The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited review program. But Health and Human Services Secretary Robert F. Kennedy Jr. has overstated the impact of the program by making misleading comparisons to the pace of drug approvals in the past.
“We just approved two new drugs, two new oncology drugs, in record time, one in 45 days,” Kennedy said at an April 16 congressional hearing, adding that the other was approved in 55 days. “The closest before that was 310 days.” At another hearing that same day, he called the two approvals the “fastest in history.”
The cancer drugs weren’t completely new drugs. Instead, the FDA approved an expanded use, or indication, for a previously approved drug and a new combination of previously approved drugs, reviewing the drugs 44 and 55 days after filing, according to FDA news releases. Meanwhile, Kennedy’s 310-days figure is the average new drug application review time for 2025, according to April 1 remarks by now-former FDA Commissioner Dr. Marty Makary.
Dr. Aaron Kesselheim , who studies the regulation of drugs at Harvard Medical School and Brigham and Women’s Hospital, told us that comparing the fast recent oncology approvals to an average for all drugs is like “comparing apples and gorillas.” The recent oncology approvals would have been easier to review to begin with since they were for new indications, he said, even without the FDA’s new expedited program.
Nor is it unprecedented for the agency to approve certain drugs more quickly, or far more quickly, than the average.
The FDA announced the Commissioner’s National Priority Voucher pilot program in June 2025, the latest in a long line of efforts over decades to expedite approvals of certain drugs. The CNPV program says it aims to “dramatically reduce review times” for drugs that meet national health priorities, with target review times of one to two months. Seven drugs have so far completed review through the program.
Makary, who resigned from his position on May 12, has made similar claims. In a May 5 interview with CNBC, Makary said that the FDA “got those decisions out in 44 days and 55 days instead of a year,” for example.
It’s a “little bit soon to evaluate” the overall impact of current policies on drug approval speeds, Kesselheim said, given the “relatively small” number of drugs that have been reviewed entirely under the watch of the new administration. “There’s no evidence that there’s been any major change yet in this administration,” he said.
Kennedy was also wrong to say that the oncology drugs were approved “in record time.” Makary acknowledged an even faster approval of an HIV drug in the 1990s. (However, the FDA later, on May 8, approved a new indication for a third cancer drug even more quickly , tying the previous record Makary mentioned.)
The HHS secretary further claimed the number of new and generic drug approvals under the Trump administration in 2025 were each a “record.” But information on the FDA’s website contradicts that. The agency didn’t reply to our questions about these claims.
‘Comparing Apples and Gorillas’
As we said, Kennedy’s and Makary’s comparisons of the recent oncology drug approvals with previous review times of 10 months to a year are misleading.
The 44-day oncology review Kennedy has promoted was of zongertinib, a drug originally approved in 2025 to treat a subset of patients with advanced lung cancer. In February 2026, the agency expanded the group of patients for whom the drug was approved to include those who had not received prior treatment.
“Zongertinib was an expansion of an already-approved indication, which is completely outside of what we are talking about in terms of average review times,” Kesselheim said. This is “an already-approved drug with a known efficacy for a certain indication, a known safety profile,” he continued. “The manufacturer is submitting a little bit more evidence to support a label expansion to a very closely connected indication.”
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Studies have long shown that supplemental indications take a shorter time to review than applications submitted for drugs that have never been approved before.
After a drugmaker submits an application to the FDA, the agency has 60 days to review the application and decide whether to “file” it. Using the FDA’s website, we’re able to see the time from a drugmaker’s submission to FDA approval, as this is the information in the agency’s approval letters.
Kennedy’s and Makary’s figures, however, measure drug review times from when the FDA files the application, according to FDA press releases.
The CNPV program aims to get more materials from drug companies during a 60-day presubmission period and to shorten the 60-day filing period, including by using artificial intelligence-based tools. The goal is to review drugs within around one to two months after the FDA files the application, with…
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