Delayed Post-Market Studies Leave Patients in the Dark

The FDA's reliance on post-market studies to assess the safety and effectiveness of approved drugs has come under scrutiny. Hundreds of provisionally approved drugs and devices have not conducted required post-market tests, leaving providers and patients in a state of uncertainty.

When Tavneos was approved for treating rare autoimmune diseases, FDA experts expressed concerns about the limited safety data provided by the manufacturer, Amgen. The drug was granted approval with a proviso: additional years-long safety studies would be conducted once it was on the market.

However, as of last fall, only 21 of the planned 300 patients had been enrolled in the study, according to an FDA letter and regulatory posting. Dozens of cases of liver damage have been linked to the drug, a potential side effect the post-market study aimed to evaluate.

The FDA has identified hundreds of delayed post-market studies, with some delayed by over a decade or still without a plan. As a result, patients, doctors, and others may be left in the dark about the risks and benefits of these products.