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

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The Drugs and Devices Have Been on the Market for Years

Overview

The FDA has mandated postmarket studies for drugs like Tavneos. As of last fall, only 21 of 300 planned patients had been enrolled in Tavneos' postmarket study, despite identified cases of liver damage potentially linked to the drug.

Background

Postmarket studies are crucial for assessing the long-term safety and efficacy of drugs and devices after they have been approved. Delays in these studies can leave healthcare providers and patients uncertain about the risks and benefits of treatments.

Data Highlights

As of last fall, only 21 of the planned 300 patients had been enrolled in the Tavneos postmarket study.

Key Findings

  • The FDA approved Tavneos with a requirement for a postmarket safety study due to limited initial safety data.
  • As of April, the FDA reported that only 21 patients were enrolled in the Tavneos study, with many studies delayed.
  • Dozens of cases of liver damage have been identified as possibly linked to Tavneos.
  • Nearly 600 postmarket studies are currently delayed, affecting over 350 products.
  • Changes in FDA policy may increase reliance on postmarket studies, potentially impacting patient safety.

Clinical Implications

Healthcare providers should be aware of the limitations of available safety data for drugs like Tavneos.

Conclusion

Delays in postmarket studies highlight the need for ongoing scrutiny and regulatory oversight.

Related Resources & Content

  1. KFF Health News, 2023 -- The Drugs and Devices Have Been on the Market for Years
  2. MDSpire News — Breakthrough Device Approvals Outpacing Data
  3. Associated Press Health — FDA drug approvals: Makary and Prasad say one study will be enough
  4. the asco post — Fewer Than Half of Drugs Granted Accelerated Approval Demonstrated Benefit Within 5 Years
  5. MDSpire News — Study Shows Widespread Delays in Medical Device Reporting to FDA
  6. FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos
  7. Postmarketing Requirements and Commitments: Introduction | FDA
  8. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update
  9. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis - PubMed
  10. CDER proposes to withdraw approval of TAVNEOS | FDA
  11. Letter NOOH Taveneos (avacopan)
  12. RETRACTED: Avacopan for the Treatment of ANCA-Associated Vasculitis | New England Journal of Medicine
  13. Trial paper is retracted as FDA keeps scrutiny on controversial vasculitis drug

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

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