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Friday 28th October 2016

FDA 'fails' to police clinical trials

2nd October 2007

The US drug regulator does very little to ensure the safety of people who volunteer for clinical trials to test new drugs, a new report says.


Daniel Levinson, inspector general of the Department of Health and Human Services, says officials at the Food and Drug Administration have little idea of how many clinical trials are under way at any given time, and carry out audits on less than 1% of them.

Instead, they may show up to audit trial sites long after studies are concluded.

Levinson's department is in charge of the FDA, which is best known for approving drugs new to the US market. The FDA relies heavily on the results of clinical trials on human subjects to make decisions related to approvals.

Accused of sloppiness in overseeing trials, FDA officials say they lack resources to do their job properly, adding that it only has 200 inspectors to cover 350,000 testing sites.

According to the report, negative reports from FDA inspectors in the field were altered by their bosses in Washington to appear more favourable in 68% of cases.

Between 2000 and 2005, the agency found serious problems at trial sites on 348 separate occasions. However, they have only disqualified researchers 26 times, and disqualified the data they produce only twice during that time.

Levinson said the FDA should set up a registry of all ongoing clinical trials. The agency has just been voted more powers and money to boost its regulatory capacities, in an attempt to reduce the incidence of dangerous side effects from prescription drugs being reported only after they reach the market.

The legislation is largely a response to a string of drug safety controversies, including the 2004 withdrawal of Merck & Co Inc's widely used arthritis pill Vioxx after it was linked to heart attacks and strokes.

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