For years, scientists studying aging complained that the US Food and Drug Administration (FDA) had no clear route for a medicine meant to slow aging itself rather than treat one disease. At a longevity conference in Boston on October 1, senior FDA officials said aging and longevity will be one of the topics in the agency’s next report on its science priorities, and they described in some detail how such a drug might one day reach approval12.
Nothing has been approved, and no new rule has been written. But the remarks drew applause in the room, and several outlets present treated them as a notable shift in tone from the regulator123.
What the FDA officials said
The announcement came at the 13th Aging Research and Drug Discovery meeting (ARDD), held October 1 to 3 at Harvard University4. The meeting had been held in Copenhagen in past years and moved to Boston this year2. Four FDA officials sat on a panel called “Matching Clinical Trials of Therapeutics & Regulatory Mandates”1.
FDA Chief Scientist Steven Kozlowski said aging and longevity will be among the topics in an updated Focus Areas of Regulatory Science report, a document that sets out the research questions the agency considers most important for judging medical products1. He described the report as “high-level principles on areas that are very, very important to us; aging and longevity will be one of those topics”2. The previous version came out several years ago2.
Sources differ slightly on timing and naming. GEN reported that Kozlowski said the update would come out early in the US government’s 2027 budget year, which began October 1, without more detail1. A summary published by Insilico Medicine, whose founder started ARDD, called it a “Regulatory Science Priority Areas” document and said its timeline “remains unannounced”4. Business Insider described the FDA as promising new clinical trial guidance next year3.
Lowell Zeta, listed by GEN as acting chief of staff in the FDA commissioner’s office and by Lifespan.io as Deputy Commissioner for Strategic Initiatives, called longevity and healthspan, the years a person lives free of long-term disease or disability, “an important topic for the agency and HHS”12.
“It’s really a defining moment, an inflection point for the future. It’s a test for the future of FDA and how to adapt to the rapidly evolving science in this space.”1
Two possible routes to approval
The panel’s moderator, Andrew Brack, who runs a federal health research program at the agency ARPA-H, asked the officials what the most realistic path would be for a therapy that targets the biology of aging rather than a single disease1.
Jeffrey Siegel, director of the FDA’s Office of Drug Evaluation Sciences, described two ideas1. The first starts from the fact that aging raises the risk of many chronic illnesses, such as some cancers, Parkinson’s, Alzheimer’s and heart disease. “Once you get to two or three that the same mechanism impacts, you begin to think that maybe this general mechanism is having an effect overall on aging-related disorders,” he said1.
The second looks at how aging affects people directly: memory and thinking, frailty, and loss of hearing and vision1. A trial would pick a group of people at risk of that decline and show that it progressed less in those treated than in an untreated comparison group1. Lifespan.io linked this to the idea of “intrinsic capacity,” a combined measure of a person’s physical and mental abilities2.
Justin Penzenstadler, acting associate director of the FDA office covering heart, blood, hormone and kidney drugs, said early trials that could support approval would likely focus on age-related illnesses or death rates, with function tests collected alongside2. He also said his office is responsible for aging as an indication, giving companies a specific place to send proposals2.
Safety, long treatment and the measuring problem
The officials were clear that a broad aging claim needs evidence beyond a drug’s known effects. If a heart drug helps people live longer only through its known heart benefits, that alone does not show it slows aging, Penzenstadler said2. He also flagged the safety math: “We’re thinking about potentially treating somebody for thirty years to derive a couple-year benefit”2. For that reason he favors starting with older, higher-risk people2.
Much of the discussion turned on biomarkers, lab measures such as the blood tests often marketed as “biological age” clocks. Siegel separated tests that predict future risk from tests that can stand in for real outcomes in a trial. “A surrogate endpoint biomarker may also be prognostic, but it has the additional feature that it changes with treatment, and that change reflects the clinical benefit downstream,” he said2. Insilico’s summary described this as an “evidence ladder,” and said tests judged only “reasonably likely” to predict benefit could support accelerated approval, a faster route that requires later confirming trials4.
Kozlowski said it “would be really good to have a shared endpoint [that was] pre-competitive, qualified, and shared broadly so that everybody can use”1. Penzenstadler urged companies to form a joint group to agree on “a cookbook of biomarkers” to collect in trials, so results could be pooled2. “We’re the umpire and not the coach,” he said. “You guys work out the cookbook”3.
What this does not mean yet
These were spoken remarks at a conference. No report, guidance or rule had been published as of the reports, and the officials’ descriptions of approval routes were ideas, not formal requirements12. Being named in a science-priorities report signals that the FDA wants research on a subject; it does not by itself approve anything or lower the bar for evidence.
The measuring problem remains unsolved. Harvard Medical School Dean George Daley opened the meeting with a warning against letting enthusiasm for longevity outrun evidence, GeneOnline reported5. As that outlet noted, a test that makes someone look biologically younger is not proof the person will avoid disease, disability or death5.
Who was in the room
ARDD is organized by Insilico Medicine, an AI drug discovery company whose CEO, Alex Zhavoronkov, founded the meeting in 201454. Executives from Pfizer, GSK, AstraZeneca, Novartis, Eli Lilly and other drugmakers spoke53. Several of these companies have commercial interest in aging as a market; Lilly and Novo Nordisk both presented data at the meeting suggesting their weight-loss drugs slowed lab measures of aging, which Biohack covered in an earlier article3.
The US government was also present beyond the FDA. Brian Christine, Assistant Secretary for Health at the Department of Health and Human Services, argued for trials, real-world data and biomarkers tied to real outcomes5. Brack oversees PROSPR, an ARPA-H program that has committed up to $144 million over five years to seven research teams working on healthspan measures and trials5.
How it fits the field
Lifespan.io noted that the routes Siegel described match efforts already underway: the proposed Targeting Aging with Metformin (TAME) trial would look at several age-related diseases, while XPRIZE Healthspan focuses on muscle, thinking and immune function2. The Biomarkers of Aging Consortium works on shared measures2. The outlet also described growing contact between FDA officials and the longevity field this year, including at a June summit in Washington2.
Business Insider wrote that only a couple of years ago, scientists were still arguing over whether aging was a disease; Insilico’s summary said the FDA’s stance was that progress does not depend on defining aging as a disease, but on validated, function-based measures and shared data34.
What to watch next
- Publication of the updated science-priorities report and exactly how it describes aging and longevity1.
- Whether companies form the shared biomarker group Penzenstadler called “the number one thing that is actionable”2.
- Whether any company submits a trial plan to the FDA with aging, rather than a single disease, as its target2.
- Results from ARPA-H’s PROSPR teams on measures of healthy aging5.
