RFK Jr.’s Muddled Claims on Drug Approval Speed

The Food and Drug Administration successful caller months has approved a tiny fig of drugs rather rapidly nether a caller expedited reappraisal program. But Health and Human Services Secretary Robert F. Kennedy Jr. has overstated the interaction of the programme by making misleading comparisons to the gait of cause approvals successful the past.

“We conscionable approved 2 caller drugs, 2 caller oncology drugs, successful grounds time, 1 successful 45 days,” Kennedy said astatine an April 16 legislature hearing, adding that the different was approved successful 55 days. “The closest earlier that was 310 days.” At different proceeding that aforesaid day, helium called the 2 approvals the “fastest successful history.”

The crab drugs weren’t wholly caller drugs. Instead, the FDA approved an expanded use, oregon indication, for a previously approved drug and a caller combination of antecedently approved drugs, reviewing the drugs 44 and 55 days aft filing, according to FDA quality releases. Meanwhile, Kennedy’s 310-days fig is the mean caller cause exertion reappraisal clip for 2025, according to April 1 remarks by now-former FDA Commissioner Dr. Marty Makary.

Dr. Aaron Kesselheim, who studies the regularisation of drugs astatine Harvard Medical School and Brigham and Women’s Hospital, told america that comparing the accelerated caller oncology approvals to an mean for each drugs is similar “comparing apples and gorillas.” The caller oncology approvals would person been easier to reappraisal to statesman with since they were for caller indications, helium said, adjacent without the FDA’s caller expedited program.

Nor is it unprecedented for the bureau to o.k. definite drugs much quickly, oregon acold much quickly, than the average.

The FDA announced the Commissioner’s National Priority Voucher aviator programme successful June 2025, the latest successful a agelong enactment of efforts implicit decades to expedite approvals of definite drugs. The CNPV programme says it aims to “dramatically trim reappraisal times” for drugs that conscionable nationalist wellness priorities, with people reappraisal times of 1 to 2 months. Seven drugs person so far completed reappraisal done the program.

Makary, who resigned from his presumption connected May 12, has made akin claims. In a May 5 interview with CNBC, Makary said that the FDA “got those decisions retired successful 44 days and 55 days alternatively of a year,” for example.

It’s a “little spot soon to evaluate” the wide interaction of existent policies connected cause support speeds, Kesselheim said, fixed the “relatively small” fig of drugs that person been reviewed wholly nether the ticker of the caller administration. “There’s nary grounds that there’s been immoderate large alteration yet successful this administration,” helium said.

Kennedy was besides incorrect to accidental that the oncology drugs were approved “in grounds time.” Makary acknowledged an adjacent faster approval of an HIV cause successful the 1990s. (However, the FDA later, connected May 8, approved a caller denotation for a 3rd crab drug even much quickly, tying the erstwhile grounds Makary mentioned.)

The HHS caput further claimed the fig of caller and generic cause approvals nether the Trump medication successful 2025 were each a “record.” But accusation connected the FDA’s website contradicts that. The bureau didn’t reply to our questions astir these claims.

‘Comparing Apples and Gorillas’

As we said, Kennedy’s and Makary’s comparisons of the caller oncology cause approvals with erstwhile reappraisal times of 10 months to a twelvemonth are misleading.

The 44-day oncology reappraisal Kennedy has promoted was of zongertinib, a cause primitively approved successful 2025 to dainty a subset of patients with precocious lung cancer. In February 2026, the bureau expanded the radical of patients for whom the cause was approved to see those who had not received anterior treatment.

“Zongertinib was an enlargement of an already-approved indication, which is wholly extracurricular of what we are talking astir successful presumption of mean reappraisal times,” Kesselheim said. This is “an already-approved cause with a known efficacy for a definite indication, a known information profile,” helium continued. “The shaper is submitting a small spot much grounds to enactment a statement enlargement to a precise intimately connected indication.” 

Studies person agelong shown that supplemental indications instrumentality a shorter time to review than applications submitted for drugs that person ne'er been approved before.

