The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.

When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of rare autoimmune diseases, agency experts argued that would be a mistake, according to FDA records. One problem cited: The manufacturer had provided only “limited safety data.” As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the drug was on the market. Today, like many similar “postmarket” studies mandated by the FDA, that additional study is delayed, according to a federal database. As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an April letter and regulatory posting. Meanwhile, the FDA has identified dozens of cases of liver damage “possibly” or “probably causally associated” with the drug. That was one of the potential side effects the postmarket study was meant to evaluate. Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through. A KFF Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the w...