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Generic Drugs

"Since generic drugs generally sell for less than brand name drugs, many people falsely believe that generics must be inferior to brand-name products. Generic drugs contain exactly the same active ingredients as the brand-name drugs and are just as safe and effective."

Doug Sporn, Director
FDA Office of Generic Drugs

Generic Drugs, Are They As Good as Brand-Names?



Medical Author: Melissa Stoppler, M.D.
Medical Editor: Barbara K. Hecht, Ph.D.

"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.

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 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.

...

Resource: Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), 5600 Fishers Lane, Rockville MD 20857.

 

 

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