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Antidepressant recall and FDA admission: no testing on generics

People in Troy may have heard that earlier this month the federal Food and Drug Administration issued a recall of the 300 mg generic version of Wellbutrin XL. Though this may have seemed like every other recall, the FDA also made a startling revelation: the FDA has not been testing generic drugs at all dosages before allowing them to be marketed to the public. Instead, the federal watchdog for drug safety assumed that because the 150 mg dose worked, that the 300 mg dose would work, as well.

The recall and the FDA's admission came nearly five years after reports started pouring in about how ineffective the 300 mg dose was. Individual consumers also noticed side effects from the drug and, eventually, a journalist team compiled the hundreds of complaints and contacted the FDA. Did the FDA start an investigation at that point? No, it just wrote off patient complaints as sensitivity to a change in medication.

Now that the FDA has come clean about it unscientific methods of approving generic medications, many in New York might believe that the organization would start pulling all the drugs that it had approved in that manner. People that thought that would be wrong, however. Instead of recalling drugs and testing them for safety and efficacy, the federal agency has called on the manufacturers to test their own drugs and report back by March 2013. But what is to prevent manufacturers from just claiming that their medications are safe without doing any real testing? Nothing, it seems.

No one in Troy should be injured because of faulty drugs. Whether the FDA fails to properly check medicines or not, it is a drug manufacturer's responsibility to always ensure that it is producing medicine that is safe and effective. If it doesn't, it may open itself up to a product liability lawsuit.

Source: Forbes, "A Drug Recall That Should Frighten Us All About The FDA," David Maris, Oct. 10, 2012

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