FDA's Broken Promise: Safety Studies Lag

Hundreds of postmarket studies mandated by the U.S. Food and Drug Administration are facing significant delays, with some waiting for over a decade to be completed. These crucial safety and efficacy studies, intended to evaluate drugs and medical devices after their approval, are falling behind schedule, leaving patients and doctors uncertain about product risks and benefits.

KFF Health News analysis revealed nearly 600 delayed studies for drugs and biologics, impacting close to 350 products. In some cases, manufacturers are still developing study plans years past their deadlines. This lack of follow-through raises concerns about patient exposure to potentially harmful products and the effective use of healthcare funds, as billions are spent on accelerated approval drugs with incomplete trials.