Taking a generic drug is not like buying a store-brand soap. With the soap you might notice a difference. It may smell a bit different. Maybe you need to use more of it per load of dishes or laundry than the brand-name product.
But the same isn’t true with generic drugs. Generic drugs are like brand name drugs.
When drug companies make a brand-name drug, they get a patent for that drug. A patent protects the drug company from other drug companies making and selling the same drug until the patent expires.
Once the patent on a brand-name drug expires, other drug companies are able to make a generic version. After getting approval from the U.S. Food and Drug Administration (FDA), the generic drug is made and sold under the active ingredient’s name.
So companies can get permission to copy another company’s product? Patents expire so that good ideas can be shared with more people. And it encourages inventors to come up with even better ideas.
Compare the common myths about generic drugs and discover the myth-busting facts.
How does the FDA allow a company to make and sell a generic drug:
Why should I care about bioequivalence?
Generics don’t have to repeat the long clinical trials that have already been used to create the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients.
Since the safety and usefulness of the brand-name product has already been proven in research and during many years of patient use, the FDA says that it is not necessary or ethical to repeat testing in human subjects for each generic drug that a company wants to sell.
Instead, companies that want to make generics must show that their product is bioequivalent to the brand drug. That means it is made in the same way with the same ingredients, and it acts the same in the body.
The rules for approving generic copies of drug products were established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Brand-name drugs are subject to the same tests as generics when their manufacturers change them.
SIGN IN to share your comments or REGISTER today to become a Connect member.
A Division of Health Care Service Corporation, a Mutual Legal Reserve Company, an Independent Licensee of the Blue Cross and Blue Shield Association. © Copyright 2019 Health Care Service Corporation. All Rights Reserved.
Telligent is an operating division of Verint Americas, Inc., an independent company that provides and hosts an online community platform for blogging and access to social media for Blue Cross and Blue Shield of New Mexico.
File is in portable document format (PDF). To view this file, you may need to install a PDF reader program. Most PDF readers are a free download. One option is Adobe® Reader® which has a built-in screen reader. Other Adobe accessibility tools and information can be downloaded at http://access.adobe.com.