The drugs and devices have been on the market for years, but FDA-ordered studies still aren't done
When the U.S. Food and Drug Administration (FDA) was deciding whether to approve the drug Tavneos several years ago to treat a set of rare autoimmune diseases, but agency experts argued that would be a mistake, according to FDA records.
The U.S. Food and Drug Administration (FDA) approved Tavneos, a drug for rare autoimmune diseases, in 2021 with a condition: the manufacturer must conduct a long-term safety study once it is on the market. As of last fall, only 21 of the planned 300 patients had enrolled in this post-market study. The FDA has identified numerous cases of liver damage potentially related to Tavneos, one of the conditions the study was meant to evaluate.
This highlights the issues with the FDA's approach to post-market studies for many drugs and medical devices, as hundreds of these studies are now delayed, sometimes by more than a decade. Dr. Sanket Dhruva, a cardiologist and professor, notes that post-market studies have often been ineffective in resolving questions about the risks and benefits of these products, potentially exposing patients to harmful treatments.
The recent policy change by the Trump administration to reduce preapproval testing could further strain the post-market system, putting more pressure on these delayed studies. Despite the FDA's stance that delays are not always evidence of unresolved issues, the reliance on these studies to inform patient, doctor, and healthcare system decisions remains uncertain.
Drug manufacturer Amgen is still working on the required study for Tavneos, committing to its completion.
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