Generic Drugs Undergo Rigorous FDA Review

By Sondra Forsyth

Maybe you’ve had this experience: You go to fill a prescription, and the pharmacist mentions there is a generic available. You’ve noticed generic drugs often cost less and wonder: How can I be sure they are as safe and effective as brand name drugs?

Applying the rigorous standards set out by law, the U.S. Food and Drug Administration ensures that generic drugs are as safe and effective as the brand name drug products they copy. Today, about 9 in 10 prescriptions filled in the U.S. are for generic drugs.

Generics Are as Safe and Effective as Their Brand Counterparts

Imagine a copy of something that is expected to work as well as the original. That’s a generic drug.

Generic drugs are formulated to work like their brand name counterparts. A generic drug approved by the FDA must:

• Have the same active ingredients as the brand name drug. Active ingredients make the drug effective for a particular disease or condition. For example, atorvastatin calcium is the active ingredient in the cholesterol treatment Lipitor.
• 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 must also be a capsule taken orally.
• Treat the same diseases or conditions.

Generic drugs also must be “bioequivalent” to their brand name counterpart. That means the generic drug gets to the part of the body where it works in the same time and in the same amount as the brand name counterpart.

Just like brand name medicines, generic drugs must meet the same high quality and manufacturing standards. These requirements, among others, enable the FDA to ensure that when patients take a generic medicine, it is an appropriate substitute for its brand name counterpart.

Generic Drugs Can 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), certain differences in formulation 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 flavorings, as their brand name counterparts. (An inactive ingredient is any component of a drug product other than the active ingredient.)

That can lead to certain differences in taste and appearance, for example. The FDA reviews all these differences before determining whether to approve a generic drug.

Generic Drugs Might Cost Less

Generic-drug manufacturers generally do not have to repeat the extensive clinical studies that supported the approval of a brand name drug. Rather, generic drugs need to meet the requirements described above. Generally, generic-drug manufacturers do not pay for advertising, marketing, or promotion. Those are some of the reasons that contribute to generic medicines often being less expensive.

How to Know if a Generic Drug Is Available

Not every drug has a currently approved generic. To find out if there is a generic version of your brand name medicine available:

• Ask your pharmacist.
• Use the Drugs@FDA database.
• Search for generic drugs using the FDA’s online Orange Book.
• Consult the most recent monthly approvals for First Generics.

If you have a question about a medication, 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, druginfo@fda.hhs.gov, and by phone, 1-855-543-DRUG (3784) and 301-796-3400.