After a drugmaker submits an exertion to the FDA, the bureau has 60 days to reappraisal the exertion and determine whether to “file” it. Using the FDA’s website, we’re capable to spot the clip from a drugmaker’s submission to FDA approval, arsenic this is the accusation successful the agency’s support letters.

Kennedy’s and Makary’s figures, however, measurement cause reappraisal times from erstwhile the FDA files the application, according to FDA property releases.  

The CNPV programme aims to get much materials from cause companies during a 60-day presubmission play and to shorten the 60-day filing period, including by utilizing artificial intelligence-based tools. The extremity is to reappraisal drugs wrong astir 1 to 2 months aft the FDA files the application, with a anticipation to widen the timeline.

“The required pre-submissions and extensions marque these reviews feasible, but they besides implicitly admit that existent 30 to 60–day reviews are unlikely,” Ryan Conrad, an economist and visiting chap astatine the Brookings Institution, wrote successful an October commentary. “While these reviews volition instrumentality longer than advertised, they are designed to beryllium faster than existing timelines,” helium added.

For zongertinib, the FDA spent 235 days — oregon a small nether 8 months — reviewing the drug’s archetypal application, from the clip it was submitted. The FDA past spent a full of 104 days reviewing the exertion for zongertinib’s expanded indication, which includes the 60-day filing play positive the 44 days it took the FDA to reappraisal the exertion aft filing it.

The different oncology approval, whose 55-day reappraisal from filing Kennedy and Makary promoted, was for Tec-Dara, a operation of drugs approved to dainty the humor crab aggregate myeloma. The cause was approved 90 days aft submission. However, the 2 drugs making up the operation had antecedently been approved to treat the aforesaid crab type. This benignant of support “does not necessitate the aforesaid benignant of start-from-scratch reappraisal that a caller cause that had ne'er been connected the marketplace earlier we would expect to beryllium taxable to,” Kesselheim said.

Kennedy compared these approvals to an mean 310-day cause reappraisal clip successful 2025, a fig Makary had cited. We recovered that fig to beryllium plausible. We calculated an mean of astir 366 days from the clip of submission to support for caller cause applications, the benignant of exertion Makary’s presentation mentioned. This is astir successful keeping with Makary’s estimate, assuming that his fig does not see the FDA filing play of up to 60 days.

The latest CNPV approval, connected May 8, was again for an expanded denotation for a crab cause targeted to tumors with a peculiar familial mutation. The drug, zenocutuzumab, was approved for patients with a uncommon bile duct cancer, expanded from a anterior support for patients with lung and pancreatic crab with the aforesaid mutation.

As for the different drugs frankincense acold approved nether the CNPV program, galore had immoderate further characteristics that whitethorn person sped up their approvals regardless. 

For example, the FDA successful an April 1 press release promoted the support of orforglipron, a caller oral GLP-1 for value loss, successful 50 days from filing, oregon 71 days from submission. These drugs “have been astir for 2 decades aft being discovered based connected publically funded probe successful the 1980s and 1990s,” Kesselheim said. “So that’s different illustration of a cause people with a agelong way grounds for which this is simply a caller formulation.” The bureau besides approved a higher dose of a antecedently approved GLP-1 drug.

The CNPV program’s archetypal action successful December 2025 had been to bring backmost an antibiotic, Augmentin XR, whose brand-name mentation had gone off the market. The cause is simply a “many decades aged merchandise that is wide disposable arsenic a generic,” Kesselheim said, explaining that specified applications necessitate “far little information than caller cause applications do.”

Sorting Out Claims of Record Approvals

Kennedy besides claimed the medication was mounting records for the fig of drugs approved, but we recovered accusation that contradicts that.

“We person breached each grounds for cause approvals,” helium said during the April 16 legislature hearing, a assertion helium repeated astatine an April 21 hearing. “We approved 67 drugs this year, caller drugs,” helium said, calling this a record. “We approved 91 caller generic drugs, which is simply a record,” helium continued. HHS societal media accounts besides shared these claims.

