FDA approved new drug despite ongoing probe of lab misconduct

FDA Approved New Drug Despite Ongoing Investigation of Lab Misconduct
by Charles Seife and Rob Garver, Special to ProPublica, April 22, 2013, 9:22 a.m.

Last week, ProPublica reported that the Food and Drug Administration allowed dozens of medications to stay on the market, even though the research designed to prove their safety and effectiveness was undermined by “egregious” violations at a major pharmaceutical research laboratory in Houston. New information shows that even after the FDA had cited the lab for falsifying data and other misconduct, the agency issued a brand new approval to a drug tested there.

The FDA has refused to reveal the names of any of the approximately 100 drugs affected by the fraud at the Houston lab of the firm Cetero Research, saying that to do so would reveal confidential commercial information. ProPublica was able to identify five of those drugs, and now we’ve found a sixth. This one was approved after the agency had already cited the Houston lab for misconduct.

The drug is a generic version of Tussionex, which combines a long-acting narcotic cough suppressant with an anti-allergy medication. Manufactured by TrisPharma, the drug has a tongue-twisting chemical name: hydrocodone polistirex/chlorpheniraminepolistirex.

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