Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete confirmatory clinical trials past their original planned completion dates, a new report by the Office of the Inspector General has found.
According to the report:
“The accelerated approval pathway allows FDA to approve certain drugs that treat serious or life-threatening diseases and offer meaningful therapeutic benefit to patients over existing treatments before confirmatory trials are completed.”
“As a requirement of granting accelerated approval, FDA requires sponsors to commit to complete confirmatory trials with due diligence, meaning the trials must be conducted promptly.”
“Of the 37 confirmatory trials past their original planned completion dates, 14 are delayed more than 1 year… past their original completion dates”
“[F]or a variety of reasons, sponsors do not always complete trials promptly… These challenges can result in drugs staying on the market—and being administered to patients—for years without the predicted clinical benefit being verified.”
The full report is available online or can be downloaded below.