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Generic Drugs-What are They? Are they Safe?

If you have been trying to find a way to reduce the cost of your prescription drugs, you may have heard that you should try using generic drugs in place of the brand-name drugs that you regularly use.  But, if like many Americans, you are unsure what taking a generic drug would mean, we’ve put together a short primer of the most commonly asked questions regarding generic drugs.

What is a Generic Drug?

generic prescriptionA generic drug is a legal copy of a brand-name drug whose patent has expired.  When a pharmaceutical company develops a new drug, it obtains a patent for that drug.  The patent protects the developer’s investment in developing the drug.  Once the drug is patented, no one else can legally sell the same drug for 17 years.

Brand name drugs are expensive because when we purchase them, we are paying for the research and development costs, the costs to obtain U.S. Food and Drug Administration (FDA) approval, the marketing costs, and any other costs that the developing pharmaceutical company incurs in bringing the drug to the market.  Because a generic drug company is only paying manufacturing costs, generic drugs are virtually always a small fraction of the price of the original brand-name.

Not all brand-name drugs have a generic version.  In most cases, recent drugs are still under patent and therefore not eligible for legal copying.

What is the Difference Between a Brand-Name Drug and a Generic Drug?

The FDA considers generic drugs to be “identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”  However, what does that really mean?
To be a “bioequivalent,” a generic drug is required to have the same active ingredients as the brand-name drug.  In most cases, inactive ingredients differ between the versions.  In addition, trademark laws require that generic drugs appear different than their brand name equivalents, so the generic drug may have a different color, shape or taste than the original brand name drug.

Are Generic Drugs Safe and Effective?

To assure quality, safety and effectiveness, the FDA puts all generic drugs through a thorough review process, including a review of scientific information about ingredients and performance.  In addition, the FDA requires that generic drug manufacturers meet the same manufacturing plan standards as those of brand name drugs.

Despite the FDA’s finding of bioequivalency, some patients have reported reactions to their new medication when switching from brand name to generic or vice versa.  These may be due to differences in the inactive ingredients or variations in the amount of active ingredient or the release of the active ingredient in the new drug.  As with any new medication, if you have any side effects or have any concerns about changes that have occurred since switching your drugs, you should contact your doctor immediately.