PharmExec Blog

Feds Publically Spank Bad Investigators

A pair of standard law enforcement handcuffs
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FDA, late on Friday, announced that it would ramp up efforts to keep naughty investigators from working for companies with approved or pending drug applications.

“The FDA views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,” stated Norris Alderson, the FDA’s associate commissioner for science. “We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”

According to an FDA release, it can ban or debar any investigator that has broken the law or falsified data. The administration doesn’t flesh out what exactly is being “enhanced,” but states that it will boost the number of staff and “centralize coordination” in an attempt to speed up the debarment process.

To make life easier for sponsors, the feds have created a Web site listing all disqualification proceedings and are working on a similar site for debarred investigators.

The site basically outs, by name, any investigator that purposefully submits false information to the pharma company or FDA. Names are defined as either restricted (they can work, but under close supervision) or totally restricted (can’t receive any investigational product) depending on the outcomes of the hearing process.

There are currently just shy 150 names outed on the disqualified list. According to FDA, publically naming individuals is justified under the Freedom of Information Act, and is another example of how the agency is trying to be more transparent.

“From 2006 to present, FDA initiated 21 disqualification actions,” according to FDA’s Web site. “Of these, 18 actions have been completed, and three are currently pending further action.”

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