DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 02-7

(FDA Web site: www.fda.gov)

Revised: December 2003

FDA-Approved Bargain Drugs:

Generic Products Must Meet High Standards

Generic drugs are much appreciated for their cost-effectiveness. According to the Congressional Budget Office, they save

consumers an estimated $8

billion to $10 billion a year

compared with the price of

trade-name products. An equally

important attribute of generic

drugs is that they are reviewed

by the Food and Drug Administration to ensure that they provide the same level of benefit to

patients as their trade-name

counterparts. The FDA has

approved approximately 7,000

generic drugs for various treatments, including benign prostatic

hyperplasia, various ovarian and

breast cancers, and high blood

pressure.

The basic requirements for

approval of generic and tradename drugs are the same, although the generic drug manufacturer does not need to repeat

the safety and efficacy studies

conducted by the developer of

the original product. In approving a generic drug, the FDA

relies on its previous finding that

the original drug is safe and

effective. The generic version

must have the same dosage form,

ity, the labeling of the generic

drug, including directions for

use, must be virtually the same

as that of the trade-name product. Both generic and trade-name

drug companies are required to

submit information to ensure that

the approved products can be

manufactured to the FDA’s

specifications.

Following approval, both

generic and trade name firms

must submit data to the FDA

showing that their products

continue to meet the agency’s

specifications until the established expiration date. The FDA

regularly assesses the quality of

generic medications on the

market and thoroughly researches and evaluates reports

about their performance. A

recent FDA review found that

the average difference between

the bioequivalence of more than

270 generic drugs approved in

1997 and their trade-name

counterparts was 3.5 percent.

This is about the same as the

differences found between

batches of trade-name products.

For more information, visit the

FDA’s Web site at www.fda.gov/

cder/ogd.

safety, strength, route of administration, and conditions of use

as the trade-name product. The

drug’s sponsor must show that a

generic drug delivers the same

amount of its active ingredient in

the same amount of time as the

trade-name counterpart. This

bioequivalence is critical for

drawing the conclusion that both

the original and generic drugs

will produce similar therapeutic

results.

With the exception of language

protected by patents or exclusivProtection and Encouragement

The Drug Price Competition and

Patent Term Restoration Act of

1984 encourages the production of

generic medicines while protecting

the rights of brand-name manufacturers. The law builds in certain

protections for the original drug

developer in terms of patents and

market exclusivities, but it also allows sponsors of identical products

to apply for their approval by the

FDA without repeating the original

developer’s clinical trials. In addition, the law rewards a period of

exclusive marketing for a first generic version of a brand-name drug,

thereby encouraging generic firms

to challenge innovator patents.