Pharmer.org

It amazes me that there are so many postings about what generics can and can not have. I do admit that I have found that certain ones work better than others for me, not sure why. I was on the FDA site the other day and found this so I thought I would throw it out there.

Direct copy from the FDA site

"Generic Drug

A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product."

 It is true that a generic product must contain the same amount of active ingredient but it having the same amount of active ingredient doesnt necessarily mean that it is bioequivalent. I will try to explain how I understand it after the quote from the FDA, so here is what the FDA uses to calculate bioequivalence.

 "FDA considers a test product (generic) to be bioequivalent to a reference product (name brand) if the 90% confidence interval of the geometric mean ratio of AUC and Cmax (blood concentration of active ingredient) between the test and reference fall within 80-120%"

 Basically the bioequivalency test needs to prove with a 90% certainty that the Cmax, AUC & Tmax levels do not vary more than +/- 20% from the reference product. The +/-20% blood concentration (Cmax) or time it takes to achieve said concentration (Tmax) whether it be on the low end or high end is usually so minute that the end user wont notice any difference.

 All this aside there are going to be that small percentage of factories/companies that are greedy, just flat out lazy or where honest mistakes happen and will still have no problem passing on an inferior product and in some instances giving the FDA falsified test samples to cover there butt. There are plenty of records for a lot of really big pharma companies such as Mallinckrodt,Acatvis and Qualitest/Vintage etc. where they were putting out either sub-potent or super-potent products. Usually ending up in recall but I highly doubt they catch all the mistakes that happen.