Supporting detail
The current process has too much dead time
The transcript says 45% of the time between Phase 1 and the final FDA application is dead time, with no ongoing clinical trial.
Dead time has grown, not shrunk
The transcript says dead time was about 25%, then 35%, and now 45%, even while time spent in actual clinical trials is decreasing.
Connected idea: the system has become more paperwork-heavy over time.
Paperwork was called out directly
Makary said investigators and staff are doing tedious paperwork and other tasks during this dead time instead of advancing an active trial.
Connected idea: administrative drag is a stated target for reform.
The 66 million page example
The transcript uses one application of 66 million pages to show how far the process has drifted into excess documentation.
Connected idea: FDA wants a more workable information flow.
The stated goal
Makary said FDA must ask what parts of the workflow can be made more efficient without cutting any corners on safety.
Connected idea: speed is being framed as process reform, not lower standards.