FDA Allowed New Drug on Market Despite Fraudulent Lab Tests

FDAfinal

Although the Food and Drug Administration was aware that a major pharmaceutical research laboratory in Houston had falsified data and was engaged in “egregious” violations which undermined the safety and effectiveness of dozens of medications, the watchdog, responsible for protecting and promoting public health, approved those very drugs and allowed them to remain on the market.

According to Propublica:

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.

ProPublica discovered that both of the clinical trials used to show that the generic is equivalent to the name brand — a key requirement for FDA approval — were analyzed in May and June 2009 at the Houston lab of the firm Cetero Research. The company, which conducted research for scores of pharmaceutical companies, has acknowledged that chemists at its Houston lab committed research fraud, though it says the misconduct was limited to a handful of employees and that none of their tests have so far proven to be wrong or inaccurate.

Read More Here.

 

 

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