The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.
To get drugs and devices out faster, the FDA lets companies conduct studies of safety or efficacy after the products are approved. In many cases, such “postmarket” studies are behind schedule or overdue, records show.
In 2021, the FDA approved the drug Tavneos for treating rare autoimmune diseases, but with a condition. The manufacturer was ordered to conduct an additional safety study once the drug was on the market. As of the latest update in April, only 21 of the 300 planned participants had been enrolled in this study. The FDA has identified numerous cases where patients experienced liver damage that could be linked to Tavneos, one of the conditions the study was supposed to evaluate.
This story highlights the issues with the FDA's approach to postmarket studies on drugs and medical devices, as well as the frequent delays in completing these studies. An analysis of FDA data by KFF Health News revealed many such delayed studies, some of which have been held up for over a decade. This delay can leave patients, doctors, and others uncertain about the safety and benefits of these products.
Postmarket study requirements, while intended to balance the speed of bringing new treatments to market with ensuring their safety and efficacy, have proven to be largely ineffective. The pressure to expedite drug approval, as seen with recent changes under the Trump administration, could exacerbate these issues.
Written by urgent.news from KFF Health News's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
