Brand Vs. Generic: What You Should Know Before You Enter the Pharmacy

When I first started out in the pharmacy business I was told one thing that would change my outlooks on generic drugs. The issue was brand vs. generic Coumadin. Coumadin is the brand name, a drug that has been around for decades, and the generic is warfarin sodium. Whenever the issue of brand vs. generic debate comes into play, this is the first drug I think of. Why is it so important on that outlook?

Prescribing Coumadin itself is an entirely different science. The skills needed to properly use the correct milligrams is very specialized, and not for the meek or unsure cardiologist. It is an anti-coagulant drug, meaning in laymen's terms "a blood thinner." Imagine your doctor prescribing too much of the drug and causing your blood to become too thin, a cut can be devastating. If the doctor does not provide a high enough dosage, a blood clot could be inevitable. This is not a drug to mess around with. Not for humans, or for rats. It was a popular poisonous agent used to kill rats for a long while. Now it is saving people's lives. Patients must be extremly aware of their dosing schedule and keep up with it. If not, the results could be tragic.
In 1997 the generic form of coumadin was approved. Three companies provided their own genric, claiming it was completely safe. Studies done in 1970's and 1980's claimed otherwise. They said that generics could change the anti-coagulation. Grant you, these studies were done before the FDA generic approval in 1997, but still to this done these rest results raise cause for concern.

In human terms, what is a generic drug, and how does the FDA say it's alright?

First, the drug has to have exactly the same dosage, intended use, and side effects. The generic cannot claim to do more than the brand. Generics are always cheaper than brand because the manufacturer does not have to spend the time nor money on developing a new drug. When numerous companies apply for an allowance to make a generic, this drives the cost down even more. Companies such as Watson, Wyeth, Ivax and Geneva-Sandova are four of the biggest generic makers out there.