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The 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.
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The FDA demands that generic drugs be just as strong, pure, and stable as brand name drugs. They must also be the same quality.
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Generics work in the same way and in the same amount of time as brand name drugs.
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They are cheaper because their makers don't have the costs of creating the new drug.
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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.
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Other companies can apply to the FDA to sell a generic when the patent is about to expire. These companies do not have the same up-front costs to research and develop the drug. So they can sell their drug at a lower cost.
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Also, once generic drugs are approved, there are more people trying to sell the drug. This keeps the price down.
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Today, almost half of all prescriptions are filled with generic drugs.
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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.
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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 active ingredients. Colors, flavors, and some other inactive parts may be different.
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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.
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Contact your doctor, pharmacist, or insurance company for information on generic drugs.
To learn more:
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Generic Drugs: www.fda.gov/cder/ogd/index.htm
FDA Office of Women's Health: www.fda.gov/womens/
Over-the-Counter Drugs
Over-the-counter (OTC) drugs are drugs you can buy without a prescription.
It is very important to read the label when using OTC drugs. It is the only way to know how to use the drug the right way.
FDA passed a law about labels on OTC drugs. The law says that all OTC products must have a new label called “Drug Facts.” This label will show people the best, safest way to use OTC drugs.
How is the new label different?
- It will use common words that are easy to understand.
- The print will be bigger, making it easier to read.
- The label will look the same, and be in the same place, on every product.
What will be on the label?
- Active ingredients—what is in the product that makes it work
- Purposes—what the drug is for
- Uses –what problems it is used to treat
- Warnings—who should not take the product, problems to watch out for
- Directions—how much to take, when to take it
- Inactive Ingredients—what else is in the product. People can see if they are allergic to something in the product.
How will the new label help me?
- It will help you compare products and choose the best one for your illness.
- The product will work its best because you can use it the right way.
- You will have all the information you need to stay away from problems.
To Learn More...
U.S. Food and Drug Administration
www.fda.gov/cder/otc/label/quesanswers.htm
www.fda.gov/usemedicinesafely/OTClabel.htm
or 1-888-463-6332 (1-888-INFO-FDA)
FDA/Office of Women’s Health
www.fda.gov/womens