Researchers Banned (and Some Jailed) by the FDA

For researchers, negative feedback from the ethics board is bad news. Negative feedback from the Food & Drug Administration is very bad news, for individuals and for the companies that might want to employ them. In serious cases, the FDA can debar individuals or organizations from participating in, for example, submitting a new drug for approval. That could put a serious damper on a researcher’s career, and on a company’s financial outlook. And in some cases, at least, jail time is a distinct possibility.

Here’s a news item about a bunch of such individuals, from The Scientist: Biotech’s Baddies

No matter how bad things seem for the United States Food and Drug Administration these days, 20 years ago they were arguably worse. In the late 1980s, the agency was embroiled in a generic-drug scandal, in which FDA administrators accepted bribes for quick drug approvals, and drug makers admitted to deliberately defrauding drug regulators. The days when the federal agency could rely solely on the trustworthiness of the industry it was supposed to be regulating were done.

But from the ashes of the generic-drug scandal, some positives did arise. One of the programs resulting from the scandal, and the subsequent Generic Drug Enforcement Act of 1992, was the FDA’s mission to “debar” people or whole companies from participation in agency activities, such as applying for drug approval, if found guilty of deliberate fraud.

David Read, who was the FDA’s first Debarment Task Force chair, says that when the agency first set out to ban investigators for fraudulent activities involved with the generic-drug scandal, the magnitude of dishonesty in the drug business was staggering. “[The Generic Drug Enforcement Act] resulted in a lot of investigations, which turned up a lot of surprises,” he says. “As people started investigations, they found things that weren’t expected….”

~ by Nancy Walton on April 3, 2009.

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