The U.S. Food and Drug Administration is adopting a strategy long used in the private sector to increase productivity: paying employees to move faster.
FDA Commissioner Marty Makary announced last week that the federal agency will begin offering performance-based cash bonuses to staff who complete drug reviews ahead of schedule. The pilot program, dubbed the “Reviewer Recognition and Excellence” program, involved “some wrangling” by the commissioner, who apparently told FDA staffers as much, according to the Associated Press.
“My job as your commissioner is to be your advocate and to fight for you,” Makary told staffers during a meeting in late February, the AP reported. “If you don’t like it, we can get rid of it, but usually everybody loves money.”
The FDA has lost about 20% of its employees since President Donald Trump began his second term last year. For the agency, the bonuses might also offer another incentive for employees to stay.
The pilot program is intended to address growing bottlenecks in the pharmaceutical approval process by speeding up summaries and information gathering—all while maintaining, the FDA insists, the same level of scientific reviews as before.
The FDA told Fortune in a statement that it’s a pilot program which “advances the Commissioner’s goal of improving efficiency while fully maintaining FDA’s rigorous scientific standards and requirements.” The program intends to reward review staff “for efficiency and excellence,” but it won’t change review criteria, evidentiary thresholds, or quality safeguards.
The FDA was sure to reiterate that those scientific guardrails will remain in place during the pilot program, which is set to begin issuing quarterly payments as soon as this coming August.
“FDA reviewers will continue to apply the same gold-standard scientific integrity and independence to every application without compromising patient safety and public health,” the FDA spokesperson said.
D.A.R.E. to approve?
The move comes as the agency enters a new era of drug development applications, driven by health-inspired medicines, following the influx of health-focused companies following the COVID-19 pandemic and the surge of venture capital flooding the biotech industry. According to FDA data ranging from 1938 to 2022, the clinical research pipeline is now roughly 30% to 60% larger than what the agency had to go through in the 1990s. In addition to increased VC health funding, some factors driving this uptick include new gene therapies, academic spinouts, precision medicine, and immunotherapy. In essence, the ideas are endless, and the FDA needs to test them all.
With the influx of “new drug applications” taking up a larger percentage of labor hours, the FDA had to turn to some other alternatives for help. The agency already has a program in place from the 1990s, called the Prescription Drug User Fee Act (PDUFA), which outlines the guidelines and metrics for the FDA to review a drug. Drug companies pay significant fees to the agency when submitting their applications, which now totals more than $2.8 trillion for trials involving clinical data.
The PDUFA also allows drug companies to pay additional, voluntary fees to the agency to help pay for additional staffers—a move that has seen some positive benefits in an expedited review process. Although the FDA has an agreement in place with titans of the industry outlining metrics and timelines of such a process, those companies—and the FDA itself—have never directly paid staffers for meeting or exceeding timelines, until now.
The bonuses are to “recognize and reward staff who find ways to be more efficient delivering high-quality work activities that ultimately benefit patients,” according to a slide presented to staffers during the announcement, the AP reported. At one point in time, an official for the agency told agency employees—and, important to note, only drug reviewers will be eligible for the bonus—that they would be paid based on quantifiable “weighted time savings” in addition to “work quality and work complexity.”
The FDA goes through its experimental AI phase
Before PDUFA was passed, the drug approval process was notoriously slow. The average drug would take between 21 and 29 months to be reviewed. Now, the FDA’s target is between six to 10 months.
One of the ways the agency is looking to expedite the process even more is with the use of generative AI, which the agency has lovingly called their version, Elsa.
“The FDA’s internal AI tool, Elsa … can assist with synthesizing and summarizing information, refining communication, outlining content, drafting, proofreading, and basic coding tasks,” the FDA told Fortune in a statement, adding that Elsa is used to help with administrative and daily activities.
“For example, when conducting a review on a new industry submission, Elsa could automatically integrate data from multiple FDA databases, identify relevant regulatory precedents, search for related regulatory history, and collect information to inform a draft review,” an agency spokesperson continued. “The FDA has received tremendous accolades from staff who say that Elsa is reducing administrative burden and improving efficiency.”
The agency launched the gen AI model in June 2025 to help meet its aggressive new timelines. However, experts say these kind of things, like financial incentives and the use of AI raise concerns about the agency trading public health for better stats.
Dr. Michael Carome, Public Citizen’s Health Research Group Director, said as much when asked about this a few years ago regarding the agency’s bungled, in his view, review of the Alzheimer’s drug Aduhelm, which he said showed the agency’s “stunning disregard for science.”
“The FDA has lowered standards for approving drugs like this,” he said at the time. “And other companies are going to take advantage of that.”
Carome’s comments occurred after the FDA approved the drug, even after the agency’s advisory committee—an independent group of outside scientists—voted unanimously they did not find evidence the drug worked, and even after the drug went through two Phase III trials, only to show failed, mixed, and controversial results.
It “dangerously compromised the integrity of the agency’s review.”
