Tuesday, September 18, 2007

What Everyone Should Know about Generic Drugs

NAPS — an estimated half of all prescriptions in the United States are filled with generic drugs. These products carry all the medicinal qualities (and side effects) of their brand-name counterparts, but generics tend to have one additional benefit: lower cost.

According to the U.S. Food and Drug Administration [FDA], a generic drug is a copy that is identical to a brand-name drug in dosage, refuge, strength, how it is interpreted, quality, performance and intended manipulation. New drugs, like other new products, are developed under patent protection. The patent protects the investment—including research, development, marketing and promotion—by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity on brand-name drugs are near expiry, manufacturers can apply to the FDA to sell generic versions.

What Everyone Should Know about Generic Drugs

As those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, there is greater competition and less publicizing, which keeps the price down. For example, in the 1950s, when the analgesic acetaminophen was developed, it was only usable under its brand name—Tylenol. Today, acetaminophen can be found in many other pain relief products, including generic and store-brand versions.

"FDA-approved generic drugs are bioequivalent and therapeutically equivalent to their brand name name counterparts," says Gary Buehler, director of FDA's Office of Generic Drugs. "People can use of goods and services them with total confidence."

Both brand-name and generic drug facilities must meet standards of good manufacturing processes. The FDA conducts about 3,500 inspections each year to ensure standards ar met. Generic firms have facilities comparable to those of marque firms. In fact, brand-name firms account for an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand drugs but sell them without the brand name.

Frequently Asked Questions

How does FDA ensure that my generic drug is as safe and effective as the trade name drug?

All generic drugs are put through a rigorous, multi-step review serve that includes a review of scientific data on the generic drug's ingredients and performance. Food and Drug Administration also conducts periodic inspections of the manufacturing plant, and monitors drug quality—even after the generic drug has been approved.

If generic drugs and brand-name drugs have the same active ingredients, why do they look different?

Generic drugs look different because certain inactive ingredients, such as colors and flavorings, may be different. These ingredients do not bear upon the performance, safety or effectuality of the generic drug. They look different because trademark pentateuch in the U.S. do not allow a generic drug to look exactly like other drugs already on the market place.

Is my generic drug made by the same company that makes the brand-name drug?

It is possible. Brand-name firms are responsible for manufacturing approximately 50% of generic drugs.

Ar generic drugs always made in the same kind of facilities as brand-name drugs?

Yes. All generic drug manufacturing facilities must meet FDA's standards of good manufacturing practices. FDA will not permit drugs to be made in substandard facilities. Food and Drug Administration conducts about 3,500 inspections a year to ensure standards are met.

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