FDA's Postmarket Study System Fails Patients with Flawed Evidence

The US FDA has come under scrutiny for its approach to postmarket studies, which are meant to evaluate the long-term safety and efficacy of approved drugs and medical devices. According to a KFF Health News analysis, hundreds of these studies have been delayed, with some cases stretching back over a decade.

One such example is Tavneos, a drug used to treat rare autoimmune diseases. The FDA approved the drug in 2021 but required the manufacturer to conduct an additional safety study once it was on the market. However, as of last fall, only 21 of the planned 300 patients had been enrolled.

Despite these delays, the FDA has identified dozens of cases of liver damage 'possibly' or 'probably causally associated' with Tavneos. The manufacturer, Amgen, is still working on the postmarket research but remains committed to completing it.