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Posted By
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March 17, 2008, 9:36 am
Flag as Inappropriate gbyrd
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Subject
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Generic standards might be off
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Many are coming forward claiming that the FDA's standards for approving generic medication might be off. By the FDA's defenition a generic drug must be the complete bioequivilant of its surrogate, and deliver virtually the same amount at virtually the same rate as the pioneer drug.
According to the Las Angeles Times there could be several flaws in the FDA's standards of comparison.
First, the agency's tolerance for variance in the content and release of a drug's active ingredient -- the healing compound -- may be too broad.
Second, the FDA does not demand realistic trials of different formulations in large patient populations.
And third, by measuring a generic medication's ability to deliver a drug compound to the bloodstream, the FDA may be looking in the wrong place. Most drugs work their magic not in the blood but in organs, cells or tissue elsewhere.
In fact, a brand-name drug's generic counterpart is rarely an exact replica. Though the two share equal amounts of the same active ingredient, they generally look different. And those differences, say some pharmacologists, can result in small variations in how they work in patients.
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Comments
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March 17, 2008, 2:06 pm
Flag as Inappropriate jazzycatzz says...
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Realistic trials are mandatory. Either take this step or don't approve the drug. Don't worry; enough will complain about the lack of a generic to make the lack of one short-lived. The FDA is nothing if not acquiescent.
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March 26, 2008, 7:53 pm
Flag as Inappropriate Cassie says...
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I never worried about generic medicine and usually ask if my med is available in generic. What you say makes sense, but would you mind If I ask where you learned about this?
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March 28, 2008, 12:34 pm
Flag as Inappropriate sacback says...
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It's funny how if you aren't paying over a certain amount of money for your medication, you have no other choice but to get generic. And personally I sometimes wonder if the crap is even working.
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