Tuesday, April 1, 2014

FDA Now Testing Generic Drugs At Leading Academic Centers

The Food and Drug Administration has announced that it will launch a new generic drug testing program that will affect all generic products in the United States. The testing program will take place at leading academic centers across the country, and will sample various generic drugs.
In most cases, pharmaceutical companies perform their own testing on their products, creating what some medical experts call “the honor system.” These same experts believe that having pharmaceutical companies test their own drugs has led to lower quality products, which has negatively affected patients and the medical community.
The issue first hit the mainstream media when the FDA became aware that Ranbaxy, the largest drug producer in India, was altering drug testing to make products appear to be better than they actually were. The revelation called the FDA's own practices into question, since it had inspected a Ranbaxy plant in 2004 and found no problems. Eventually, the FDA found that Ranbaxy was not up to standard on quality control or record keeping. The company was fined $500 million, and Ranbaxy drug products are not currently allowed into the United States market.
The FDA has also become aware of domestic drug producers that have falsified data. In 2009, the FDA became aware of falsified data from Cetero Research, a lab based out of Houston. The lab had passed FDA inspections numerous times, but the FDA eventually found that drug tests during the period of 2005 and 2010 were not reliable. The company has since shut down.

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