Generic Medications - The Truth Behind The Myths

by Richard Clement

These days the subject of generic medications troubles many "anxious about our health government minds". Generic drugs are unsafe, not helpful as brand names for your diseases, they are made in unauthorized facilities ect. Is this the truth or is it just an attempt to favor some American drug manufacturers and pharmacies.

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."

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

 contain the same active ingredients as the innovator drug (inactive ingredients may vary)
 be identical in strength, dosage form, and route of administration
 have the same use indications
 be bioequivalent
 meet the same batch requirements for identity, strength, purity, and quality be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products.

So we can make the conclusion that: The Generic Drug is a drug which is bioequivalent to a brand name drug with respect to pharmacokinetic and pharmacodynamic properties.

Generic medicines must contain the same active ingredient at the same strength as the "innovator" brand, be bioequivalent, and are required to meet the same pharmacopoeial requirements for the preparation. By extension, therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use. Thus, in some cases, the "generic" product is actually the brand product but inside a different box.

The principal reason for the reduced cost of generic medicines is that these are manufactured by smaller pharmaceutical companies which do not invest in research and development into new drugs. The significant research and development costs incurred by the large pharmaceutical companies in bringing a new drug to the market is often cited as the reason for the high cost of new agents - they wish to recover these costs before the patent expires. Other reason for high prices is that every year pharmaceutical companies spend billions to market their products.

When a pharmaceutical company first markets a drug, it is usually under a patent that only allows the pharmaceutical company that developed the drug to sell it. This allows the company to recoup the cost of developing that particular drug. It will frequently cost millions of dollars to develop and test a new drug before it is approved for use.

After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.