Medical Guide To Generic Drugs

All of us know that prescribed drugs may have generic substitution which are cheaper yet, according to the FDA, equally effective. In general, generic drugs are cheaper. A major drug store chain claims that generic drugs are 30 to 50% cheaper than the pioneer drug (the original, brand name product). This is substantial and clearly is a major factor in health care costs. It is in everyone’s best interest to safely select the least expensive drug.

According to the FDA, there is no clinical difference between brand and generic drugs. Generics, according to the FDA, are therapeutically equivalent to the brand drugs. They are not allowed to look identical but they must act identical. The look of a brand drug is the property of the owner of that drug and cannot be copied. The generic must have an appearance that allows for easy identification. The brand name of the innovator drug cannot be on the label of the generic drug. The generic label may only use the chemical name, i.e. diazepam instead of the commonly recognized brand name Valium or the chemical name for Zydol is Tramadol.

Generic Drugs Abuse

In response to the abuses in the industry in the late 1980’s, the FDA stepped up their surveillance to prevent illegal gratuities, fraud, obstruction of justice and non-compliance. The FDA’s Office of Generic Drugs closely regulates the industry. Generic manufacturers must submit to intense inspections of their manufacturing process and must demonstrate that they conform to strict regulatory standards. Though they are spared the need to replicate the extensive clinical trials that the pioneer drugs provided, they must show that their generic is bioequivalent and that it falls into acceptable parameters set for bioavailabilty (the extent and the rate that the body absorbs the drug).

There are certain drugs in which small changes in the dose or blood concentration could potentially affect drug efficacy or safety. The FDA describes these drugs as having a narrow therapeutic range and do not feel that any changes in patient monitoring are necessary when brand and generic are switched. Most physicians will increase patient monitoring whenever a brand is switched to a generic to be safe. Increasing the frequency of protime testing at the time of Coumadin(brand) and warfarin(generic) substitutions makes good sense. The claims of some patients that generics do not work as well as brand drugs has never been substantiated but the FDA feels that the perception of decreased efficacy or increase side effects comes from closer attention by the patient to their symptoms.

The FDA wants to assure us that there is therapeutic equivalence between brand and generic drugs and that clinically they are equal. Your health care practitioner does not need to change your usual monitoring, either by more frequent testing or examinations. The conclusion of any research into this subject points strongly to the use of generics whenever possible.

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