FDA to offer bonus payments to staffers who complete speedy drug reviews
WASHINGTON (AP) — President Food and Drug Administration In the latest change to long-standing norms and procedures, the agency plans to begin offering bonus payments to drug reviewers who complete their work ahead of schedule.
FDA Commissioner Marty Makary During a staff presentation Thursday, he described the effort as a pilot program and said the first quarterly bonus payments would begin being distributed to employees around August. The Associated Press obtained slides and a recording of the presentation.
“My job as your commissioner is to be your advocate and fight for you,” Makary told FDA employees, adding that getting approval for the payments required “some wrangling.”
“If you don’t like it, we can get rid of it, but generally everyone loves money,” Makary said.
The plan raises a number of questions, including exactly how payments will be distributed among large teams of staff who often contribute to drug reviews. Employees who are not directly involved in drug inspections, such as factory inspectors, are not eligible to receive payments. The pilot also raises potential ethical dilemmas if FDA reviewers are seen as being rewarded for rushing to take necessary steps. confirming the safety and effectiveness of the drug.
Since the 1990s, the FDA has collected fees from pharmaceutical companies to help pay for extra staff to quickly review new prescription drugs and vaccines. Per agreement with industry, FDA has timelines and metrics for completing each review. But the agency never directly paid workers for meeting or exceeding these goals.
According to slides presented to FDA staff, the purpose of the bonus program is to “recognize and reward staff who find ways to be more productive by providing high-quality work activities that will ultimately benefit patients.”
Senior FDA officials on the call said payments would be based on “weighted time savings” achieved by employees and their teams, as well as “quality of work and complexity of work” based on ratings.
One of the slides states: “This program values speed, but never compromises on quality.”
The announcement comes as the agency loses drug enforcement staff to retirements and resignations following widespread layoffs and buyouts in many other parts of the agency. The FDA’s drug and biologic centers, which oversee prescription drugs, vaccines and biotech drugs, have lost about 20% of their staff since President Donald Trump took office a year ago, agency records show.
Additionally, some agency reviewers are unable to work on certain projects because they are actively interviewing for jobs in the pharmaceutical industry.
The program could also negatively impact public perception of the FDA, which is often seen as too closely tied to the pharmaceutical companies it regulates.
Surgeon General Robert F. Kennedy Jr., who oversees the agency, has described FDA employees as the industry’s “sock puppets” since becoming the nation’s top health official last February.
Approximately 70% of the FDA’s drug program is funded by user fee payments from pharmaceutical companies that submit their products for review. The arrangement allowed the agency to hire thousands of additional scientists and cut review times by more than half than before it received the funding.
Since arriving at the agency last April, Makary has announced a series of measures that he says will shorten FDA reviews. one month medication reviews for new drugs that serve the “national interest.” In the last two weeks alone, Makary has said the FDA would lower its long-held standards. requiring two clinical studies for drug reviews new way For treatments that can only be tested in a handful of patients.
The announcements, which encourage faster and more streamlined approvals, come as the agency has recently faced criticism for its practices regarding vaccines, gene therapies and other specialized treatments.
FDA chief scientist and vaccine director Dr. Vinay Prasad personally rejected the staff’s decision to reject a number of experimental treatments and biotech drugs, citing the need for additional studies and more conclusive evidence.
Prasad at the beginning of this month refused to accept Moderna applied for a new mRNA flu vaccine, saying its clinical trial was insufficient. Then, less than a week later, the agency reverse routeHe said he would review the vaccine after Moderna agreed to conduct an additional study in older people.
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