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Are generic drugs really safe?

July 1, 1993

Has your pharmacist ever asked you about substituting a generic drug for your regular prescription? Here’s what you should know before you answer that question: Pill coatings, colorings or shapes may vary, but the active ingredient in a generic drug is chemically identical to the brand-name drug—and all generic drugs undergo rigorous testing by the U.S. Food and Drug Administration (FDA).

When a patent expires on a brand name drug, a generic manufacturer can apply to the FDA for permission to produce that drug. Generic drugs must meet the same stringent requirements and inspections for dosage strength, manufacturing controls and labeling, and must produce the same clinical results as the brand name medication.

However, since generic manufacturers don’t spend as much for research and development, clinical testing, advertising, sales or marketing, their products can be sold at lower prices—sometimes as much as 75 percent less. Many familiar drugs, such as ibuprofen and prednisone, were once brand-name prescription drugs.

“Generic formulations have a long track record and have been proven safe and effective,” said Marissa Schlaifer, R.Ph., M.S., director of Pharmacy Affairs for the Academy of Managed Care Pharmacy in Alexandria, Va. “About 50 percent of all prescriptions now filled are for generic medications.” Ask your doctor if switching to a generic might be appropriate for you. Or, ask your pharmacist for more information about what generic equivalents are available for your prescriptions. Generic drugs are not only just as safe and effective as brand name drugs, they can help improve the health of your checkbook, too.

The Academy of Managed Care Pharmacy is a professional association of pharmacists who work in managed care organizations. AMCP’s vision is improved quality of life through affordable and accessible medication therapy. Learn more at: http://www.amcp.org, or call (800) 827-2627.

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