Safety Issues With Generic 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.