What are generic drugs?
According to the U.S. Food and Drug Administration (FDA), generic medications are identical to brand name drugs in the following:
- Dosage form and route of administration
- Intended use
- Performance characteristics
Although the active ingredients in generic drugs are identical to those in brand-name counterparts, generics are usually sold at substantially lower pricesas much as 80 to 85 percent lower. The reasons for this are that drug manufacturers don't have to repeat expensive studies and research for ingredients and dosages that are already approved; they generally don't have to pay for expensive advertising, marketing and promotion; and several companies often are approved to manufacture the drugcreating a competitive market resulting in lower prices.
Generic drugs approved by the FDA must:
- Be identical to the brand name drug in strength, dosage form and route of administration
- Be manufactured under the same standards set by the FDA as the brand name drug
- Contain the same active ingredients as the brand name drug (inactive ingredients may vary)
- Have the same biological effects as the brand name drug
- Have the same use indications as the brand name drug
- Meet the same requirements for purity and quality as the brand name drug
Variations in Generic and Brand Name Drugs
The mass production of any medicationwhether generic or brand namecan result in small variations in purity, strength, absorption and other characteristics. The FDA sets limits on these disparities and determines how much variation is acceptable.
Although generic medications differ from their brand name counterparts in appearanceslightly different shape, different color, etc.according to the FDA, research shows that generics are just as effective as branded drugs. The FDA reports that the average difference in absorption between generic and brand name drugs is about 3.5 percent. However, the disparity is higher in some medications and lower in others, so talk to your health care provider about whether a generic drug is right for you.
Generic Drug Safety
Research is ongoing to help determine why some people experience adverse effects when switching from a brand name drug to a generic version or from one generic drug to another. According to the FDA, many of these reactions are actually known risks of the active drug ingredients.
Following FDA approval, the agency continues to monitor and investigate reports of adverse health effects and side effects associated with all medications, including generic drugs. It's important to talk to your health care providerespecially if you take prescription medication regularly.
Source: U.S. Food and Drug Administration (FDA)