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Myths and Facts about Generic Drugs

MYTH: Generics are not as potent as brand-name drugs.
FACT: FDA requires generics to have the same quality, strength, purity, and stability as brand-name drugs.

MYTH: Generics take longer to act in the body.
FACT: The firm seeking to sell a generic drug must show that its drug delivers the same amount of active ingredient in the same timeframe as the original product.

MYTH: Generics are not as safe as brand-name drugs.
FACT: FDA requires that all drugs be safe and effective and that their benefits outweigh their risks. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts.

MYTH: Brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities.
FACT: FDA won't permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year in all firms to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms account for an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

MYTH: Generic drugs are likely to cause more side effects.
FACT: There is no evidence of this. FDA monitors reports of adverse drug reactions and has found no difference in the rates between generic and brand-name drugs.

Same FDA Requirements for Brand-Name and Generic Drugs

Brand vs. Generic Chart Brand Name Drug Generic Drug
For reformulations of a brand-name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing. X X
FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed. X X
FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed. X X
FDA reviews the actual drug product. X X
FDA reviews the drug's labeling. X X
Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug. X X
Manufacturer must report adverse reactions and serious adverse health effects to the FDA. X X
FDA periodically inspects manufacturing plants. X X
FDA monitors drug quality after approval. X X

Next: FDA Ensures Equivalence of Generic Drugs >>

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