Generic Drugs Vs. Brand Name Drugs

Generic drugs have the propensity to be as effective and useful as brand name drugs (not to mention as much as 90% cheaper), but when prescribed or filling a prescription and receiving the generic I always err on the side of caution. Generally speaking, I have had much success with generic antibiotics and other medications, but I am well aware that there remains the possibility that new or different side effects may results from the generic version.

ABC News recently did a segment on the difference between generic and brand name drugs in which a representative of the Food and Drug Administration (FDA) admitted that some drugs, including the thyroid drug Synthroid, have a "narrow therapeutic effect". What this basically means is that too little of the drug is ineffective, while too much can be toxic. The manufacturer only needs to prove that the amount of the active ingredient in the bloodstream is identical to that of the brand name prescription.

By law the active ingredient in the prescription drug must be identical, but the inactive ingredients or "fillers" can differ. This may seem to be inconsequential, but often allergic and other negative reactions occur from these fillers or the interaction of the active drug with the fillers varies from the brand name's filler(s). According to the segment on ABC News, on average, the composition of generic drugs varies by approximately 3.5%, but at least 50 generic versions of drugs vary by as much as 10%.

There also remains that issue that there are more than one type of generic drugs that pharmacist use for the same prescription. For example, the popular sleep aid Ambien, has as many as 12 different generic versions. Due to the fact that 70% of prescriptions filled are generic versions, this remains a significant issue that most people are not informed of.

One way to avoid having to experiment with your prescription is to request to your physician prescribing the drug to write "do not substitute" on the prescription pad. There are certain instances when doctors firmly believe that the generic versions are inferior, such as topical medications popular with dermatologists. According to dermatologists, when it comes to topical solutions the concentration of the drug is greatly altered when the filler is substituted for a cheaper product.

A recent lawsuit against a manufacturer of the generic drug of Reglan resulted in the court agreeing with the consumer in the suit that manufacturers of generic drugs should not sell their versions of the drugs if the brand name labeling and prescription advice is inapplicable to the generic due to differences in the composition of the drug. In this case a woman was prescribed the generic version of Reglan, called metoclopramide, and the generic version made the patient develop tardive dyskineasia, a neurological disorder that produces involuntary movement of the muscles, after four years of use. The plaintiff argued that the generic version of the drug posed different risks and side effects, but this was not stated in the literature accompanying the prescription. The point of the suit was to force manufacturers of generic drugs to monitor the safety and efficacy of the drugs with the same standard of care that brand name drug manufacturers must use.

There is no question that in a country where health costs are skyrocketing purchasing and prescribing generic drugs saves both the consumer and the insurance companies a great deal of money, however, the cost cutting aspect of generic versions can not overlook the safety and effectiveness of using the drug. Medical warnings need to be tailored to each specific prescription and adverse effects of drugs need to be reported with the same standard of care that brand name drugs are imposed with.

Sources: Cuomo, Chris and Leamy, Elizabeth. "Generic vs. brand name drugs". Good Morning America (ABC). Transcript of October 27, 2009.

Jones, Barbara L. "Generic drug makers lose a pre-emption argument at 8^th circuit". Minnesota Lawyer. December 7, 2009.