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Generic Drugs What is a Generic Drug? Drug products sold in the United States are approved by the FDA whether they are brand name or generic. "Most people believe that if something costs more, it has to be better quality. In the case of generic drugs, this is not true," says Gary Buehler, Director of FDA's Office of Generic Drugs. "The standards for quality are the same for brand name and generic products." Despite the strict standards imposed by the FDA for approval of generic drugs, and their enforcement of these standards, a number of misconceptions about generic drugs persist (See "Myths and Facts about Generics"). New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity on brand-name drugs are near expiration, manufacturers can apply to the FDA to sell generic versions. "Much of FDA's review of generic drugs and brand name drugs is the same," Buehler explains (See "Same FDA Requirements for Brand-Name and Generic Drugs" below). There are eight major parts to the FDA's review of a firm's application to sell a generic drug:
When retired federal auditor Stuart Addison went to the pharmacy, he had the pharmacist fill his prescriptions with generic drugs. "My motivation is to keep the prices down," Addison said, noting that his insurance plan helped pay for his prescriptions. "My pocketbook isn't directly affected; but, in the long run, I'm helping to keep insurance premiums down." Generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies (according to the Congressional Budget Office). Even more billions are saved when hospitals use generics. "FDA-approved generic drugs are bioequivalent and therapeutically equivalent to their brand-name counterparts," says Buehler. "People can use them with total confidence." [ Top ]
Same FDA Requirements for Brand-Name and Generic Drugs
Myths and Facts about Generic 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 potent as brand-name drugs. Fact: FDA requires generics to have the same quality, strength, purity, and stability as brand-name drugs. 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. [ Top ]
What Is Bioequivalence?Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients. Since the safety and efficacy of the brand name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug. One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug. Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Brand-name drugs are subject to the same bioequivalency tests as generics when their manufacturers reformulate them. This article originally appeared in the September 1999 Special Report, "From Test Tube to Patient: Improving Health Through Human Drugs" U.S. Department of Health and Human Services Public Health Service - Food and Drug Administration [ Top ] |
