More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years past their confirmatory trial deadlines, according to a recent report released by the US Department of Health and Human Services Office of Inspector General (OIG).
“The accelerated approval pathway holds promise for patients who face serious illnesses where adequate treatments are lacking. In the best-case scenarios, sponsors complete confirmatory trials promptly and provide evidence to verify the drugs’ clinical benefits. In those cases, FDA enables patients to access drugs that can help them and Medicare and Medicaid to pay for effective treatments,” the authors of the OIG report wrote…
