using “weighted time savings” accomplished by employees and their teams, combined with assessments of “work quality and work complexity.”
“This program values speed, but never at the expense of quality,” according to one presentation slide.
This announcement comes during a period when the agency is experiencing significant staffing losses in its drug review divisions due to retirements and departures following broader workforce reductions and buyout offers across other agency departments. FDA records indicate that the drug and biologics centers responsible for overseeing prescription drugs, vaccines, and biotechnology products have lost approximately 20% of their workforce since President Donald Trump assumed office one year ago.
Furthermore, some agency reviewers are unable to participate in certain projects because they are currently interviewing for positions within the pharmaceutical industry.
The initiative could also harm public trust in the FDA, which has frequently faced criticism for being too closely connected to the drug companies it regulates.
Health Secretary Robert F. Kennedy Jr., who supervises the agency, has characterized FDA staff as “a sock puppet” of industry since taking his position as the nation’s leading health official last February.
Approximately 70% of the FDA’s drug program funding comes from user fees paid by pharmaceutical companies submitting products for review. This arrangement has enabled the agency to employ thousands of additional scientists and reduce review timeframes by more than half compared to pre-funding levels.
Since joining the agency last April, Makary has introduced several initiatives aimed at accelerating FDA reviews, including providing one-month drug evaluations for new medications serving “national interests.” Within just the past two weeks, Makary announced the FDA would eliminate its long-standing requirement for two clinical trials in drug reviews and establish a new approval pathway for treatments that can only be tested in limited patient populations.
These announcements promoting accelerated, simplified approvals occur as the agency faces scrutiny regarding its recent management of vaccines, gene therapies, and other specialized treatments.
The FDA’s chief scientist and vaccine director, Dr. Vinay Prasad, has personally overturned staff decisions by rejecting multiple experimental therapies and biotech drugs, citing requirements for additional research and more conclusive evidence.
Earlier this month, Prasad declined to accept Moderna’s application for a new mRNA influenza vaccine, stating its clinical trial was inadequate. However, less than a week later, the agency changed its position, agreeing to review the vaccine after Moderna committed to conducting an additional study involving older patients.
