Health Secretary Robert F. Kennedy Jr. touts accelerated FDA oncology approvals under a new expedited review program, but researchers and former regulators say the comparisons may overstate the administration’s achievement.
“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 entirely new. 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-day figure is the average new drug application review time for 2025, according to remarks on April 1 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 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 was 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.”
Studies have long shown that supplemental indications take less time to review than applications 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 can see the time from a drugmaker’s submission to FDA approval, as this information is 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 obtain more materials from drug companies during a 60-day presubmission period and to shorten the 60-day filing period, including through the use of artificial intelligence-based tools. The goal is to review drugs within 1 to 2 months after the FDA files the application, with the possibility of extending the timeline.
“The required pre-submissions and extensions make these reviews feasible, but they also implicitly acknowledge that true 30 to 60–day reviews are unlikely,” Ryan Conrad, an economist and visiting fellow at the Brookings Institution, wrote in an October commentary. “While these reviews will take longer than advertised, they are designed to be faster than existing timelines,” he added.
For zongertinib, the FDA spent 235 days — or a little under eight months — reviewing the drug’s original application, from the time it was submitted. The FDA then spent a total of 104 days reviewing the application for zongertinib’s expanded indication, including the 60-day filing period and the 44 days it took to review the application after filing.
Kennedy compared these approvals to an average 310-day drug review time in 2025, a figure Makary had cited. We found that figure to be plausible. We calculated an average of around 366 days from submission to approval for new drug applications, the type of application mentioned in Makary’s presentation. This is roughly in keeping with Makary’s estimate, assuming that his number does not include the FDA filing period of up to 60 days.
The latest CNPV approval, on May 8, was again for an expanded indication for a cancer drug targeted to tumors with a particular genetic mutation. The drug, zenocutuzumab, was approved for patients with a rare bile duct cancer, expanded from a prior approval for patients with lung and pancreatic cancer with the same mutation.
As for the other drugs thus far approved under the CNPV program, many had some additional characteristics that may have sped up their approvals regardless.
For example, in an April 1 press release, the FDA promoted the approval of orforglipron, a new oral GLP-1 for weight loss, within 50 days of filing, or 71 days from submission. These drugs “have been around for 2 decades after being discovered based on publicly funded research in the 1980s and 1990s,” Kesselheim said. “So that’s another example of a drug class with a long track record for which this is a new formulation.” The agency also approved a higher dose of a previously approved GLP-1 drug.
The CNPV program’s first action in December 2025 was to bring back an antibiotic, Augmentin XR, whose brand-name version had gone off the market. The drug is a “many decades old product that is widely available as a generic,” Kesselheim said, explaining that such applications require “far less data than new drug applications do.”
Sorting Out Claims of Record Approvals
Kennedy also claimed the administration was setting records for the number of drugs approved, but we found information that contradicts that.
“We have broken every record for drug approvals,” he said during the April 16 congressional hearing, a claim he repeated at an April 21 hearing. “We approved 67 drugs this year, new drugs,” he said, calling this a record. “We approved 91 new generic drugs, which is a record,” he continued. HHS social media accounts also shared these claims.
Kennedy’s 67 figure matches the number of medications and certain other products approved in 2025 by the FDA’s drugs and biologics divisions, when added together. However, when adding up the equivalent approvals from 2024, we found that the agency had approved 69 products. Kennedy’s claim of a record 91 generic approvals again matches the number of 2025 approvals for first-time generics. But as recently as 2022, there were 107 such approvals.
Makary, by contrast, called the 67 approvals a “near record” in his presentation to FDA staff and again during his May 5 CNBC interview. A report from the FDA on a subset of drugs and biologics approved by the Center for Drug Evaluation and Research found the number of approvals in 2025 was “similar to the average for the last five years.”
As for drug review speeds, Kennedy touted the reviews of the expanded oncology indications as records, while Makary said the 44- and 55-day reviews came close to the record-breaking approval of an HIV drug. The 42 days it took to approve the HIV drug, Crixivan, in 1996 was from submission to approval; however, the HHS officials counted from a later milestone for the two recent oncology approvals, as we explained.
From submission to approval, the recent oncology reviews took 104 and 90 days.
Long History of Expedited Review
In the 1980s, the FDA had low funding and average drug review times of two to three years, Kesselheim explained. In 1992, Congress passed the Prescription Drug User Fee Act, which required companies applying for drug approval to pay a user fee, allowing the FDA to hire more staff. The law also set a standard review deadline of 12 months, eventually 10 months from filing, and created priority review status for certain drugs, with a review deadline of 6 months.
“Very quickly after that, review times fell,” Kesselheim said.
Expedited FDA review programs have accumulated over time, and there are currently four main pathways, plus the CNPV pathway and other initiatives aimed at shortening review. The programs have been criticized for expanding to include a majority of drugs, without necessarily requiring companies to show their drugs have greater therapeutic value than other options, and for approving drugs that later turn out to have previously unknown safety issues or to be less effective than initially thought.
Studies agree that drug review speeds in the U.S. decreased rapidly in the late 1980s and 1990s, and that reviews in the U.S. have since been among the fastest in the world.
A study by Kesselheim and his colleagues found that review times “declined from more than 3 years in 1983 to less than 1 year in 2017.” By 2018, median FDA review times for drugs in the standard review pathway had fallen to a little over 10 months, and to 7.6 months for drugs in the priority review program.
Another study found that median review time from submission fell from more than two years before the passage of PDUFA in 1992 to a little over a year over the following two decades, to under 10 months in the decade after that.
However, data from the U.K.’s Center for Innovation in Regulatory Science showed that FDA review times from submission inched up in recent years, reaching a median of more than 11 months from 2022 through 2024.
In the case of the CNPV program, it is not entirely clear what qualifies a drug for fast review or who makes the selection, according to former and current FDA staff and regulatory policy experts quoted in several news reports. In February, the administration released some details on the selection process, but questions remain.
Vouchers have been awarded after drugmakers discussed deals with the Trump administration to lower drug prices. Last month, the FDA also added three psychedelics to the program amid a larger effort from the White House to boost the drugs, after President Donald Trump said that podcaster Joe Rogan and others had talked to him.
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-- By Cierra Jacobs
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