Quote:
Originally Posted by Z K
"All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name." Quoted from the FDA web site. I've seen a lot of generic products never make it to market and approvals get yanked.
Of course generics are needed. The costs are much less than the branded drugs. Customers save money in getting the same products. And in the case of "authorized generics", they are even made by the same companies who make the branded product and is essentially the same product!
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"Essential similarity" or bioequivalence is the only requirement the FDA has of generic manufacturers.
From the same page you quote: "Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug."
So they are the same?
Here's what a 2 second search on NCBI provided (click the link to read the abstract):
Few publications compared the bioequivalence and efficacy of brand-name and generic psychoactive drugs. Those that were identified revealed differences in the efficacy and tolerability of brand-name and generic psychoactive drugs that had not been noted in the original bioequivalence studies.
There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4
To conclude... the patient had a fainting spell in his apartment, after which his blood pressure was found to be 220/120 mm Hg. Medication compliance did not appear to be an issue, but the same “family” physician realized that the patient had been switched to a generic ($30.25/mo v. $36.56/mo for the brand medication). The original brand was immediately restored, and 2 days later blood pressure was back down to 150/90 mm Hg. My father subsequently died from a dissected aorta, a well-known complication of high blood pressure.