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Source: FDA.gov / CDER (Center for Drug Evaluation and Research) The FDA is a U.S. Government agency which regulates the production of food, drugs and cosmetics and protects the consumer from unsafe products. What are generic drugs?A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. Are generic drugs as safe as brand-name drugs?Yes. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts. Do generic drugs take longer to work in the body?No. Generic drugs work in the same way and in the same amount of time as brand-name drugs. Why are generic drugs less expensive?Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs. Are brand drugs made in more modern facilities?No. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to 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. Why do brand and generic drugs look different?In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different. |
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