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The FDA Is In Over Its Head with Generic Drug Labeling

Some medicines do not produce the effect they were approved for

By Tudor Vieru, Science Editor

7th of October 2008, 07:24 GMT

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Generic drugs are not as effective as their brand-named counterparts.
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The American Food and Drug Administration is currently backed into a corner, as reports about generic drugs being inefficient keep coming in, despite the fact that the FDA approved and cleared them as being equivalent to the brand-name products they are to substitute at a lower price. Independent analysts discovered that, in some cases, there were severe discrepancies between the insert of some products and the official releases on FDA's website.
 

An analysis by ConsumerLab.com, a major provider of reliable third-party information about products relating to health and nutrition, has revealed that generic pills, while having the same active ingredients as their brand-named counterparts, vary significantly in distribution times inside the body. In other words, it can take up to 10-20 percent longer for generic drugs to kick in after they have been taken. FDA considers these margins to be safe, but consumers using these medications have reported that symptoms that were inhibited with the use of regular drugs have re-appeared and that their conditions deteriorated.


After switching back to their original prescriptions, patients reported a decrease in symptoms they were treating. This is very strange, because the FDA supposedly makes sure that all generic drugs have the same active ingredient, dosage and composition as their more expensive, already branded counterparts, before releasing them. The question is, how is it possible for the generic drugs not to be as effective? According to ConsumerLab.com, the answer lies with the "permissive" regulations the FDA employs when it comes to testing new generic drug release proposals.


People looking into the matter have discovered that many portions of various drugs' descriptions on the FDA website have been deleted from the archives, which means that the package inserts do not have to be 100 percent accurate. In regard to all the complaints it receives, the FDA, in an unprecedented move, plans to retest some of the generic pills it approved, hoping to advert further criticism.

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FDA | ConsumerLab.com | generic drugs
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