The U.S. Food and Drug Administration often approves drugs and devices with the condition that companies complete additional studies after the products are on the market. But a new report shows that many of these FDA-ordered studies still have not been done, even years later, leaving safety and effectiveness questions unresolved.
One example highlighted in the report is the drug Tavneos, approved to treat a set of rare autoimmune diseases. According to FDA records, when the agency was deciding whether to approve the drug, some agency experts argued that doing so would be a mistake. The report does not specify exactly what those experts feared, but it places the decision within a broader pattern of postmarketing requirements going unfulfilled.
The findings point to a gap between the FDA's approval conditions and its follow-through. While the agency can order studies, it appears to have limited leverage or capacity to ensure they are completed in a timely manner, leaving both regulators and patients without the data that were promised.