Judicial Watch • Criminals Conduct FDA Research

Criminals Conduct FDA Research

Criminals Conduct FDA Research

OCTOBER 22, 2009

Government scientists convicted of fraud conduct essential drug and biologics research because the notoriously derelict federal agency responsible for protecting public health and safety doesn’t bother removing them.

To avoid compromising the safety of crucial clinical trials that determine the approval of drugs and medical devices, federal law bans any research to be administered by individuals who have been convicted of fraud. Because they risk altering the integrity of important data, it’s the responsibility of the Food and Drug Administration (FDA) to banish them from all taxpayer-funded trials.

Instead, the FDA regularly fails to debar individuals who have been convicted of felonies related to the development, approval or regulation of a drug or biologic. The agency takes anywhere from a year to more than a decade to ban criminals from conducting drug trials, according to a lengthy congressional report published this week.

Congressional investigators considered dozens of cases and found that the FDA took an unacceptable amount of time to disqualify researchers who had previously falsified data. In most instances, the scientists continued working on other important trials that determined whether an investigational product is safe for the U.S. market. 

In one case, the FDA took years to ban a study coordinator involved in one of the nation’s largest cases of drug-trial fraud. The woman operated a southern California institute that conducted nearly 200 studies for practically every big pharmaceutical in the world and routinely falsified data. She eventually pleaded guilty to fraud but the FDA didn’t take action for half a decade. 

This sort of negligence is nothing new at the FDA, which perpetually fails to enforce federal laws that could negatively impact the profits of the wealthy pharmaceuticals that pay the agency hundreds of millions of dollars in “fees.” In fact, a separate congressional investigation determined that the FDA allows firms that annually pay it more than $400 million in fees to compromise public safety.

Earlier this month a group of scientists chastised the agency for delaying a negative report on a common household chemical deemed unsafe in hundreds of studies and banned in several states. To appease the chemical’s manufacturer, the scientists say, the FDA has disregarded the reputable research and will spend $7 million to further study the chemical which is used to make clear plastic.

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