Generic Drugs: Are They Safe Actually?
- Author Dorothy Health
- Published May 28, 2008
- Word count 517
A generic drug is very much safe as it is bioequivalent of a branded drug in every respect such as dosage form, strength, method of administration, characteristics and intended use. It should not be mistaken as cheap quality, unsafe drug because they are sold at substantially lower prices than the branded counterparts. It is estimated that consumers save $8 to $10 billion a year at retail pharmacies.
Usually patients get concerned about generic drugs as they are sold substantially cheaper than their branded versions. If you are contemplating to use them, let me assure you that the cost is no cause of worry, USFDA requires that generic drugs be as effective and safe as branded drugs and assures that that their quality hasn’t been compromised for the sake of reducing the cost.
Take an example of a generic drug used for the treatment of diabetes. The drug is metformin. Glucophage is a branded product of the same metformin. As you can see, brand names are more often than not capitalized while generic names are not. Getting back to the basics, active ingredients (in the above case, metformin) are what make drugs work. In addition, there are inactive materials known as excipients like binders, colors or flavors which do not have any role in the functioning of drugs on the body. If you are seeing different colors and/or shapes between generics and branded drugs, it is because physical characteristics are patented by branded drug producers and also USFDA requires them to be different.
Alright, how safe are the excipients, then? All excipients used in generic drugs must be approved by the FDA before they go to production. Secondly, generics producers often source both their active and inactive ingredients from the same vendors as the patented companies so as to ensure quality and conformation with FDA requirements.
There is a reason for physicians insisting upon using prescribed branded drugs; branded manufacturers endeavor to put a stop to cheaper, bioequivalent generics with direct-to-physician advertising insinuating pharmacist substitution is superseding physician's authority making sure that pharmacists dispense a Valium prescription for brand Valium and not equivalent generic diazepam in its place. (Have you heard of DAW which is an unwritten rule with physicians and an acronym for Dispense as Written?)
Actually there is hardly any truth in the stories that generic drugs are inferior in manufacturing methodology and quality to branded drugs. FDA makes no differentiation when it comes to approving manufacturing facilities and products; it has one yardstick for all drug manufacturers. It may surprise you to hear that many drug makers manufacture both branded and generic drugs simultaneously. According to FDA estimates, about half of all generic drugs produced in the USA is by brand-name companies.
It makes sense to go for generics, if they are available. If your insurer pays only for generics or demands a larger co-payment from you for a patented drug, tell your doctor if she or he prescribes branded drugs. If there is a noticeable difference in how the generic drug performs, you may have to petition the insurer to continue the branded products.
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