Generc Medications

Are There Any Differences Between Generics and Brand-Name Drugs?

The Bottom Line on Generic vs. Brand-Name Drugs

What is a Generic Drug?

The active ingredient of a 'generic' medication (for example, of 'generic Paxil', which is Paroxetine) is chemically identical to the active ingredient of the corresponding branded medication. Because generic medications are often much cheaper than their branded counterparts, very many people choose generics (whether buying discount medications online or in traditional retail outlets), and many insurance companies actually require that they be used.

According to the FDA's Office of Generic Drugs:

A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

Are There Are Minor Differences Between Generics and Brand-Name Drugs?

However, it should be noted that current regulations permit a variation of approximately 20% either way in the bioavailability of the active ingredient. (The specifics of the permitted variation in bioavailability hinge on the FDA's technical definition of bioequivalence, which requires that there be no statistically significant difference in bioavailability. For the FDA's definition, see the agency's Guidance for Industry document, which sets out guidance on confidence intervals for test to reference comparisons across different types of medications, as well as the FDA's Code of Federal Regulations 320 document on bioavailability and bioequivalence requirements. Also see this 1999 Food and Drug Law Institute overview of the Hatch-Waxman Act of 1984.) In one study (Borgheini 2003), a full 31% variation was found in the blood plasma levels of a particular medication after a patient switched from a branded to a generic product. (Why does this happen? It may be accounted for by differences in the manufacturing process yielding different particle sizes that are absorbed at different rates, as well as other factors.)

The Bottom Line on Generic vs. Brand-Name Drugs

Almost half of all prescriptions today in the US are filled with generic drugs. Still, I am often asked if generic drugs are really as good as their brand-name counterparts. After all, goes the reasoning, don't you get what you pay for?

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic drug, one used for hypertension, is metoprolol whereas a brand name for the same drug is Lopressor.

Many people become concerned because generic drugs are often substantially cheaper than the brand-name versions. They wonder if the quality and effectiveness have been compromised to make the less expensive products. The FDA (U.S. Food and Drug Administration) requires that generic drugs be as safe and effective as brand-name drugs.

Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect.

As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug. Without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further.

So there's no truth in the myths that >a href="http://www.bestgenericdrugs.homestead.com">generic drugs are manufactured in poorer-quality facilities or are inferior in quality to brand-name drugs. The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs. In fact, the FDA estimates that 50% of generic drug production is by brand-name companies.

Another common misbelief is that generic drugs take longer to work. The FDA requires that generic drugs work as fast and as effectively as the original brand-name products.

Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws in the United States do not allow the generic drugs to look exactly like the brand-name preparation, but the active ingredients must be the same in both preparations, ensuring that both have the same medicinal effects.

In my view, provided medications are taken under the supervision of a qualified medical professional, there is very little advantage to buying branded medications if cheap generic drugs are available. The only difficulty, of course, is that it sometimes takes many decades before generics actually do become available. (See the separate page of background to the controversy about discount drugs.)