FDA Knew Lab Committed Research Fraud, Approved Drug They Tested Anyway

After the U.S. Food and Drug Administration learned about potentially fraudulent work done on behalf of pharmaceutical companies by a contract research firm in Texas, they didn’t pull the drugs off the market. You might think, though, that they might hold off on approving new drugs based on testing that came from that lab. You would be wrong.

Before they hit the market, generic drugs must undergo testing to show that they’re bioequivalent, which is a fancy way of saying “they do the same thing as the name brand.” Last week, we shared ProPublica’s reporting on a lab that cut corners in some of the tests it was hired to perform. The drugs went on to be approved and hit pharmacies and store shelves all over the world. The FDA won’t tell the public which drugs those were, and as far as we know they remain on the market in the United States. Now there’s something worse: drugs approved based on testing that the FDA already knew could be fraudulent.

The medication in question is another generic: Tussionex, a narcotic cough suppressant and antihistimine. The FDA didn’t just shrug and wave the drug through. A consultant audited the troubled lab’s data, and the FDA okayed the audit, saying there was no evidence that the drug is unsafe. As far as the research from the troubled lab shows.

FDA Approved New Drug Despite Ongoing Investigation of Lab Misconduct [ProPublica]