Generic Drug Safety

Are generic drugs safe?

According to the Food and Drug Administration (FDA), generic drugs are just as safe and effective as their brand name counterparts. In fact, the law requires it. By FDA regulations, any generic drug has to have the same active ingredients in the same amounts as its brand name counterpart. Generic drugs must also be bioequivalent to brand name drugs, meaning that the drug has to perform the same way in the body as the brand medicine does.

How are generic drugs tested?

In contrast to the lengthy testing a new drug undergoes, the approval process to market generics is usually limited to bioequivalence data from the laboratory, and the results of a trial with a few dozen healthy volunteers.

The FDA also regularly inspects the facilities that produce generic drugs. These facilities must meet the same standards as the factories that produce brand name drugs.

Do all generic drugs work the same way?

The Food and Drug Administration requires generic drugs have the same quality, strength, purity, and stability as brand name drugs. The FDA grades generic drugs for bioequivalence, and publishes that information in a compendium commonly referred to as the Orange Book. A small proportion of generic drugs (4 percent) are rated as "non-therapeutically equivalent," and a handful of those are considered "non-equivalent." If you're interested in looking up the generics you use and discussing that information with your doctor, the Orange Book is available online on the FDA's Web site.

It should be noted that a few older generic drugs have never been tested for bioequivalence. The FDA didn't start monitoring the safety of new drugs until 1938, and some generic drugs introduced before then were simply "grandfathered."

Is there a generic drug that's right for me?

If you're currently taking a brand name drug, or if your doctor suggests a new prescription, ask if there's a generic alternative. The switch could save you hundreds of dollars a year. (For more on cost savings of generics, see our story Generic Drug Savings.) If you're taking a drug with a narrow therapeutic index (a small range between what is safe and effective and what is not), your doctor may want you to stay on the brand name drug, especially if it is working well for you. If your doctor doesn't want to switch to generics for medical reasons, make sure that the "no substitutions" box on your prescription is checked and the pharmacist fills the prescription exactly as written.

No matter what drug your doctor prescribes, be sure to read the label carefully and follow the instructions to the letter. Whether it's a brand name or a generic, a medication is only safe and effective when taken as directed.

References

U.S. Food and Drug Administration. Generic Drugs. July 2009.

Nolan S . What every physician should know about generic drugs. Family Practice Management. March 2002. 9(3): 45-46.

American Academy of Family Physicians. Position paper. Drugs, Generic. 2001.

Henderson JD and RH Esham. Generic substitution: Issues for problematic drugs. Southern Medical Journal. 2001. 94(1): 16-21.

A Primer: Generic Drugs, Patents, and the Pharmaceutical Marketplace. The National Institute for Health Care Management, Research and Educational Foundation, June 2002.

U.S. Food and Drug Administration. Facts and Myths About Generic Drugs. July 2009.

U.S. Food and Drug Administration. Therapeutic Equivalence of Generic Drugs Letter to Health Practitioners. January 1998.

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