(AP Photo/Mel Evans, File)

Generic Drugs

Has this happened to you? Your doctor writes you a prescription for a medicine, but the pharmacist gives you a different drug when you go to fill it. She tells you it is a “generic” drug.

A generic drug is a copy of a brand name drug. It works the same as the brand name drug. Usually, the generic drug is much cheaper. Insurance companies often have agreements with pharmacies to replace name brand names with generic drugs to save money for you and the insurance company.

Are generic drugs safe? Yes
The U.S. Food and Drug Administration (FDA) requires that all drugs be safe and effective. Generics use the same substances and work the same way in the body as brand name drugs. So they have the same risks and benefits as the brand name drug.

Are they as strong as brand name drugs? Yes
The FDA demands that generic drugs be just as strong, pure, and stable as brand name drugs. They must also be the same quality.

There might be some exceptions. When that happens, your doctor will write on the prescription that only the name brand should be used.

Will they take longer to work in my body? No.
Generics work in the same way and in the same amount of time as brand name drugs.

Why are they cheaper?
New drugs are developed under patents. A patent gives only that one company the right to sell the drug for a period of time. This protects those who create the drug and pay to research, develop, and market it.
Other companies can apply to the FDA to sell a generic when the patent is about to expire. Generic companies do not have the same up-front costs to research and develop the drug. They can sell their drug at a lower cost because their makers don’t have the costs of creating the new drug.
Also, once generic drugs are approved, there are more people trying to sell the drug. This keeps the price down.
Today, almost half of all prescriptions are filled with generic drugs.

Are brand-name drugs made in better factories? No
Both brand name and generic drug factories must meet the same standards. The FDA will not let drugs be made in poor quality factories. The FDA inspects about 3,500 factories a year to make sure they meet the standards. Often the same factories make both brand-name and generic drugs.

Why don’t the drugs look the same?
In the United States, laws do not allow a generic drug to look exactly like the brand name drug. A generic drug must use the same substances as brand name drugs. Colors, flavors, and some other inactive parts may be different.

Does every brand name drug have a generic form? No
Brand name drugs are protected by patent for 20 years. When the patent expires, other drug companies can create generics. But they must be tested by the maker and approved by the FDA.

What is the best source of information about generic drugs?
Contact your doctor, pharmacist, or insurance company for information on generic drugs.

To learn more, contact:
• FDA Center for Drug
Evaluation and Research
http://www.fda.gov/cder/ogd/index.htm
• FDA Office of Women’s Health
http://www.fde.gov/womens/

Source: FDA Office of Women’s Health.