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HealthActive today · day 6

KFF analysis: Hundreds of FDA-ordered postmarket drug studies delayed or incomplete

A KFF Health News investigation found hundreds of follow-up studies mandated after drug approval are running behind schedule, raising safety concerns as the Trump administration pushes faster approval.

newest coverage 19h agosummary written 19h ago6 pieces1 likes & upvotes NewswiresMastodon

What to know

  • KFF analysis found hundreds of FDA-mandated postmarket studies delayed or incomplete, with some overdue by more than a decade, leaving patients and doctors uncertain about drug safety.
  • Tavneos, approved in 2021 despite internal FDA concerns, exemplifies the problem: its postmarket safety study has enrolled only 21 of 300 planned patients while dozens of liver damage cases linked to the drug have emerged.
  • Trump administration policy reducing required pre-approval clinical trials from two to one will shift more regulatory burden to the already-struggling postmarket system, researchers warn.
most voices

FDA's speed-focused approval strategy with weak postmarket enforcement exposes patients to inadequately studied drugs.

  • “Tavneos illustrates the perils of the FDA's approach to many drugs and medical devices — and the frequent lapses in follow-through. A KFF Health News analysis...found hundreds of postmarket studies listed as delayed.”

    bich@apobangpo.space · Mastodon ↗

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it's going to lead to a lot of uncertainty.”

Sanket Dhruva, Cardiologist and associate professor of medicine, UC San Francisco · KFF Health News ↗ · Sep 17

Sanket Dhruva Cardiologist and medicine professor, UC San FranciscoAaron Kesselheim Medicine professor, Harvard Medical SchoolFDA Regulator approving drugs and setting postmarket study requirementsDepartment of Health and Human Services Federal agency overseeing FDA

KFF analysis: Hundreds of FDA-ordered postmarket drug studies delayed or incomplete
kffhealthnews.org

How it unfolded 1 development · click the chart to see its coverage articlesposts

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Sep 19Sep 20Sep 21Sep 22yesterdaynow · 3:50 AM ET
  1. 1

    Researchers warn faster pre-approval testing will increase reliance on weak postmarket oversight

    Medical researchers warn that Trump administration policies reducing pre-approval testing will put more pressure on the postmarket system, which is already plagued by delays and enforcement failures. The shift risks exposing patients to drugs that may cause more harm than benefit.

    “Reducing pre-approval testing "will inevitably put a lot of pressure on the post-approval system,"”
    — Aaron Kesselheim, professor of medicine, Harvard Medical School
    • bich@apobangpo.space

      "Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through. A KFF Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still…

      bich@apobangpo.spaceMastodon3d ago1▲view on Mastodon ↗
  2. background

    KFF Health News analysis finds hundreds of postmarket studies delayed or incomplete — A comprehensive analysis of FDA data by KFF Health News reveals hundreds of postmarket studies are behind schedule. Some have been delayed more than a decade, and manufacturers in some cases are still developing study plans, leaving patients and doctors uncertain about drug risks.

  3. background

    FDA reveals Tavneos postmarket study significantly behind enrollment targets — FDA documents show only 21 of 300 planned patients enrolled in the Tavneos safety study as of the previous fall. Meanwhile, dozens of liver damage cases have been identified possibly or probably linked to the drug.

  4. background

    Trump FDA announces single clinical trial will become default for approvals — FDA leaders announced that the default requirement for agency approvals will shift from two clinical trials to one, citing cost reduction and faster market access for manufacturers.

  5. background

    FDA approves Tavneos with postmarket study requirement — The FDA approved the drug Tavneos to treat rare autoimmune diseases despite internal expert concerns, conditional on the manufacturer conducting a long-term postmarket safety study.

Also covered reported alongside — the timeline has no entry for these yet

  1. 5 outlets The FDA requires follow-up studies for drugs and devices. Years later, many still aren’t done

    first by GovExec, 5d ago · also Orlando Sentinel, Mercury News, Baltimore Sun, KFF Health News

    1 more headline

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