WASHINGTON (press release)—Perhaps you’ve had this experience: You go to your local pharmacy to fill a prescription from your doctor and the pharmacist confirms there is a generic available.
“If it’s a copy, it must not be as good,” you think. You would be wrong.
What are generic drugs, and how does the Food and Drug Administration ensure that they are as safe and effective as brand-name drugs?
A brand-name drug is often patented to protect it from competition and thus to help the drug manufacturer recover the development costs. Several years later when the patent expires, other drug companies can copy the brand name drug and seek FDA’s approval for its generic version.
Today more than 8 in 10 prescriptions filled in the United States are for generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent.
Because generic drug makers are not required to repeat the clinical trials of new drugs and generally do not pay for advertising, marketing and promotion, generics are usually substantially less expensive than brand name drugs. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 billion to $10 billion a year at retail pharmacies. Billions more are saved when hospitals use generics.
To obtain FDA approval, generic drug makers must prove that their product performs in the same way and is as safe and effective as the brand name drug. Therefore, health care professionals and consumers can be assured that FDA approved generic drugs have met the same strict standards as their brand name counterparts.
The generic drug approval process includes a review of scientific data on manufacturing, ingredients and performance. A generic drug approved by FDA that would be substituted by a pharmacist for a brand name drug will:
- Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.
- Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.
- Treat the same medical condition.
- Be absorbed into the bloodstream at a similar rate and over the same period of time.
- Meet the same requirements for identity, strength, purity and quality.
- Be manufactured under the same strict standards that FDA demands of brand-name drugs.