Generic Medications - The Truth Behind The Myths

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 unautorised facilities ect . Is this the truth or is it just an attempt to favour 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 manufacturered 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.

So 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 that we must disprove:
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.