Questions About Generics?
Generic drugs are tried-and-true versions of brand-name pharmaceuticals and have been used bymillions for decades.
Generic drugs contain the same active ingredients, in the very same strength, as brand-name drugs. When a medicine is first developed, the pharmaceutical company that discovers and markets it receives a patent on its new drug. The patent usually lasts for 20 years, to give the originating company a chance to recoup its research investment. After the patent expires, a generic version of the drug may become available. Generics are marketed under the drug’s chemical, or “generic,” name and meet the same U.S. Food and Drug Administration (FDA) quality and effectiveness standards as the original.
Generic pharmaceutical manufacturers must prove to the FDA that their version of a drug:
- contains the same active ingredient;
- is identical in strength, dosage form, and route of administration;
- has the same indications, dosing, and labeling; and
- provides the same efficacy and safety profile to patients (“bioequivalent”).
Generic medicines have to be safe and effective to be approved by the FDA. The FDA also requires generic drug manufacturers to:
- meet the same batch-to-batch requirements for strength, purity, and quality as the original manufacturer and
- follow the same strict “Good Manufacturing Practices” rules
U.S. trademark laws don’t allow generic drugs to look exactly the same as another drug already on the market. For that reason, the color and shape of a generic pill may be different than the brand-name. Sometimes it will have a different coating or flavor. These “inert ingredients” also are carefully considered by the FDA. Differences in taste or appearance do not affect the drug’s safety or effectiveness.
Some brand-name manufacturers charge customers higher prices in the United States than they do in other countries, where drug prices are regulated. Drug research is costly, and patent protection gives brand-name manufacturers at least 20 years to recover those costs—costs that generic manufacturers do not have. Brand-name manufacturers collectively spend billions of dollars in marketing new drugs to doctors and the public; they send their representatives to visit with doctors in their offices; and they pay for physicians’ trips to meetings and conferences to talk about their drugs with other doctors. Generic manufacturers rarely spend money on advertising and marketing—another important way they keep their costs down.
According to the National Association of Chain Drug Stores, in 2007, the average retail price of generic prescription drugs was $34.34. The average retail price of brand-name drugs was more than three times higher: $119.51.
Not necessarily. Sometimes they are, but often they are no more effective than the tried-and-true drugs we already have. Marketing is used to try and convince both doctors and patients that new, expensive drugs are better, and they frequently are not. Occasionally, new drugs end up causing serious side-effects that were not discovered in their initial testing. Just because a product costs more does not mean it is better for you!
In some cases, yes. Brand-name companies make about half of generic drugs.
The easiest way to find out is simply to ask your doctor or pharmacist. There are also online resources, such as those listed at the right.