Myth of Generic Drugs

Because most health plans encourage the use of Generic drugs over higher cost name brand drugs and most states allow pharmacies to substitute generic drugs for brand name drugs if the generic is considered equivalent, many patient are routinely switched from the brand name drugs to the generic.

Indeed, it is commonly assumed by most consumers that brand name drugs and generic drugs are equivalent. But most consumers are in for a big surprise.

In contrast to the Food and Drug administration (FDA) regulations for new drug applications, which require clinical trials and a description and analysis of any other data or information on the safety or effectiveness of the drug, the FDA process required for generic equivalents, only require that the generic is the bio-equivalent to the brand name drug.

However, generic drugs are pharmaceutical equivalents only with respect to their active ingredients, and current regulations allow for up to 20% variation in the bio- availability of the drug once ingested. The binders, diluents and fillers in the formulation of the drug, as well as the method of manufacture, vary from name brand to generic to generic.

Numerous medical studies have reported the dire consequences of switching patients from name brand drugs to generics. For example. in 2007,  the American Epilepsy Society issued a warning opposing the substitution of anti-epileptic drugs without patient and physician approval. This occurred after receiving reports that patients with well controlled seizures suffered break through seizures after being switched to a generic drug substitute. The results could be devastating including lost jobs, license revocation, and serious accidents.

Unfortunately the manufacturers of many generic drugs are not warning the public that generics are not identical to the name brands. So the catch word is buyer beware and be sure to discuss with your physician the equivalency of any generic drug that may be given for the brand name that you are prescribed.