Perhaps you have already had this experience: you go to fill a prescription and the pharmacist mentions that there is a generic available. You’ve noticed that generic drugs often cost less and wonder: how can I be sure they’re as safe and effective as brand name drugs?
By applying the rigorous standards established by law, the United States Food and Drug Administration ensures that generic drugs are as safe and effective as the brand name drugs they copy. Today, approximately 9 out of 10 prescriptions filled in the United States are for generic drugs.
Generics are as safe and effective as their branded counterparts
Imagine a copy of something that should work just as well as the original. It is a generic drug.
Generic drugs are formulated to work like their brand name counterparts. An FDA-approved generic drug must:
- Have the same active ingredients as the brand name drug. The active ingredients make the drug effective for a particular disease or condition. For example, atorvastatin calcium is the active ingredient in Lipitor cholesterol treatment.
- Have the same strength, dosage form, route of administration, and conditions of use as its brand name counterpart. If the brand name drug is a capsule and is taken orally, for example, the generic drug must also be a capsule taken orally.
- Treating the same illnesses or conditions.
Generic drugs must also be “bioequivalent” to their brand name counterpart. This means that the generic drug reaches the part of the body where it works at the same time and in the same amount as the brand name drug.
Just like brand name drugs, generic drugs must meet the same high standards of quality and manufacturing. These and other requirements allow the FDA to ensure that when patients take a generic drug, it is an appropriate substitute for its brand name counterpart.
Generic drugs may look different
Intellectual property sometimes prevents generic drugs from looking exactly like their brand name counterparts.
Although a generic and its brand name counterpart must share the same active ingredient(s), some formulation differences between a generic and its brand name counterpart may be permitted. For example, some generic drugs are not required to have the same inactive ingredients, such as colors and flavors, as their brand name counterparts. (An inactive ingredient is any component of a drug product other than the active ingredient.)
This can lead to certain differences in taste and appearance, for example. The FDA considers all of these differences before determining whether to approve a generic drug.
Generic drugs could cost less
Generic drug makers generally don’t have to repeat the extensive clinical studies that backed the approval of a brand name drug. Instead, generic drugs must meet the requirements outlined above. Generally, generic drug manufacturers do not pay for advertising, marketing or promotion. These are some of the reasons why generic drugs are often less expensive.
How to know if a generic drug is available
Not all drugs have currently approved generics. To find out if there is a generic version of your brand name medication available:
- Ask your pharmacist.
- Use the [email protected] database.
- Search for generic drugs using the FDA’s online Orange Book.
- View the most recent monthly approvals for First Generics.
If you have a question about a drug, you can call the FDA. The FDA’s Division of Drug Information (DDI) is ready to answer your drug-related questions to help keep you and your family safe. DDI pharmacists are available by email, [email protected], and by phone, 1-855-543-DRUG (3784) and 301-796-3400.