The FDA’s incompetence is outed in a report by the Department of Health and Human Service released today. The DHHS confirms the Institute of Medicine’s earlier criticism of the FDA.
It is apparent from the report that the FDA is overwhelmed and cannot deal with the volume of clinical trials. The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites.
Relying on the pharmaceutical companies to police their own clinical trials is like allowing the proverbial fox to guard the hen house.