Generic Drugs Are They The Same Medicine?

October 26, 2013

Perhaps you’ve had this experience: You go to your local pharmacy to buy medicine. You’re inclined to go with the familiar brand name product, the one you know from commercials and other advertising. But the generic version is much less expensive.

“If it’s so inexpensive, it must not be as effective or safe,” you think.

You would be wrong.

You’re not alone. Food and Drug Administration (FDA) pharmacist Brenda Stodart, Pharm.D., who for 14 years has answered questions on FDA’s Drug Information line (1-855-543-DRUG ) says, “Every day without fail we educate consumers and health care professionals about the safety and efficacy of generic drugs.”

So, what are generic drugs and how does FDA ensure they are a safe and effective alternative to name brands?

When a new, FDA-approved drug goes on the market, it may have patent or exclusivity protection that enables the manufacturer to sell the drug exclusively for a period of time. When those expire or no longer serve as a barrier to approval, other companies can make it in generic form. FDA must approve the generic drug before it can be marketed.

Generic manufacturers are able to sell their products for lower prices because they are not required to develop a new drug from scratch with pre-clinical studies or to repeat the many costly clinical trials of new drugs, Khan says. Generally, they also do not pay for costly advertising, marketing and promotion.

According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

But not every drug has a comparable generic. To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA. You can also search for generic equivalents by using FDA’s “Electronic Orange Book.” You can also consult the most recent monthly approvals for “First Generics.”

FDA encourages consumers and health professionals to notify FDA of any adverse side effects found when using drugs and devices the agency regulates, by reporting them online to Medwatch, FDA’s safety information and adverse event reporting program, or by telephone at 1-800-FDA-1088.

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