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Podcast: What Should the FDA Do When Drug Tests Are Tainted?

(The U.S. Food and Drug Administration/Flickr)

In an investigation published yesterday, Rob Garver and Charles Seife shared the story of how the Food and Drug Administration found a lab in Houston, Texas, that had provided the agency with drug tests tainted by "egregious" research misconduct. While the FDA's counterpart in Europe took seven of the improperly tested drugs off the market, the FDA did not follow suit.

Garver and Seife joined the podcast to discuss how the FDA typically handles situations like this, how the agency found out the tests were not conducted improperly, why the European Medicines Agency pulled the drugs, which drugs were involved, and why the FDA has not been forthcoming with more information.

"We certainly believe that the FDA ought to be more transparent, but it's not just us," said Garver. "Dr. David Kessler, the former head of the FDA, is on the record in the story concerned that the FDA hasn't been sufficiently transparent about this. He says that you can't just ask the public to trust you."

Seife added, "I think they (consumers) have to be worried about the process rather than any individual drug. The FDA is the watchdog — it is the agency that is supposed to keep us safe. And when it says that it can't tell us why these drugs are put on the market, despite the fact that we know that their experimental basis for the safety and efficacy of these drugs is undermined, [that] makes us question whether the FDA is hiding something."

Mike Webb

Mike Webb was the vice president/communications of ProPublica. He is a veteran communications specialist with experience in public relations, marketing, sales and campaign work at media companies, think tanks, political organizations and in the entertainment business.

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