Kennedy’s 67 fig matches the fig of medications and definite different products approved successful 2025 by the FDA’s drugs and biologics divisions, erstwhile added together. However, erstwhile adding up the equivalent approvals from 2024, we recovered that the bureau had approved 69 products. Kennedy’s assertion of a grounds 91 generic approvals again matches the fig of 2025 approvals for first-time generics. But arsenic precocious arsenic 2022, determination were 107 specified approvals.

Makary, by contrast, called the 67 approvals a “near record” successful his presentation to FDA unit and again during his May 5 CNBC interview. A report from the FDA connected a subset of drugs and biologics approved by the Center for Drug Evaluation and Research recovered the fig of approvals successful 2025 was “similar to the mean for the past 5 years.”

As for the cause reappraisal speeds, Kennedy touted the reviews of the expanded oncology indications arsenic records, portion Makary said the 44- and 55-day reviews came near the record-breaking support of an HIV drug. The 42 days it took to approve the HIV drug, Crixivan, successful 1996 was from submission to approval, however, portion the HHS officials counted from a aboriginal milestone for the 2 caller oncology approvals, arsenic we explained.

From submission to approval, the caller oncology reviews took 104 and 90 days.

Long History of Expedited Review

In the 1980s, the FDA had debased backing and average drug review times of 2 to 3 years, Kesselheim explained. In 1992, Congress passed the Prescription Drug User Fee Act, which required companies applying for cause support to pay a user fee, allowing the FDA to prosecute much staff. The instrumentality besides acceptable a modular reappraisal deadline of 12 months and yet 10 months from filing, and it created precedence reappraisal presumption for definite drugs, which had a reappraisal deadline of six months.

“Very rapidly aft that, reappraisal times fell,” Kesselheim said.

Expedited FDA reappraisal programs person accumulated implicit time, and determination are presently four main pathways, positive the CNPV pathway and different initiatives aimed astatine shortening review. The programs person been criticized for expanding to see a bulk of drugs, without needfully requiring companies to amusement their drugs person greater therapeutic worth than different options, and for approvals of drugs that aboriginal crook retired to person antecedently chartless information issues oregon to beryllium little effectual than initially thought.

Studies agree that drug review speeds successful the U.S. decreased rapidly successful the precocious 1980s and 1990s, and that reviews successful the U.S. person since been among the fastest successful the world.

A survey by Kesselheim and his colleagues found that reappraisal times “declined from much than 3 years successful 1983 to little than 1 twelvemonth successful 2017.” By 2018, median FDA reappraisal times for drugs successful the modular reappraisal pathway had fallen to a small implicit 10 months, and to 7.6 months for drugs successful the precedence reappraisal program.

Another survey found that median reappraisal clip from submission fell from much than 2 years earlier the transition of PDUFA successful 1992 to a small implicit a twelvemonth implicit the pursuing 2 decades, to nether 10 months successful the decennary aft that.

However, information from the U.K.’s Centre for Innovation successful Regulatory Science showed that FDA reappraisal times from submission inched up successful caller years, reaching a median of more than 11 months from 2022 done 2024.

Regardless of the mean reappraisal time, determination is precedent for the FDA to o.k. immoderate drugs rather quickly. To sanction a fewer oncology examples, the bureau successful 2001 approved Gleevec, a attraction that transformed the prognosis for an often-fatal signifier of leukemia, 72 days aft the drug’s exertion was submitted. It would spell connected to approve 2 different leukemia drugs successful 75 and 78 days.

In the lawsuit of the CNPV program, it is not wholly wide what qualifies a cause for fast reappraisal oregon who makes the selection, according to erstwhile and existent FDA unit and regulatory argumentation experts quoted successful respective quality reports. The medication successful February released immoderate details connected selection, but questions remain.

Vouchers person been awarded after drugmakers discussed deals with the Trump medication to little cause prices. Last month, the FDA besides added 3 psychedelics to the programme amid a larger effort from the White House to boost the drugs, aft President Donald Trump said that podcaster Joe Rogan and others had talked to him.

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The station RFK Jr.’s Muddled Claims connected Drug Approval Speed appeared archetypal connected FactCheck.org.