FAQs about Generic Drugs

FREQUENTLY ASKED QUESTIONS ABOUT GENERIC DRUGS

• What are generic drugs?
  A generic drug is a duplicate that is the same as its brand-name drug. A generic drug is the same as its brand-name drug in many respects such as dosage, safety, strength, quality, intended use, and performance.
• Are generic drugs as safe as brand-name drugs?
  Yes, Generic drugs are safe. FDA requires that all drugs be safe and of good quality. Because generics use the same active ingredients and they work the same way in the body, thus they have the same risks and benefits as their brand-name counterparts.
• Are generic drugs as effective as brand-name drugs?
  Yes, they are. Because generics use the same active ingredients. FDA requires generic drugs to have the same quality, strength, and purity as brand-name drugs.
• Do generic drugs take longer time 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 products at substantial discounts.
• Are brand-name drugs made in more modern facilities than generic drugs?
  No. Both brand-name and generic drug facilities must meet the same standards. FDA conducts about 4,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.
• If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
  In the United States, trademark laws do not allow a generic drug to look exactly like its brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.
• Does every brand-name drug have a generic drug?
  No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This protects the innovator who laid out the initial costs to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
• What is the best source of information about generic drugs?
  Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.
• What is a Generic Initiative for Value and Efficiency (GIVE)?
  On October 4, 2007, the FDA launched the Generic Initiative for Value and Efficiency, or GIVE. The initiative will use existing resources to help FDA modernize the generic drug approval process.
• How does the FDA ensure that my generic drug is as safe and effective as the brand-name drug?
  All generic drugs are put through a multi-step review process that includes a review of scientific data on the generic drug’s composition and performance. FDA also conducts periodic inspections of the manufacturing plant and monitors drug quality – even after the generic drug has been approved.