Generic Drugs: Safety, Reliability & FDA Standards

Generic drugs are non-brand-name medications that are released after the patent expires on a brand-name drug. They are "copies" of these brand-name drugs sold in pharmacies at reduced costs. Some issues have been raised regarding the safety of generics, but generic drugs are actually just as safe and reliable as brand-name drugs.

Ingredients

• The Food and Drug Administration (FDA) requires that generic drugs contain the same active ingredients in the same amounts as the brand-name medications they are formulated to replace.

Bioequivalence

• Generic drugs must demonstrate bioequivalence---that is, they must act the same way in the human body as their brand-name counterparts.

Testing

• In addition to proving bioequivalence in the laboratory, generic drugs are tested on healthy volunteers in a trial before being released.

Inspection

• The FDA regularly inspects manufacturing facilities for generic drugs in the United States; each factory is inspected about once every two and a half years. Foreign facilities are inspected less often, but the FDA recently opened offices in China and India to increase efficiency and frequency of inspections.

Appearance

• Generic drugs often look and taste much different than their brand-name counterparts. This is due to the inclusion of different inactive ingredients, which often affect taste and texture, and trademark laws that prohibit generic drugs from having the same "look" as other drugs.