A Generic drug is a prescription drug which is a chemical equivalent copy of a Brand-Name drug. Generic drugs are formulated upon a manufacturer's Brand-Name drug patent expiration. Generic drugs are usually less expensive than branded drugs and are usually sold by their chemical formula or "generic" name. For example, Valium is a Brand-Name drug, whereas Diazepam is its chemically equivalent generic.
Myth - Generic 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 acctive ingredient in the same timeframe as the original product.
Myth - Generics are not as potent as brand-name.
Fact - The FDA rquires 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-benefits profile as teir brand-name counterparts.
Myth - Brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities.
Fact - The 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, brands-name firms account for about half of generic drug production. They frequently
make copies of their own or other brand-name drugs but sell them without the brand name.
Source: FDA Center for Durg Evalution and Research Special Report, August 2002
Drug products sold in the U.S. 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 the FDA's Office of Generic Drugs. "The standards for quality are the same for brand-name and generic products."
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 the FDA's review of generic drugs and brand-name drugs is the same," Buehler explains.
"FDA-approved generic drugs are bioequivalent and therapeutically equivalent to their brand-name counterparts," he continues. "People can use them with total confidence."
In addition to providing consumers a lower-cost option, generic drugs also enhance the development of new drugs.
"Generic competition helps keep the cost of drugs down," Buehler says. "It also encourages the research-based drug companies to keep finding newer and better medicines that have patent protection."
Sources: Health Affairs; Employers Countering Drug
Ad Campaigns article Feb. 24, 2003; U.S. Food and Drug Administration.