The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done. - Summary - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done.

“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."

  • By

  • David Hilzenrath

  • September 22, 2026

  • 14 min

Share

Objective:

To highlight the delays in postmarket studies mandated by the FDA for drugs and medical devices and the implications of these delays on patient safety and information.

Approach:
  • FDA Approval Process: The article discusses the FDA's approval of Tavneos with a requirement for postmarket studies due to limited safety data.
  • Analysis of Delays: A KFF Health News analysis reveals hundreds of postmarket studies are delayed, affecting patient awareness of risks and benefits.
  • Expert Opinions: Experts express concerns about the reliability of postmarket studies and the impact of recent FDA policy changes on safety.
Key Findings:
  • Only 21 of 300 patients were enrolled in the Tavneos postmarket study as of last fall.
  • The FDA has identified numerous cases of liver damage associated with Tavneos.
  • Almost 600 postmarket studies are behind schedule, with over 250 due before July 31, 2026.
  • Delays in postmarket studies can lead to uncertainty for patients and healthcare providers regarding the risks and benefits of drugs and devices.
Interpretation:

The FDA's reliance on postmarket studies to evaluate drug safety and efficacy may expose patients to risks without adequate evidence.

Limitations:
  • Delays in studies may not indicate unresolved safety or effectiveness issues, as stated by the Department of Health and Human Services.
  • Some studies face challenges due to the rarity of conditions or other logistical issues, which may affect timely completion.
Conclusion:

The ongoing delays in postmarket studies raise concerns about the adequacy of safety evaluations for drugs and devices already on the market, as highlighted by experts. Compliance with FDA requirements is crucial for ensuring patient safety and informed decision-making in healthcare.

Original Source(s)

The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done.

  • by David Hilzenrath

  • September 22, 2026

Related Content

Cumulative training load may signal musculoskeletal injury

Wearable sensor measures showed associations with musculoskeletal injury, but evidence certainty remained very low.

FDA, CMS target gene therapy barriers

FDA and CMS initiatives aim to simplify gene therapy approvals and expand access to treatments for rare diseases.

FDA updates PAH label with trial data

In adults diagnosed with pulmonary arterial hypertension within the previous year, adding sotatercept to background therapy reduced the risk of clinical worsening events by 76% compared with placebo.