The Truth About Generic Vs. Brand-Name Medications
C. Michael White, Pharm.D., Professor and Head, Department of Pharmacy Practice, University of Connecticut explores the generic medicines practice in the recent interview in The Huffington Post.
There has been a lot of debate about the use of generic drugs vs. brand names. Are generics really as effective? It pays to be informed since, according to the FDA, “nearly 8 in 10 prescriptions filled in the United States are for generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent through 2015.”
The excerpts :
Q: Why are brand names so much more expensive than generics?
Unlike the generic manufacturer, the original pharmaceutical company has to pay for more than just the actual production of that medication. The Tufts Center for the Study of Drug Development estimates that the cost to develop and win marketing approval for a new drug is $2.6 billion.
Q: What happens when a brand name goes generic?
At the end of an approximately seven-year period of exclusivity, the FDA allows one specific generic to be the first to market. That generic is given a period of time of exclusivity for about six months. At the end of that time period, any manufacturer that can prove that it can achieve the same drug concentrations in the blood that the brand name does can make a generic. Manufacturers of generics aren’t required to do studies in people to prove safety. It is assumed that if they can achieve same blood concentration, they will achieve same results."
Q: Do generics have to have the same recipe, effect, side effects?
They are very similar in terms of the active ingredient. According to the FDA, generic drugs do not need to contain the same inactive ingredients as the brand name product.
Q: So, will you always achieve the same effect with a generic as with a brand name?
Keep in mind that there is a lot of diversity among people. When they do the blood concentration studies, they do them in “average” people, but because the inactive ingredients and process of manufacturing are different, they can’t assure that everyone will achieve same blood concentrations.
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