FDA Lax on Clinical Trials, HHS IG says

In a familiar tale of underfunded mandates and lax oversight, a report due out today will say the FDA falls short in monitoring the safety of patients in clinical trials, the New York Times reports.

The agency has 200 inspectors responsible for monitoring 350,000 testing sites. Obviously, given that load, they don’t manage to audit all that many of them. But even when the inspectors found serious problems, their higher-ups in Washington downgraded their findings 68% of the time, according to the report by the inspector general of the Department of Health and Human Services.

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” Arthur Caplan, medical ethics guru at the University of Pennsylvania, told the paper.

The FDA isn’t the only body tasked with monitoring clinical trials. Every study also must be approved and reviewed by a committee of experts called an institutional review board, or IRB.

But the FDA is also supposed to oversee the safety of trials run companies who want the agency to approve their drugs or devices. The agency found serious problems at trial sites 348 times between 2000 and 2005, but disqualified trial data only twice during the period, the NYT says.

The report recommends that the agency create a registry of all continuing clinical trials. (The new drug safety law will require such a registry.) The report also recommended the creation of a database to track the agency’s research inspections and greater authority to regulate research assistants.